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The Evolutionary Perspective
Daily Archives: October 5, 2021
Posted: October 5, 2021 at 4:47 am
The four private space travelers who soared into orbit on SpaceX's historic Inspiration4 mission last month officially have their astronaut wings.
The civilian crew, which rode a SpaceX Dragon spacecraft into orbit on Sept. 15 and returned to Earth three days later, received their astronaut wings from the company on Friday (Oct. 1) in a presentation at SpaceX's headquarters in Hawthorne, California.
"Yesterday we were presented with our SpaceX astronaut wings," Inspiration4 astronaut Hayley Arceneaux, the mission's medical officer, wrote in a Twitter post Saturday. "This beautiful symbol of our journey means everything to me! Also if it looks like I'm crying, mind your business."
Photos: SpaceX's Inspiration4 mission in pictures
I cried when I got my wings!"
Arceneaux wasn't alone in her jubilation.
"I cried when I got my wings!" Sian Proctor, a geoscientist and space communicator who served as the Inspiration4 crew's pilot on the mission, wrote on Twitter.
SpaceX's astronaut wings pin has a Crew Dragon capsule at its center from which emerge a dragon's head and wings. The back is inscribed with each crewmember's name, call sign and mission role.The wings are provided by the company itself and are different from the commercial astronaut wings provided by the Federal Aviation Administration. The private suborbital spaceflight companies Blue Origin and Virgin Galactic also have their own astronaut wings that also differ from the FAA's pins.
In July, the FAA changed its qualifications for commercial astronaut wings to require crewmembers to demonstrate "activities during flight that were essential to public safety, or contributed to human space flight safety" in addition to their flight training and flight above 50 miles (80 kilometers). FAA officials have said that the agency does reserve the right to issue honorary commercial astronaut wings "to individuals who demonstrated extraordinary contribution or beneficial service to the commercial human spaceflight industry."
Inspiration4 was a three-day commercial space mission financed by American entrepreneur and billionaire Jared Isaacman, who bought four seats to orbit on a SpaceX Dragon and Falcon 9 rocket. Isaacman donated three of the seats to raise funds and awareness for childhood cancer research by St. Jude Children's Research Hospital.
Arceneaux, a St. Jude physician assistant and childhood bone cancer survivor, represented the hospital on the flight. Proctor and another civilian, aerospace data engineer Chris Sembroski, won their seats as part of public contests.They were the first all-civilian crew to fly in space without a professional astronaut, and Proctor became the first Black female spaceship pilot in history on the flight.
During their flight, the Inspiration4 astronauts spent three days circling the Earth, performing science experiments and gazing out the largest single window ever built for space, a dome-shaped cupola that SpaceX attached to the nose of the Dragon capsule for the mission. Their mission is the subject of a Netflix documentary series and raised over $200 million for St. Jude.
"Until we meet again, thank you to all the amazing people at @SpaceX who have done so much for me and @inspiration4x," Sembroski, Inspiration4's mission specialist, wrote on Twitter. "And most of all, thanks to my beautiful wife Erin who gave so much to support this dream on a most incredible journey."
According to SpaceX and the Inspiration4 teams, the private astronauts were invited to the company's headquarters Friday to share the experiences from their spaceflight. The astronaut wings presentation was apparently a surprise.
"Our Inspiration4 crew visited SpaceX's headquarters in Hawthorne, California yesterday, and was surprised with SpaceX Dragon wings," Inspiration4's outreach team wrote on Twitter.
Isaacman, who has not disclosed how much be paid for the Inspiration4 flight, thanked SpaceX on Saturday for the flight.
"It was great to see all our SpaceX friends and thank them for making this mission a success," Isaacman added on Twitter. "Incredible memories.
Editor's note: This story, originally posted on Oct. 3, was updated Oct. 4 to include details about the astronaut wings presented by Virgin Galactic, Blue Origin and the U.S. Federal Aviation Administration.
Email Tariq Malik firstname.lastname@example.org follow him@tariqjmalik. Follow us@Spacedotcom,FacebookandInstagram.
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Launch Agreement Signed By EnduroSat With Exolaunch For 2022 Mission Via SpaceX SatNews – SatNews Publishers
Posted: at 4:47 am
EnduroSat andExolaunch have signed a launch agreements for sending two EnduroSat smallsats into orbit aboard a SpaceX Falcon 9 launch vehicle. The 6U XL SharedSat smallsats, built by EnduroSat for customers, will be launched via Exolaunch in H1 2022 as part of SpaceXs SmallSat Rideshare Program.
The SharedSats are 6U XL smallsats with several multi-purpose payloads on a single bus. By simplifying access to space services through shared missions for a range of commercial, exploration and science customers, EnduroSat aims to significantly lower the entry barrier of operations in orbit.
The two SharedSats are part of the commercial EnduroSatsMissions. They foresee integration, validation, and testing, launch and operations of the satellite and hosted payloads. Direct access to the payload data will be made available in the cloud through EnduroSats Digital Mission Control. The software-centric smallsat architecture allows for multiple payloads to operate together reliably on a single platform with access to on-demand processing, power and pointing capability.
Exolaunch will ensure comprehensive rideshare mission management, satellite integration and deployment services for both EnduroSat missions. The launches are arranged by Exolaunch under its Multi-Launch Agreement with SpaceX. The new launch agreements mark the expansion of EnduroSats Shared Satellite Service and pave the way to the continued cooperation between the companies on future launches.
For both missions, Exolaunch will use their proprietary deployment technologies theEXOpod, a next-gen cubesat deployer with half a decade and 100+ of released satellites flight heritage, to deploy the EnduroSats satellites into their target SSO above 500 km, and the EXOport, a flexible, multi-satellite adapter designed to optimally accommodate several satellites on a single Falcon 9 port.
Were really pleased to have signed a launch agreement with Exolaunch, as it is another step in our mission to provide easy access to space. The Shared Satellite Service goal is to help drive innovation at the final frontier for visionary entrepreneurs, scientists, and technologists. At EnduroSat, we are eager to see the innovations that our customers willaccomplishin space and are happy to support them every step of the way, said EnduroSats Founder and CEO, Raycho Raychev.
Were proud to support EnduroSat with a variety of launch options and flexible mission management to address all their ongoing launch needs for the Shared Satellite Service program. Exolaunch has acquired outstanding flight heritage with Falcon 9 after signing a multi-launch agreement with SpaceX and is pleased to become a trusted launch partner for EnduroSat, said Jeanne Medvedeva, VP of Launch Services at Exolaunch. Its our common vision to make space accessible for everyone and we are honored to contribute to EnduroSats mission.
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Posted: at 4:47 am
What the hell was that?Big Boom
Residents in Jacksonville, Florida, heard a loud boom on Thursday night and it wasnt fireworks gone rogue or a massive fireball.
As it turns out, it was SpaceXs Dragon 2 spacecraft breaking the sound barrier right before splashing down in the Atlantic Ocean. Videos shared on social media show the blazing capsule burning through the atmosphere.
The boom was so loudthat several residents nearby reported they felt their entire houses shaking, according to Insider the kind of disruption that soon could become commonplace as space travel becomes more accessible than ever.
The spacecraft successfully completed the space companys 23rd commercial resupply mission to the International Space Station last week. The capsule spent about a month in spaceafter delivering supplies, scientific research equipment, and tech demonstrations.
It carried about 4,600 pounds of cargo, including frozen experiment specimens used to study diseases including Alzheimers, Parkinsons, and type 2 diabetes, according to NASA.
It was also carrying samples from a Japan Aerospace Exploration Agency investigation into special biomaterials capable of inhibiting muscle atrophy in microgravity.
Given the increased frequency of space launches, theres a very good chance more and more people will be able to witness the return of a spacecraft and,perhaps, hear it as well.
READ MORE: SpaceXs Dragon spacecraft caused a sonic boom in Florida after splashing down in the Atlantic, residents say [Insider]
More on SpaceX: In Newly-Released Documents, NASA Scoffed at Jeff Bezos Moon Lawsuit
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Posted: at 4:47 am
San Francisco, October 4
After spending three days in orbit, the world's first civilian mission of SpaceX's Inspiration4 returned to Earth safely last month and now mission commander Jared Isaacman has shared an incredible Earth image shot on iPhone.
"Amazing that an iPhone can take a shot like this. I really love the nosecone in the picture," Isaacman said in a tweet while sharing the photo.
Isaacman shared a clear video taken inside the cupola, which he said was shot on his iPhone during the flight. He added the crew were "so fortunate to have this perspective and we will do all we can to share the experience with the world".
It was the first civilian mission by SpaceX and the crew included Hayley Arceneaux, a physician assistant, Christopher Sembroski, an aerospace data engineer and Air Force veteran, and Dr Sian Proctor, a geoscientist.
Meanwhile, Arceneaux posted a 360-degree view of Earth from space and called the experience "absolutely life changing".
The fully automated Dragon capsule reached an unusually high altitude of 585 kilometres, surpassing the International Space Station by 160 kilometres. The Dragon's dome window, inspired by the Cupola on the ISSl provided the crew with incredible views of Earth.
"The Dragon performed a series of departure phasing burns to leave the circular orbit of 575 kilometres and then jettisoned its trunk ahead of de-orbit burns. After re-entering the Earth's atmosphere, the spacecraft deployed its two drogue and four main parachutes in preparation for the soft water landing," the company said on its website.
"We loved space but it's great to be home!" Isaacman wrote on Twitter.
"The absolute most incredible experience of my life. Can't wait to share more with you all! Red heart," added Arceneaux.
"What an amazing adventure! I'm so glad to be home on earth and to be back with my family. There is so much to share! What an amazing @inspiration4x team! Thanks @SpaceX!a Sembroski said.
"Inspiration4, which was aimed at inspiring humanity as well as to raise money for St. Jude, surpassed "the 200m goal", Isaacman shared in his tweet. IANS
Posted: at 4:47 am
The day is not far when India will see its own mega private aerospace company like Elon Musk-owns SpaceX or Jeff Bezos-run Blue Origin, taking travellers to the edge of space and beyond, Srinath Ravichandran, co-founder and CEO of rocket startup AgniKul Cosmos, has envisioned.
Ravichandran is ecstatic after Agnikul Cosmos was granted access to the Indian Space Research Organisation (ISRO) facilities and expertise for the development and testing of systems and subsystems of its rockets. He said that the pact with ISRO will allow them to ultilise its facilities to test out various sub-systems of their launch vehicle. "This will, in turn, help us with reduced capital expenditure and expedited testing," he said. "India can have its own SpaceX or Blue Origin kind of mega private space firm in the near future. There is so much support from the government and investors are open to invest too in the homegrown spacetech startups," Ravichandran added.
The next step, he added, will be to aim multiple launches per year and scale to the extent of having a launch once in two-three weeks. "Beyond that would be about making the vehicles more efficient, thereby providing even cheaper access to customers. We are doing this through a mix of innovations on various technologies in the vehicle," he informed.
Last month, Chennai-based Agnikul Cosmos received the nod by the Department of Space to carry out multiple tests and qualify its single piece 3D-printed semi-cryogenic engine and other systems of its rocket at various ISRO centres. This is the second pact that the Department of Space has signed with a rocket maker, after the first with Hyderabad-based Skyroot Aerospace on September 11. According to Ravichandran, their rocket engines are 100 per cent 3D-printed, that too in a single shot. "This allows us to directly assemble what comes out of the 3D printer in our launch vehicle. The big advantage of this is the ability to provide and enable rapid launch access and, at the same time, make customisable launch vehicles," elaborated Ravichandran.
He formed the startup with Moin SPM within IIT-Madras with a seed funding of Rs 3 crore, with an aim to develop and launch its first rocket in 2021 and subsequently develop ability to provide launch service for satellites. The current investors in the spacetech startup are Mayfield India, PI Ventures, Speciale Invest, Beenext, Artha and others. In June, India decided to allow private companies to establish and operate rocket launch sites within and outside the country, subject to prior authorisation from the government.
Similarly, any rocket launch (orbital or sub-orbital) from Indian or overseas territory can be carried out only with authorisation from Indian National Space Promotion and Authorisation Center (IN-SPACe), an independent body constituted by the Government of India, under the Department of Space (DOS). The launch could be from own or leased launch site and also from mobile platforms (land, sea or air) as per the Draft National Space Transportation Policy-2020 brought out by the Department of Space.
"Now that we also have to plan the entire engine building facility in-house, we are confident that we can control engine making end-to-end in India, thereby not only enabling 'make in India' but also 'design in India'," Ravichandran added.
Posted: at 4:45 am
Topical application of imiquimod (IMQ), a TLR7/8 ligand and potent immune activator, can induce and exacerbate psoriasis, a chronic inflammatory skin disorder. Recently, a crucial role was proposed for the IL-23/IL-17 axis in psoriasis. We hypothesized that IMQ-induced dermatitis in mice can serve as a model for the analysis of pathogenic mechanisms in psoriasis-like dermatitis and assessed its IL-23/IL-17 axis dependency. Daily application of IMQ on mouse back skin induced inflamed scaly skin lesions resembling plaque type psoriasis. These lesions showed increased epidermal proliferation, abnormal differentiation, epidermal accumulation of neutrophils in microabcesses, neoangiogenesis, and infiltrates consisting of CD4(+) T cells, CD11c(+) dendritic cells, and plasmacytoid dendritic cells. IMQ induced epidermal expression of IL-23, IL-17A, and IL-17F, as well as an increase in splenic Th17 cells. IMQ-induced dermatitis was partially dependent on the presence of T cells, whereas disease development was almost completely blocked in mice deficient for IL-23 or the IL-17 receptor, demonstrating a pivotal role of the IL-23/IL-17 axis. In conclusion, the sole application of the innate TLR7/8 ligand IMQ rapidly induces a dermatitis closely resembling human psoriasis, critically dependent on the IL-23/IL-17 axis. This rapid and convenient model allows further elucidation of pathogenic mechanisms and evaluation of new therapies in psoriasis.
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Imiquimod-induced psoriasis-like skin inflammation in mice ...
Posted: at 4:45 am
Dusan StankovicGetty Images
If youre one of the roughly 7.5 million Americans living with psoriasis, you know it isnt exactly fun. While you may go for years without symptoms, when you have a psoriasis flare-up, it can be everything from uncomfortable to downright distressing. And part of what makes it such a difficult condition to deal with is because you never know when a flare-up might occur and what could cause it. One biggie thats thought to cause flare-ups is food.
Certain types of foods appear to trigger or worsen psoriasis symptoms, and others may actually help tame signs of psoriasis, but everyone is different and foods that trigger flare-ups for some may not affect others with psoriasis, so pay attention to what seems to personally affect you, says Annie Gonzalez, M.D., F.A.A.D, a board-certified dermatologist at Riverchase Dermatology in Miami, Florida.
To help, we rounded up the best foods to eat if you have psoriasis and ones you should try to avoid, if you can.
Psoriasis is a skin disease with an unclear cause whats known is that it happens when the immune system goes into overdrive, triggering inflammation and inflammatory skin symptoms due to that overactivity that speeds up skin cell growth. The most common type of psoriasis (80%-90% of people with psoriasis have this kind) is called plaque psoriasis, characterized by patches of thick, raised skin that may itch and be red or partially covered in silvery-white scales; these patches can develop anywhere but tend to appear on the elbows, knees, lower back and scalp. Other ways a psoriasis flare-up may manifest is as tiny, salmon-to-pink colored bumps; smooth, raw-looking red patches around skin creases like the armpits; red, swollen skin dotted with pus-filled bumps; and as nail issues like tiny dents, rough crumbling nails, discoloration or lifting of the nail.
Weather, stress, infections (such as strep throat), smoking or secondhand smoke and certain medications, like those to treat high blood pressure are some common psoriasis flare triggers. Food is also thought to play a role in prompting of psoriasis flares. Specifically, inflammatory foods (a.k.a. foods that cause inflammation in the body) are thought to be common culprits, but more research in this area needs to be done. My advice is, if you notice your skin gets worse after eating certain foods, avoid and stop eating them to see what happens, says Dr. Gonzalez.
In general, eat a well-balanced diet thats high in fruits and vegetables and healthy fats this mix ensures youre consuming an array of nutrients and antioxidants that help prevent and reduce inflammation that could trigger a psoriasis flare-up.
alice dias didszoleitGetty Images
Fruits and veggies may reduce inflammation because theyre high in antioxidants and vitamins, which have been also been related to lower levels of oxidative stress and inflammation, says Gonzalez. Aromatics like onions and garlic are also smart to incorporate; they contain quercetin, an anti-inflammatory antioxidant.
Load up on:
Heart-healthy fats and omega-3 fatty acids have anti-inflammatory properties that can help decrease inflammation to alleviate or prevent symptoms.
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Many of these flavor enhancers are also thought to play a role in taming inflammation.
Load up on:
Foods to avoid if you have psoriasis:
Remember: Not every food on this list will definitely trigger a psoriasis flare-up, but if you do notice that your diet is affecting your skin, these inflammatory foods might be to blame, and cutting back or eliminating may help. Foods that have been known to trigger psoriasis include eggs, red and processed meat, canned produce, and packaged or processed foods, Gonzalez says.
These types of proteins tend to be high in saturated fat, an inflammation raiser and processed meats often contain preservatives, additives, and other flavor enhancers that may have a similar affect.
Avoid or limit:
These types of products often contain various inflammation triggers, such as added sugar, trans fat, preservatives, sodium and flavorings.
Avoid or limit:
Some research suggests that people with psoriasis may also be sensitive to gluten, a protein found in wheat, barley, and rye, possibly due to similar genetic and other inflammatory markers that affect people with Celiac disease.
Avoid or limit:
Everyone is different and different bodies will react differently to certain foods. Try jotting down which foods seem to impact your skin, so you can keep track and have that information on hand to consult with your doctor about your diet.
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Posted: at 4:45 am
The main factors behind the vaccine hesitancy are the potential adverse effects post-vaccination and effect on their autoimmune conditions, as well as lack of trial data, an analysis shows.
Individuals with psoriasis are hesitant to get the COVID-19 vaccination, but there is no differential risk of respiratory tract infection (RTI) and serous infection (SI), the results of 2 new studies presented at the European Academy of Dermatology and Venereologys (EADV) 30th Congress show.
Our analysis reveals no differences in risk of respiratory tract infections between biologics, including the newer IL-17 and IL-23 inhibitors, in a prospective psoriasis patients cohort. In addition, our preliminary results suggest that biological treatments do not impact psoriasis patients susceptibility to COVID-19 infections, although this needs to be further investigated, Lara van der Schoot of the department of dermatology at Radboud University Medical Center in Nijmegen, Netherlands, said in a statement.
These findings provide key clinical value and will help to guide patient decisions with regard to psoriasis treatment options and choice, she said.
Results from the first study show that COVID-19 vaccine hesitancy was driven by safety concerns and worries about aggravation of the individuals underlying conditions, as well as a lack of trial data.
Additionally, investigators said that individuals had no information on the effect of the COVID-19 vaccine on biologic therapy in immunocompromised individuals.
Treatments for psoriasis are often associated with an increase in infections, so in the second study, investigators examined the effect of biological therapies on the risk for RTI and SI, including COVID-19.
Investigators found that there was no differential risk of RTI among included biologics adalimumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab, and no association with serious infections.
In the first unique study, investigators collected real-world data from social media to minimize limitations from traditional hospital surveys.
Investigators gathered 10,922 social media posts between January and March 2021. They included individuals in France, Germany, Spain, the United States, and the United Kingdom, using pre-defined words, which were narrowed down to 625 posts that were manually analyzed.
The second study included 714 individuals with psoriasis, with 1325 treatment episodes from the BioCAPTURE registry, 2224 with RTI and 63 with SI.
Just 1.3% of RITs were reported to be serious.
Safety analysis of biologics and highlighting vaccine hesitancy: real-world data shines a light on the impact of COVID-19 on psoriasis patients. EurekAlert. News release. September 30, 2021. October 1, 2021. https://www.eurekalert.org/news-releases/929887
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Individuals With Psoriasis Are Hesitant to Get Vaccinated for COVID-19 - Pharmacy Times
Posted: at 4:45 am
Treatment with tapinarof 1%, a nonsteroidal topical cream in clinical development, was associated with durable control of plaque psoriasis in a 52-week phase 3 trial presented as a latebreaker at the European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting.
The drug has several unique features with meaningful clinical differences from other topical psoriasis therapies, according to Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health System, Detroit, Michigan.
"The currently available nonsteroidal topical therapies are typically associated with significant irritation. We did not see that with tapinarof," said Gold. This is one of several reasons she believes this drug will be a valuable addition if it receives regulatory approval.
Tapinarof is a small-molecule aryl hydrocarbon receptor (AhR) modulating agent. AhR is widely expressed in immune cells, including macrophages, mast cells, and antigen-presenting cells. It is believed that modulation of AhR signaling by tapinarof reverses immune dysregulation that is involved in the formation of psoriatic lesions.
The newly presented PSOARING 3 data with tapinarof 1% build on the data from the 12-week PSOARING 1 and PSOARING 2 trials, which were released in August 2020 but have yet to be published.
The primary endpoint in both of the 12-week trials, each of which enrolled about 500 patients with plaque psoriasis, was a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear). Relative to a placebo response rate of about 6% in both trials, the proportion of patients who achieved scores of 0/1 with tapinarof 1% was 35.4% and 40.2% in the PSOARING 1 and PSOARING 2 trials, respectively (P < .0001 vs placebo in both studies).
For the key secondary endpoint of 75% improvement in the Psoriasis Area and Severity Index (PASI75), the relative advantage for tapinarof over placebo was similar. The results were highly statistically significant (P < .0001) in both of the 12-week trials.
More than 90% of the patients who participated in PSOARING 1 and PSOARING 2 and were eligible for the open-label PSOARING 3 extension trial, according to Gold.
For the 79 patients with a score of 0 at the time of enrollment, tapinarof 1% was reapplied only if the PGA score reached 2 during the course of the study. For the 680 patients who entered with a PGA score of 1, once-daily applications of tapinarof 1% cream were maintained until a PGA score of 0 was achieved.
In the outcome analysis, response was defined as the proportion of patients with an initial PGA score of 2 who achieved PGA 0. A remittive effect was defined as duration of a PGA score of 0 or 1 while off therapy after achieving a PGA score of 0. Durability of response was defined as the proportion of patients who achieved a PGA sore of 0 or 1 at least once during the study while on therapy. This last outcome provided a test of tachyphylaxis.
"Overall, 40.9% of patients achieved complete disease clearance at least once during the trial, and 58.2% who entered the study with a PGA score of 2 or higher achieved a PGA score of 0 or 1," Gold reported.
For the 79 patients who entered PSOARING 3 with a PGA score of 0 and were off treatment, the median duration of a remittive effect was 115 days. For the patients who entered the trial with a higher PGA score but who achieved a score of 0 during the study (312 patients), the mean remittive effect after discontinuing therapy was 130 days.
There was no evidence of tachyphylaxis. Rather, "there was no loss of effect despite intermittent therapy observed over the course of the trial," Gold reported.
The most common treatment-emergent adverse events in PSOARING 3, as in the previous PSOARING studies, were folliculitis, which was observed in 24.0% of patients; contact dermatitis, which occurred in 5.9% of patients; and headache, which was reported in 2%. Rates of study drug discontinuations for folliculitis and contact dermatitis were 1.2% and 1.4%, respectively. Headache did not lead to any study discontinuations.
Calling tapinarof a "first-in-class nonsteroidal," Gold suggested that this is likely to be a useful adjunctive therapy for psoriasis control. It avoids the adverse events associated with long-term topical steroid use, and its tolerability might be particularly attractive for use in sensitive areas.
"This is likely to be very useful in patients who are looking for a topical therapy for skin folds or the face, where there is a need for well-tolerated topical treatments," Gold said.
There are a lot of reasons to be positive about a new, well-tolerated topical agent for psoriasis, particularly as an alternative to topical steroids, agreed Adam Friedman, MD, director of translational research and professor and chair of the Department of Dermatology at George Washington School of Medicine and Health Sciences, Washington, DC. He considers the data with tapinarof promising in general, but he also likes any new, effective topical psoriasis therapy.
"Patients and physicians are always hungry for new options, especially psoriasis patients, given many have 'been there and done that' with topical steroids," Friedman said.
"Topical steroids are not irritating, but long-term use beyond recommended dosing can lead to skin thinning, lightening, tachyphylaxis, and, if really abused, HPA [hypothalamic-pituitary-adrenal]axis suppression and adrenal insufficiency," he observed.
A topical therapy with a durable effect is particularly intriguing.
"The other issue with topical steroids is that psoriatic plaques return rather easily after stopping. The data I have seen with tapinarof show more sustainability after cessation, owing to its mechanism of action," Friedman said. Rather than its potential for application to sensitive areas, such as the face, the durability "to me is more interesting," he said.
He suspects that, owing to "the incurable steroid phobia that haunts many of our patients," an effective nonsteroidal topical option is also likely to lead to better compliance with topical treatment over time.
"A well-tolerated nonsteroidal topical drug will probably find an important place in the future management of chronic inflammatory diseases," Marius-Anton Ionescu, MD, PhD, a dermatologist at the Hpital Saint Louis, Paris, France, said in an interview. He referred to the positive effects of treatment with tapinarof in clinical trials in adults with atopic dermatitis, in addition to psoriasis.
Tapinarof 1% is also being investigated in a phase 3 study involving patients with moderate to severe atopic dermatitis. In that study, patients are as young as age 2 years. The drug is under review at the US Food and Drug Administration for the plaque psoriasis indication in adults.
Gold has financial relationships with Arcutis, Amgen, Bristol-Myers Squibb, Eli Lilly, Leo Pharma Ortho Dermatologic, UCB, and Dermavant Sciences, which is developing tapinarof and is provided funding for the PSOARING 3 trial. Friedman reports financial relationships with Amgen, Biogen, Encore, Galderma, GlaxoSmithKline, IntraDerm, Johnson & Johnson, Nerium, Novartis, Oculus, Onset, Pfizer, Sanova, and Valeant Pharmaceuticals. Ionescu has been a speaker or investigator (honoraria) for Celgene, Novartis, Lilly, and Uriage Cosmetics.
European Academy of Dermatology and Venereology (EADV) 2021 Annual Meeting: Abstract 2860. Presented September 30, 2021.
Ted Bosworth is a medical journalist based in New York City.
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Arcutis Submits Topical Roflumilast Cream New Drug Application to FDA for the Treatment of Adults and Adolescents with Plaque Psoriasis -…
Posted: at 4:45 am
WESTLAKE VILLAGE, Calif., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.(Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions, today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.
Roflumilast cream (ARQ-151) is a once-daily topical formulation of roflumilast, a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4), an enzyme that drives overactive immune responses. In clinical trials, roflumilast cream demonstrated robust efficacy coupled with favorable safety and tolerability that, if approved, would enable chronic use across the body, without many of the local tolerability issues associated with alternative treatments.
Today is a critical milestone for Arcutis in our efforts to bring innovative treatments to dermatologists and their patients, and is a reflection of our deep dermatology expertise, said Frank Watanabe, President and CEO of Arcutis. Individuals with plaque psoriasis currently do not have topical treatment options that offer a combination of good tolerability and the ability to be used for long periods of time, and that can be used on all parts of the body. If approved, roflumilast cream will be the first and only topical PDE4 inhibitor approved for psoriasis and an important non-steroidal treatment option for the millions of individuals struggling with plaque psoriasis. I want to thank the Arcutis team, as well as the clinical investigators, patients, and partners, for helping us reach this important milestone.
Psoriasis is a common, non-contagious, immune-mediated skin disease that affects more than 3% of the U.S. population. The majority of patients develop plaques, or raised, red areas of skin covered with a silver or white layer of dead skin cells. Psoriatic plaques are often itchy and sometimes painful, and can appear on any area of the body. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and areas where two skin areas may touch or rub together.
Topical treatments are the mainstay of therapy for the vast majority of psoriasis patients, particularly those with mild-to-moderate disease, as well as many moderate-to-severe patients who use topicals in combination with other treatments. However, existing topical treatments often force physicians and patients to make difficult trade-offs between tolerability and long-term use, requiring the use of multiple products or complicated treatment schedules. Roflumilast cream has been designed to address the challenges posed to dermatologists and patients by existing topical therapies and aims to simplify the overall management of plaque psoriasis.
Arcutis submission is supported by positive data from Arcutis pivotal Phase 3 program. The DERMIS 1 and DERMIS 2 (Trials of PDE4 inhibition withRoflumilast for theManagement of plaque PsoriasIS One and Two) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies to evaluate the safety and efficacy ofroflumilast cream 0.3%. Roflumilast met its primary endpoint and had an IGA Success rate of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and 37.5% compared to a vehicle rate of 6.9% (P<0.0001), in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favorable safety and tolerability profile.
About Roflumilast CreamRoflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor, roflumilast. Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.
About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of patients living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions, with one NDA submission now under review with the FDA and three Phase 3 clinical data readouts anticipated by the end of 2022. The companys lead program, topical roflumilast, has the potential to advance the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visitwww.arcutis.comor follow Arcutis on LinkedIn and Twitter.
Forward-Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding the potential for roflumilast to be approved for the treatment of adults and adolescents with plaque psoriasis, the potential to use roflumilast cream over a long period of time, or chronically, and the potential for roflumilast to revolutionize the standard of care in plaque psoriasis and other inflammatory dermatological conditions. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 16, 2021, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor Relationsemcintyre@arcutis.com