Monthly Archives: September 2021

AUGUSTA, Ga. (WJBF) Researchers at the Medical College of Georgia are finding promising results when using glycerin to treat psoriasis, an inflammatory condition in which cells build up and create dry, scaly patches on skin.

Dr. Wendy Bollag and her team have found glycerin stages a four-pronged attack against psoriasis.

It inhibits the growth and promotes maturation in skin cells, Bollag, a cell physiologist and skin researcher at the Medical College of Georgia and Charlie Norwood VA Medical Center, explains. It also shows when its converted to fat, it can inhibit inflammation. Even the glycerin itself tends to be good at decreasing oxidative stress, which is another byproduct of inflammation. It also seems to be good at helping to repair the barrier. It helps with the normalization of skin cells.

Glycerin is sold at pharmacies, and is an ingredient found in moisturizers and even sports drinks, according to Bollag. Her team found that when applied to skin topically, psoriasis symptoms were alleviated.

Its a moisturizer. It improves the barrier. It softens the skin. It helps get rid of skin cells that are piling up.

Because its a moisturizer, it tends to reduce the scaling that you tend to see with psoriasis, she adds.

Bollag suggests glycerin be mixed with water in a one-to-one ratio before it is applied onto effected areas of skin. If used daily, she says results can be seen within two weeks. However, Bollag admits this treatment may be best suited for mild cases of psoriasis. She suggests people with more severe cases use their prescribed medications and treatments to clear the psoriasis first, and then use glycerin to keep it from flaring up.

Go here to see the original:
MCG scientists see results treating psoriasis with glycerin - WJBF-TV

Clinically and statistically significant improvement in PASI-50 score achievedEDP1815 safety and tolerability data comparable to placebo in studyEDP1815 advancing towards registration studies in psoriasisManagement to host conference call at 8:00 a.m. ET

CAMBRIDGE, Mass., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing SINTAX medicines as a new modality of orally delivered treatments for inflammatory disease, today announced positive data from its Phase 2 study evaluating EDP1815 versus placebo for the treatment of mild and moderate psoriasis. A statistically significant reduction in the Psoriasis Area and Severity Index (PASI) score, as measured by the proportion of patients achieving at least 50% improvement in PASI from baseline at the week 16 timepoint, was observed in the study. EDP1815 is an investigational oral biologic currently in development for the treatment of a broad range of inflammatory diseases, including clinical programs in psoriasis, atopic dermatitis, and COVID-19.

These clinical results represent a significant advancement for those who live with inflammatory disease. This is the first Phase 2 study to demonstrate that we can harness the small intestinal axis to make a clinical impact on patients with an oral product candidate with safety and tolerability data comparable to placebo, said Simba Gill, Chief Executive Officer of Evelo. Based on these data, we intend to advance EDP1815 towards registration studies in psoriasis. We look forward to discussing our proposed next steps with health and regulatory authorities. This milestone brings us one step closer to realizing our vision of transforming healthcare by developing broadly acting oral, safe, effective, and affordable medicines to address the unmet needs of hundreds of millions of patients who live with inflammatory diseases.

In the Phase 2 study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint was the mean percentage change in PASI between treatment and placebo and was prespecified as a Bayesian analysis. The Bayesian approach provides an estimate of the probability that EDP1815 is superior to placebo. The 16-week primary endpoint gave probabilities that EDP1815 is superior to placebo ranging from 80% to 90% across the prespecified analyses and cohorts.

Story continues

The responder endpoint reports the proportion of patients who had a meaningful clinical response, which is defined as PASI-50 or greater. 25% to 32% of patients across the three cohorts who were treated with EDP1815 achieved a PASI-50 at week 16 compared to 12% on placebo. In cohorts 1 and 2 this difference in response rate was statistically significant (p <0.05). Cohort 3 was directionally similar (25% vs. 12%). The pooled PASI-50 response across all three EDP1815 cohorts, an exploratory analysis, was 29% vs. 12% for placebo and was also statistically significant with a p-value of 0.027. An increase in the number of capsules of EDP1815 did not lead to a dose response.

Additionally, several patients on EDP1815 achieved a PASI-75 or better, which was sustained or improved post treatment. For individuals who had a PASI-50 response or better, consistent effects in secondary and exploratory endpoints, including improvements in patient reported outcomes such as Dermatology Life Quality Index (DLQI) and Psoriasis Symptom Inventory (PSI), were observed.

EDP1815 was observed to be well tolerated in the Phase 2 study. The safety data were comparable to placebo and consistent with what was previously reported in a Phase 1b study. Adverse events (AEs) classified as gastrointestinal were comparable between active and placebo groups, with no meaningful differences in rates of diarrhea, abdominal pain, nausea, or vomiting. There were no related serious adverse events.

I am very encouraged to see this Phase 2 data of EDP1815 in psoriasis, said Benjamin Ehst, M.D., Ph.D., Board-certified Dermatologist, Investigator and Clinical Associate Professor with the Oregon Medical Research Center, and Chief Investigator of EDP1815-201. It advances our scientific understanding of how to treat systemic inflammatory diseases and offers the prospect of a truly novel modality of treatment for patients with psoriasis. A drug with the combination of efficacy and safety results as observed here will likely be well received by dermatologists and their patients with mild and moderate disease, who are often faced with limited treatment options.

EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 study designed to evaluate three doses of an enteric capsule formulation of EDP1815 versus placebo in 249 patients with mild and moderate psoriasis over a 16-week treatment period. In the study, the PASI scores were assessed by both mean changes from baseline and responder rates. The primary endpoint is mean percentage reduction in PASI score at 16 weeks. Secondary endpoints include the proportion of study participants who achieve a PASI-50 response or greater and other clinical measures of disease such as Physicians Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, PSI, and DLQI. Todays results report out on the initial treatment phase of the study, which is now complete, and includes the 16-week treatment period with a 4-week follow-up. A six-month follow-up phase of the study is ongoing.

Conference CallEvelo will host a conference call and webcast at 8:00 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 5177247. A live webcast of the event will also be available under News and Events in the Investors section of Evelo's website at http://ir.evelobio.com. The archived webcast will be available on Evelo's website approximately two hours after the completion of the event and will be available for 30 days following the call.

About PsoriasisPsoriasis is a common chronic immune-mediated inflammatory skin disease, affecting up to 3% of the population worldwide. The disease is driven by Th17-inflammation, which results in the formation of thick red plaques with scaling. Psoriatic lesions can appear anywhere on the body but are most often seen on the knees, elbows, scalp, and lumbar area. In addition to the skin lesions, there are systemic manifestations including arthritis and fatigue, and a strong association with depression and metabolic syndrome.

Patients with mild and moderate psoriasis are underserved by current treatments. Topical therapies do not control systemic inflammation, have low rates of compliance, and in the case of topical steroids are not recommended for long-term use. The majority of novel therapies, including injectable high-cost biologics, are only approved for patients with moderate and severe disease. Even in the severe patient population, the majority of eligible patients do not receive biologics, instead opting for topical therapies or oral systemic therapies, which are associated with tolerability issues and/or with monitoring requirements tied to safety concerns.

About Evelo BiosciencesEvelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that are designed to act on the small intestinal axis, SINTAX, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. Evelos first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelos therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

For more information, please visit http://www.evelobio.com and engage with Evelo on LinkedIn.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements concerning the development of EDP1815, the promise and potential impact of EDP1815, the timing of and plans for clinical studies, and the timing and results of clinical study readouts.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical studies, and the continuity of our business; that we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical studies, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; issues with the protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our managements and principal stockholders ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us.

These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the three months ended June 30, 2021, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

ContactInvestors:Kendra Sweeney, 239-877-7474ksweeney@evelobio.com

Media:Jessica Cotrone, 978-760-5622jcotrone@evelobio.com

Read the original post:
Evelo Biosciences Announces Positive Phase 2 Clinical Data with EDP1815 in Psoriasis; Confirms Ability to Harness the Small Intestinal Axis, SINTAX,...

Psoriatic arthritis (PsA) is an inflammatory disease that leads to both pain and swelling in your joints. In most cases, people with PsA develop psoriasis first.

Overall, PsA in the hips is less common than other areas of the body. You might notice swelling and pain in smaller joints first, including your fingers and toes. In fact, its estimated that less than 10 percent of people with PsA will experience symptoms in the hips.

Still, if youre experiencing hip pain and also have certain risk factors for PsA, take note of your symptoms and obtain a diagnosis from a doctor. They can help recommend a combination of medications, natural remedies, and other therapies to help reduce underlying inflammation and improve your quality of life.

If you have PsA in the hips, you may experience symptoms on one or both sides (asymmetrical or symmetrical).

PsA in the hip may include the following symptoms in the affected area(s):

If you have PsA, you may notice these symptoms in other affected joints. Additional symptoms of PsA include:

PsA is an autoimmune condition that develops when your body mistakenly identifies healthy cells as invaders, thereby attacking them. Its also possible to have more than one autoimmune disease at once, such as IBD.

Psoriasis is linked to PsA, and many people with this skin disease go on to develop PsA, with some estimates citing a rate of 7 to 48 percent.

Its estimated that PsA can develop in some people 7 to 10 years afterpsoriasis begins. The mean age for the onset of PsA is 39 years old.

You may also be at an increased risk of developing PsA if you:

Like other types of autoimmune diseases, PsA is more common in adults, though anyone can develop it.

Diagnosing hip PsA may be challenging at first. This is because joint pain and swelling arent unique to PsA. These symptoms may also be seen in rheumatoid arthritis (RA), lupus, osteoarthritis (OA), ankylosing spondylitis, and conditions with inflammatory arthritis.

While you shouldnt self-diagnose PsA of the hip, there are some key signs that differentiate this condition from other types of arthritis. For example, hip PsA may cause pain around the buttocks, groin, and outer thigh, while hip OA primarily affects the groin and the frontof the thigh.

Other conditions that can lead to hip pain may include muscle strains and stress fractures. A dislocated hip may occur from a recent accident or injury.

A doctor can help you determine whether your hip pain is attributed to PsA, another autoimmune disease, or a different condition entirely. They may also refer you to a rheumatologist, a specialist trained in diagnosing and treating autoimmune diseases of the joints, bones, and muscles.

While theres no single test to diagnose PsA, a healthcare professional may help identify this condition based on the following criteria:

Theres currently no cure for PsA. Instead, the condition is largely managed with both lifestyle changes and medications. Depending on the extent of pain and inflammation in your hip joints, your doctor may also recommend therapies or surgery.

If your hip pain is significantly impacting your overall quality of life, your doctor may recommend either over-the-counter (OTC) or prescription pain medications to help you manage your symptoms.

Possible medication options for hip PsA may include:

Other medications may also reduce underlying inflammation thats causing your hip pain. These types of medications are called disease-modifying antirheumatic drugs (DMARDs). Along with reducing inflammation, DMARDs can help prevent PsA from progressing.

While theres no natural cure for PsA, there are natural remedies and lifestyle habits that may help alleviate pain, decrease inflammation, and complement your medications. Consider talking with your doctor about:

Your doctor may recommend physical therapy as a complement to medications and natural remedies for PsA. The goal of physical therapy is to help you move better with PsA in the hip, the focus is to help increase your range of motion so you can walk more comfortably.

Each physical therapy program is tailored to the individual, but can include the following:

Surgery may be an option for severe PsA in the hip that isnt responding to other treatment measures. Your doctor might recommend a hip arthroplasty, also known as a total hip replacement.

A hip replacement is considered a major surgery, so your doctor will determine if youre a candidate based on the severity of PsA, along with your age and overall health.

There are numerous causes of hip pain, including PsA. You may be at an increased risk for developing PsA in the hips if you have certain risk factors such as psoriasis. Its important not to self-diagnose this condition so that you arent treating the wrong issue.

Even if your hip pain is notcaused by PsA, its still important to get a correct diagnosis as soon as possible. Letting diseases or injuries of the hip go can worsen your symptoms, and perhaps even affect your long-term mobility.

Go here to see the original:
Psoriatic Arthritis Hip Pain: Symptoms, Causes, and Treatments - Healthline

At UCB, we believe that collaborating with physicians, researchers and patients is fundamental to addressing the unmet needs of people living with immuno-dermatological diseases, such as psoriasis. We recognize that there is potential to improve the lives of people with psoriasis and we're looking forward to discussing the latest scientific advancements in this field with the dermatology community at the virtual European Academy of Dermatology and Venereology (EADV) Congress, taking place from 29 September - 2 October 2021. Now in its 30th year, the EADV Congress 2021 will bring together leading clinical experts across the fields of dermatology and venereology in a celebration of outstanding data and scientific exchange.

At this year's EADV Congress, we will be sharing the latest findings from our ongoing research in dermatology across 13 e-posters and one platform presentation. Attending healthcare professionals will also be able to virtually join five UCB-sponsored educational meetings, including our satellite symposium, and hear about the newest approaches and advances in psoriasis care from world-leading experts in dermatology. Following the congress close, delegates will also have virtual access to these meetings and sessions up until the end of the year.

We are proud to be sponsors of this year's EADV Congress. Platforms such as EADV 2021, which allow us to further our understanding of immuno-dermatological diseases like psoriasis remain as important as ever - particularly when we consider the impact these conditions continue to have on the lives of patients. Psoriasis affects approximately 125 million people worldwide and is a life-long condition, for which there is no cure. Much more than 'just a skin condition', psoriasis has been shown to have a profoundly detrimental impact on a person's quality of life. UCB's approach - from discovery to development to delivery - is designed around patient needs and their journey, we therefore remain determined to better understand the impact of immuno-dermatological conditions such as psoriasis, to help find solutions that allow patients to live life to the fullest.

EADV 2021 promises to be an outstanding educational learning experience with stimulating sessions, late-breaking science and an opportunity to connect with experts in dermato-venereology. We're ready to shine a light on how we are advancing care for people living with psoriasis and to be inspired by other groundbreaking work from our colleagues in the dermatology community. If you are a healthcare professional attending EADV 2021, we look forward to welcoming you to the UCB virtual booth and at our educational sessions.

Disclaimer

UCB SA published this content on 27 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 27 September 2021 09:51:04 UTC.

The rest is here:
EADV 2021: Shining a light on the latest science in dermatology - marketscreener.com