Daily Archives: May 25, 2022

ORLANDO, Fla. (Ivanhoe Newswire) - According to the National Psoriasis Foundation, more than eight million people in the United States have psoriasis. Now, research is showing this skin disease affects other organs in the body, including your heart.

When you think of psoriasis, you probably think of red, itchy, scaly skin patches. But scientists are finding out this common disease affects more than the skin.

Ben Kaffenberger, a medical dermatologist, at The Ohio State University explained That inflammation thats present in the skin thats causing this skin to swell and to thicken, it is much more than skin deep. Its causing a full body inflammatory process.

Recent studies have shown that inflammation impacts your bodys cardiovascular system.

That patient with psoriasis has a much higher risk of having heart disease, dying of heart disease, than a patient that doesnt, Dr. Kaffenberger told Ivanhoe.

A recent review of 90 studies found patients with psoriasis had a higher risk of ischemic heart disease, stroke, and peripheral arterial disease. They also had more heart disease risk factors, like obesity, high blood pressure, high cholesterol, and diabetes. Another study found psoriasis was linked to an increased risk of developing a heart arrhythmia. But there are things you can do to lower your risk of heart problems and improve your psoriasis symptoms, including stopping smoking, decreasing your alcohol consumption, eating more fresh fruits, fresh vegetables, less processed foods, detailed Dr. Kaffenberger.

Taking your prescribed medicines may also help. A study published in Cardiovascular Research found that biologic drugs used to treat psoriasis may also reduce the risk of heart disease.

Psoriasis is often mistaken for other skin diseases, like eczema, ringworm, hives, or even skin cancer. A dermatologist can help you determine if your skin rashes are psoriasis.

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Health Beat: Psoriasis inflames the heart | Health Beat | wfmz.com - 69News WFMZ-TV

By David Bautz, PhD

NASDAQ:SNGX

READ THE FULL SNGX RESEARCH REPORT

Business Update

SGX302 for Psoriasis

Soligenix, Inc. SNGX will be developing synthetic hypericin (the active ingredient in HyBryte) as part of a photodynamic therapy in mild-to-moderate psoriasis patients under the research name SGX302. Psoriasis is a common, chronic, noncontagious, multisystem inflammatory condition that most commonly presents on the skin of the elbows, knees, scalp, back, and thighs. There are multiple types of psoriasis, with plaque psoriasis, being the most common and affecting 80-90% of all individuals with psoriasis. Plaque psoriasis involves the hyperproliferation of epidermal keratinocytes that results in red or white, scaly, and typically itchy skin lesions. In addition, approximately 20% of psoriasis patients suffer from psoriatic arthritis, an inflammatory joint disease associated with psoriasis (Zacharlae, 2003). There is no known cure for the disease, thus depending upon the severity of the condition and how responsive it is to treatment, some patients are on therapy for life.

While psoriasis itself is not life-threatening, there are several conditions that are associated with the disease, including cardiovascular disease (Shlyankevich et al., 2014) and hypertension (Armstrong et al., 2013). In addition, patients with psoriasis have an increased risk for a number of non-skin cancers, including cancer of the lung, upper gastrointestinal tract, urinary tract, liver, and pancreas (Richard et al., 2013).

The severity of psoriasis is dependent on how much of a person's body surface area (BSA) is affected by the condition. Mild psoriasis typically covers

Soligenix previously tested synthetic hypericin in a small Phase 1/2 trial involving 13 patients with psoriasis (Rook et al., 2010). Results showed that of the 11 evaluable patients, six responded to treatment with hypericin. There were no deaths or serious adverse events and the only reported adverse events were mild to moderate and included itching, burning, erythema, and pruritis at that application site.

The company is currently evaluating different topical formulations of synthetic hypericin while at the same time working with psoriasis experts to finalize a clinical trial protocol. We anticipate a Phase 2a study initiating in the second half of 2022. We estimate that the company has sufficient capital to conduct the trial without the need to raise additional capital.

HyBryte NDA Anticipated in Second Half of 2022

Soligenix previously completed a Phase 3 clinical trial of HyBryte (SGX301, synthetic hypericin) in patients with cutaneous T cell lymphoma (CTCL). The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial was a randomized, double blind, placebo controlled study that enrolled 169 patients with either Stage IA, IB, or IIA mycosis fungoides (the most common type of CTCL) (NCT02448381).

The trial consisted of three treatment cycles, with each cycle lasting eight weeks. Each study subject had three target lesions treated during the trial. In Cycle 1, patients were randomized 2:1 (n=116 for SGX301; n=50 for placebo) to receive twice weekly treatment of either 0.25% SGX301 or placebo (an ointment with the same light exposure as for SGX301) for six weeks, with treatment response determined at the end of the eighth week. In Cycle 2, all subjects received 0.25% SGX301 on their target lesions, and for those that decided to continue in the trial there was a third treatment cycle where 0.25% SGX301 was applied to all of the patient's lesions.

The results for Cycle 1 showed a statistically significant treatment response in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessed at 8 weeks with 16% of patients receiving SGX301 responding compared to only 4% receiving placebo responding (P=0.04).

In Cycle 2, a total of 155 patients received 0.25% SGX301 on their target lesions (110 receiving 12 weeks of SGX301 and 45 receiving six weeks of placebo treatment followed by six weeks of SGX301 treatment). The results of Cycle 2 showed that continued treatment out to 12 weeks resulted in increased efficacy as shown by a 40% responder rate (P0.0001 compared to both placebo and six-week treatment data). Response rates further improved in Cycle 3 with 49% of patients electing to receive SGX301 for 18 weeks demonstrating a 50% or greater reduction in the combined CAILS. (P0.0001 compared to the end of Cycle 1).

Importantly, after 12 weeks of treatment with HyBryte, there is a similar response on both patch (37% response; P=0.0009) and plaque (42% response; P0.001) lesions when compared to Cycle 1 placebo lesion responses.

HyBryte is a safe and well tolerated CTCL treatment that shows positive effects in a relatively short period of time and has increasing efficacy with continued use. Since CTCL is a long-lasting condition, safety and tolerability are at the forefront of prescribing physicians concerns when treating patients, and many other CTCL therapies have a number of potential serious side effects, particularly with extended use. We believe the data that Soligenix has compiled for SGX301 in treating CTCL positions it as a promising front-line therapy for a large percentage of patients.

Soligenix is now in a position to submit an NDA to the U.S. FDA for HyBryte in the second half of 2022. HyBryte has received both Orphan Drug and Fast Track designations from the U.S. FDA as well as Orphan Drug designation from the European Medicines Agency (EMA).

The company is planning to commercialize HyBryte in the U.S. in lieu of seeking a commercialization partnership. Since the CTCL market is a specialized market, Soligenix can cost effectively market the drug with a launch cost of less than $10 million. This way, the company is able to keep 100% of the drug's value. For overseas markets, we anticipate a commercial partnership and the company is currently in discussions with potential partners. Approval will be sought first in the U.S. followed by other key markets worldwide.

Arbitration with Emergent BioSolutions Offers Potential Upside

Soligenix is currently involved in an arbitration dispute with Emergent BioSolutions, Inc. EBS in which Soligenix alleges that EBS fraudulently induced the company into entering into contracts with its subsidiaries and that the subsidiaries breached agreements with Soligenix. The disputed agreements pertain to the manufacture of RiVax bulk drug substance (BDS) that Emergent released despite the BDS being out-of-specification. This resulted in Soligenix having to suspend the Phase 1c trial evaluating RiVax in healthy adults. Soligenix presented its case at an arbitration hearing in January 2022 and we anticipate a decision on the case this summer. Manufacturing issues have been a problem for EBS in other circumstances, as shown in the report from the House Select Subcommittee on the Coronavirus Crisis titled "The Coronavirus Vaccine Manufacturing Failures of Emergent BioSolutions" from May 2022. While difficult to predict how the arbitration may be decided, the fact that EBS has a history of poor manufacturing practices likely bodes well for Soligenix, which is seeking in excess of $19 million from EBS.

Financial Update

On May 13, 2022, Soligenix announced financial results for the first quarter of 2022. The company reported revenues of $0.2 million for the first quarter of 2022, compared to $0.1 million for the first quarter of 2021. The revenues are derived from government contracts and grants to support the development of RiVax along with grants to support the development of SGX943, ThermoVax, and CiVax. R&D expenses for the first quarter of 2022 were $1.7 million, compared to $1.3 million for the first quarter of 2021. The increase was primarily due to increased expenses associated with the preparation of the upcoming HyBryte NDA filing. G&A expenses for the first quarter of 2022 were $2.6 million, compared to $1.0 million for the first quarter of 2021. The increase was primarily due to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc.

Soligenix exited the first quarter of 2022 with approximately $22.9 million in cash and cash equivalents. As of May 6, 2022, Soligenix had approximately 43.1 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 47.6 million.

Conclusion

Soligenix has a number of important milestones/events upcoming in 2022, including the NDA filing for HyBryte and the initiation of a psoriasis clinical trial for SGX302, both of which we anticipate in the second half of 2022. The current cash position, along with additional financial instruments available to the company, should provide funding into 2023, and the arbitration outcome with EBS provides potential upside to the company's cash position. We have removed CiVax from our model as the current COVID-19 vaccines are seeing oversupply issues and we believe there is not likely to be a follow up vaccine market. With this change our valuation decreased to $4.00 per share.

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SNGX: Phase 2a Trial of SGX302 in Psoriasis to Initiate in Second Half of 2022 - Benzinga - Benzinga

BARCELONA, Spain, May 23, 2022 Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced today the commercial launch in Denmark of Wynzora cream (50 g/g calcipotriol and 0.5 mg/g betamethasone as dipropionate), developed for the topical treatment of mild to moderate plaque psoriasis in adults including scalp.Denmark joins Spain, Germany and the United Kingdom, which were the first European countries to make the cream available on prescription. Following the launch of this innovative topical, Almirall became the only biopharmaceutical company in Europe to offer psoriasis patients multiple options covering the entire spectrum of the disease, from topicals to oral systemics and biologics.

Powered byPAD Technology, a new method of mixing oil and water, Wynzora Cream is the only calcipotriol and betamethasone dipropionate topical that allows the combination of active ingredients in an aqueous cream2,3. Wynzora offers high efficacy and fast onset of action within 1 week.3,4 The results from a pooled analysis of two randomized Phase III trials demonstrated that this CAL/BDP PAD-cream offered superior efficacy and patient quality of life in the topical treatment of psoriasis in comparison to the calcipotriol and betamethasone dipropionate gel formulation for all efficacy endpoints including PGA treatment success, mPASI, and PASI75 after 8 weeks of once-daily use4.

After eight weeks of treatment, the clinical investigation also showed that a significantly greater proportion of subjects treated with CAL/BDP PAD-cream reported that psoriasis had no effect at all on their life (DLQI 0 or 1) compared to CAL/BDP gel4. Superior patient treatment convenience (PTCS) at Week 8 was also achieved with CAL/BDP PAD-cream compared to the CAL/BDP gel.4

The results of pooled data from Phase III clinical trials were published in the Journal of the European Academy of Dermatology and Venereology (JEADV)4.Psoriasis is one of the world's most prevalent skin diseases, affecting approximately at least 100 million individuals worldwide5 and about 2.2% of adults in Denmark (102,000 estimated people)6. The disease negatively affects quality of life and represents a significant burden in the daily life of 71% of patients[vii], affecting the overall emotional wellbeing of 88% of people who suffer from the condition[viii].

I find it highly commendable that new innovation and improvement in topical treatment of psoriasis is brought to light. Based on the phase III trials, the PAD formulation may provide additional benefit to patients with mild to moderate plaque psoriasis in terms of efficacy, quality of life and favourable safety profile of the CAL/BDP PAD-cream stated Lars Iversen, Professor, Aarhus University Hospital.

The Danish Psoriasis Association is pleased to learn that this novel innovative treatment is made available to Danish psoriasis patients. The possibility to improve the quality of life and adherence to treatment are obviously very important features in topical treatment of psoriasis, said Lars Werner, Managing Director, Danish Psoriasis Association.

The deployment of Wynzora Cream in the rest of Europe is on track for 2022. Almirall started marketing the cream in the UK, Spain and Germany in February and expects to roll out in other European countries in the coming months once national marketing authorisations are granted. The product has received regulatory approval in 14 countries in Europe with the name Wynzora, and in Austria with the name Winxory.

"The launch of Wynzora Cream in Europe is on schedule and we are very pleased that Danish patients can now have this novel treatment option available to them. Initial feedback on the product in the UK, Germany and Spain is very positive and we are convinced that this innovative formulation will represent a substantial improvement for patients thanks to its galenic characteristics," said Gianfranco Nazzi, CEO of Almirall.

The Wynzora journey started more than a decade ago fuelled by our desire to meet the demand of patients through our innovative PAD Technology. It is a special feeling to see this new drug being made available also to patients in our home country, Denmark, while we continue the global roll-out., stated Jesper J. Lange, CEO of MC2 Therapeutics, developer of the PAD Technology and Wynzora Cream.

In February 2021, Almirall and MC2 Therapeutics entered into a strategic agreement under which MC2 Therapeutics granted Almirall exclusive European rights to commercialise Wynzora Cream for treatment of plaque psoriasis. Both companies announced the successful completion of a decentralised procedure in July 2021. The cream is also commercialized in the US by MC2 Therapeutics in collaboration with another company.

About pooled analysis of two randomized Phase III trials

WYNZORA (CAL/BDP PAD-cream) demonstrated superiority for all efficacy end points after 8 weeks of treatment. PGA treatment success for CAL/BDP PAD-cream (43.2%) was greater than CAL/BDP gel (31.9%; P<0.0001), the mean percent reduction in mPASI for CAL/BDP PAD-cream was 64.6% compared to 56.4% for CAL/BDP gel (P<0.0001), DLQI 0/1 was obtained by 43.8% in CAL/BDP PAD-cream versus 34.2% CAL/BDP gel (P=0.0005) and superior patient treatment convenience (PTCS) at Week 8 (40.4) was achieved with CAL/BDP PAD-cream compared to CAL/BDP gel (37.0; P<0.0001). There was no adverse drug reaction reported with a frequency of >1%, associated with CAL/BDP PAD-cream.4

About Almirall

Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patients needs through science to improve their lives. Our Noble Purpose is at the core of our work: Transform the patients' world by helping them realize their hopes and dreams for a healthy life. We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.

The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange and is a member of the IBEX35 (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.

For more information, please visit almirall.com

[ii] Prstegaard M, et al. Phase 3 trial demonstrates superior patient treatment convenience of MC2-01 calcipotriene plus betamethasone dipropionate cream compared to current topical suspension. J of Skin. 2020;4(5):s62

[iii] Stein Gold L, et al. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4): 420-425 doi:10.36849/JDD.5653.

[iv] Pinter A, et al. A pooled analysis of randomized, controlled, phase 3 trials investigating the efficacy and safety of a novel, fixed dose calcipotriene and betamethasone dipropionate cream for the topical treatment of plaque psoriasis. JEADV 2022; 36, 228236.

[v] World Health Organization. (2016). Global report on psoriasis. World Health Organization. https://apps.who.int/iris/handle/10665/204417

[vi] ParisiR,IskandarI Y K,KontopantelisE,AugustinM,GriffithsC E M,AshcroftD Met al.National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling studyBMJ2020;369:m1590doi:10.1136/bmj.m1590

[vii] National Psoriasis Foundation 2008 Survey Snapshot. Available from: PTT-24087-quality-of-life-issues-and-measurement-in-patients-with-psor (researchgate.net)

[viii] Armstrong AW, Schupp C, Wu J, et al. PLoS One. 2012;7(12):e52935;

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Almirall launches the innovative Wynzora cream in Denmark for the treatment of mild to moderate plaque psoriasis including scalp in adults[i] -...

A skin rash is an irritated or swollen area of skin and is often a symptom of other medical issues, such as allergies or substance intolerances. Affected areas may redden, itch, cause pain, blister or become raw. Skin rashes can appear quickly or over time, and while most will disappear quickly, some rashes may need long-term treatment if symptoms persist.

Though there are many types of skin rashes, below are some of the most common.

Eczema is a very common skin rash that causes swelling and may involve dryness, itching, scaly patches, infections and blisters. Eczema occurs in newborns, children and adults, and it affects more than 31 million people in the U.S., according to the National Eczema Association. This skin condition can present in many forms, including:

A number of factors contribute to eczema, among them being a persons environment and genetics. In most cases of eczema, an environmental factor triggers an immune response reaction, causing inflammation and eczema symptoms in the skin. This instance is often referred to as a flare up.

Atopic dermatitis is a common form of skin rash and the most common type of eczema. It can affect people of all age groups, from newborns to seniors. This type of skin rash is caused by an overreaction of the immune system to small irritants.

Atopic dermatitis is most common in children, with some reports saying close to 25% of children in the U.S. may have the disease, says Joshua Grosshandler, an Ohio-based dermatologist and fellow of the American Academy of Dermatology. All races can be affected but, in the U.S., there seems to be a higher number of African Americans and Asians than Caucasians.

Dr. Grosshandler explains that atopic dermatitis typically affects those with an atopic diathesis, or a predisposition to seasonal allergies, asthma and food allergies. Atopic dermatitis is a complex disease and is not fully understood.

Research suggests that family history of atopic dermatitis, food allergies, seasonal allergies, asthma, the immune system and environment all likely have a role in causing atopic dermatitis, says Dr. Grosshandler. Atopic dermatitis is a chronic potential lifelong condition and cannot be cured, so the goal of treatment is to control the condition, which includes reducing flares, decreasing symptoms like itch and improving the appearance of the skin.

A variety of medications and skin care routines can be used to help control symptoms, according to Dr. Grosshandler, including:

If youve ever gone hiking only to come home itching and scratching around your ankles, elbows or arms, you may have experienced contact dermatitisirritation or inflammation caused by coming into contact with an allergen or substance like poison ivy, poison oak or another external factor.

Contact dermatitis refers to a group of skin conditions for which the rash is due to direct contact with a causative agent either resulting in the irritation of the skin or an allergic reaction, says Dr. Grosshandler. The two main types are allergic contact dermatitis and irritant contact dermatitis.

Allergic contact dermatitis refers to a skin rash that appears as a delayed allergic reaction. This type of rash may appear one to two days after the skin is exposed to an allergen, such as poison ivy.

Irritant contact dermatitis refers to when skin cells are damaged due to exposure to an irritating substance. These reactions make up nearly 80% of all contact dermatitis cases, according to the National Eczema Association.

Both types of contact dermatitis can develop in anyone, although there are some groups that have a higher risk, such as those with atopic dermatitis, adds Dr. Grosshandler. Some allergens known to cause the condition include nickel, urushiol (the oil in poison ivy, poison oak and poison sumac), fragrance and latex.

Symptoms of contact dermatitis are often itchy, bumpy or flaky skin around the affected area. More severe cases can result in oozing blisters and heavy swelling. Symptoms may also cause disruptions in sleep and day-to-day activities due to discomfort.

To treat contact dermatitis:

Dermatologists may also prescribe steroids to help address itching and accompanying symptoms. In both allergic and irritant cases of contact dermatitis, its important to know and avoid the substance that causes the reaction. For severe allergic reactions, contact your health care provider.

Rosacea is very common in the U.S., with reports of 14 million people affected, according to the American Academy of Dermatology Association. It typically occurs in individuals between 30 and 50 years of age, with women being more likely to be affected than men.

There are four types of rosacea:

Fair-skinned individuals with light hair, light eyes and a Northern European ancestry have the classic background for rosacea, but it can affect those of all skin colors and genetic backgrounds, says Dr. Grosshandler.

The exact cause of rosacea is unknown, but there are multiple theories that involve genetics, environmental factors, vascular changes, inflammation and the immune system, explains Dr. Grosshandler. Sun exposure, for example, can cause the symptoms to intensify. Untreated rosacea tends to worsen over time.

While there isnt a cure for rosacea, there are different approaches to help manage the symptoms. Common rosacea triggers to consider avoiding include:

Medication can also be used to help treat rosacea. Prescription medications [to treat rosacea] include topical metronidazole, topical sodium sulfacetamide sulfur, topical ivermectin, topical azelaic acid, topical tetracycline, topical oxymetazoline, oral tetracycline antibiotics and vascular lasers such as the PDL, says Dr. Grosshandler. He also suggests implementing a consistent skin care routine with sunscreen, gentle cleansers and moisturizers to help manage outbreaks.

Psoriasisa type of rash identified by the itchy, red, scaly texture it creates on skinis thought to be caused by an autoimmune disorder, and it can follow a viral infection such as strep throat. However, the underlying cause of psoriasis is still unknown. If left untreated, psoriasis can worsen and become very painful.

Psoriasis is a common skin condition with approximately 2% of the population affected, says Dr. Grosshandler. Psoriasis can start at any age, but ages 15 to 25 and 50 to 60 are two peaks to see it present.

There are several types of psoriasis, according to the National Institute of Arthritis and Musculoskeletal Diseases.

Much like eczema, experts think psoriasis may be caused by a mixture of geneticspeople with the condition tend to have relatives who also suffer from psoriasisand environmental triggers. Mental health problems, being overweight, infection and some medications are also known triggers of psoriasis.

Medicinal treatment options for psoriasis include topical steroids, topical vitamin D creams, methotrexate (an immune suppressor used to slow the growth and division of cells), retinoids, biologic response monitors (injectable medications used to block, decrease or stop inflammation) Phosphodiesterase 4 (PDE4) inhibitors (used to suppress rapid cell turnover and inflammation) and immunosuppressants, among others.

Phototherapythe use of ultraviolet (UV) light on the affected area of skinis a treatment method typically used when large areas of the body are affected. This treatment can be offered in a doctors office or, if prescribed a proper UV light, at home.

While some rashes are not harmful and can be treated with gentle washing, others can be more severe and spread at rapid rates. If you experience skin rash symptoms, speak with your health care provider to discuss proper diagnosis and treatment.

Find a dermatologist near you

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Your Guide To Types Of Skin Rashes - Forbes