FDA Approves Sol-Gel Technologies’ and Galderma’s Epsolay for Rosacea
The FDA has approved Sol-Gel Technologies’ Epsolay, a proprietary cream formulation of benzoyl peroxide 5%, for the treatment of inflammatory lesions of rosacea in adults.
The benzoyl peroxide in Epsolay is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. The approval is supported by data from two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Epsolay compared to vehicle in people with inflammatory lesions of rosacea (N = 733). The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. Epsolay was more effective than vehicle cream on the co-primary efficacy endpoints starting from week four of treatment in both trials. With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70 percent by the end of both 12-week trials vs. 38-46 percent with vehicle. Nearly 50 percent of subjects were clear (IGA=0) or almost clear (IGA=1) at 12 weeks vs. 38-46 percent with placebo. Post-hoc analysis of lesion count and IGA success at Week 2 confirmed a significantly greater treatment effect for Epsolay relative to vehicle as early as Week 2. In the open-label extension, 73 percent of subjects were clear or almost clear at 52 weeks.
Sol-Gel has granted exclusive rights to commercialize Epsolay in the US to to Galderma Holding SA.
Neal Bhatia. MD, dermatologist at Therapeutics Clinical Research in San Diego, CA and Chief Medical Editor of Practical Dermatology® magazine commented, “There is poor adherence of my patients to current treatments for inflammatory rosacea and I look forward to being able to prescribe Epsolay to them, primarily because Epsolay has demonstrated outstanding and rapid efficacy results and also because Epsolay has been shown to be well tolerated, both of which are important factors to ensure patients’ satisfaction.”
Non-Invasive Gene Expression Profile Test Can Predict Response to Systemic Therapy in Patients with Inflammatory Skin Diseases
Castle Biosciences, Inc.’s non-invasive skin scraping technique produces sufficient ribonucleic acid (RNA) to assess reproducible gene expression for its inflammatory skin disease pipeline test, according to a poster was presented at the 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conference.
Castle is developing a gene expression profile (GEP) test, expected to launch by the end of 2025, to predict response to systemic therapy in patients with moderate to severe psoriasis, atopic dermatitis (AD) and related inflammatory skin conditions.
The study used quantitative real-time polymerase chain reaction (RT-PCR) to evaluate the gene expression of a standard gene set of samples collected by gently scraping affected and non-affected skin from 20 patients with AD and 20 patients with psoriasis from two dermatology centers in the US. Overall, the study determined that the non-invasive skin scraping technique produced sufficient RNA to assess reproducible gene expression needed to develop a gene expression profile for Castle’s inflammatory skin disease pipeline test.
In 2021, Castle initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test. The study currently has 52 committed sites and approximately 145 patients enrolled; initial validation and development data is expected in 2023.
Lilly’s Lebrikizumab + TCS Leads to Significant Improvements in AD Disease Severity
Atopic dermatitis patients taking lebrikizumab plus topical steroids showed significant improvements in disease severity, according to study results from the ADhere trial presented at the 4th Annual Revolutionizing Atopic Dermatitis (RAD) Conference.
At 16 weeks, 70 percent of patients with moderate to severe atopic dermatitis (AD) receiving lebrikizumab combined with standard-of-care topical corticosteroids (TCS) achieved at least 75 percent improvement in overall disease severity (EASI-75), the study found.
Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway. IL-13 plays the central role in Type 2 inflammation in AD. In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.
Lebrikizumab also showed improvements in itch, sleep interference, and quality of life when combined with TCS, compared to placebo plus TCS.
Among patients taking lebrikizumab plus TCS, 41 percent achieved clear or almost clear skin (IGA) at 16 weeks compared to 22 percent of patients taking placebo plus TCS. At 16 weeks, 70 percent of patients taking lebrikizumab plus TCS achieved an EASI-75 response compared to 42 percent taking placebo plus TCS. Differences between patients receiving lebrikizumab in combination with TCS and placebo with TCS were observed as early as four weeks for EASI-75.
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Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints including skin clearance and itching, interference of itch on sleep, and quality of life measures, compared to placebo with TCS.
Safety results were consistent with prior lebrikizumab studies in AD.
Arcutis Completes Enrollment in Phase 3 Trial of Topical Roflumilast Foam in Scalp and Body Psoriasis
Enrollment in Arcutis’ ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and adults with scalp and body psoriasis is complete, the company reports.
Roflumilast foam is a once-daily, topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor (roflumilast). The foam formulation was designed to treat all areas of the body, including the face and particularly hair-bearing areas such as the scalp.
Topline data is anticipated in late Q3/early Q4 2022. If successful, the company believes that this trial will provide sufficient basis to file a supplemental New Drug Application (sNDA) for roflumilast foam in scalp and body psoriasis.
San Francisco Dermatologist Advances Innovative Treatment on FDA Committee
The American Academy of Dermatology has named San Francisco board-certified dermatologist Kenneth Katz, MD, MSc, MSCE, FAAD as a Patient Care Hero for his work leading a national advisory committee at the FDA. The committee provides advice to FDA on new therapies to improve patients’ skin, hair, and nail conditions and other issues that come before FDA.
Dr. Katz serves as co-chair of the FDA’s Dermatologic and Ophthalmic Drug Advisory Committee, which meets on an ad hoc basis, at the request of FDA, and gives input to FDA on the safety and effectiveness new and innovative dermatologic medications and any other dermatology-related matter for which FDA feels advisory committee input would be useful.
“Practicing dermatologists on the committee provide real-world expertise since we treat countless skin, hair, and nail conditions every day and understand the implications for patients,” says Dr. Katz, a physician at Kaiser Permanente in San Francisco. “In some cases, dermatologists across the country can use new treatments to provide life-changing care.”
During his committee tenure, Dr. Katz has participated in evaluating an innovative and now commonly used psoriasis medication, recommending that an effective acne treatment be more accessible to patients, establishing safe timeline to test atopic dermatitis treatments in pediatric patients, and much more.
