Keratosis, Seborrheic

BOSTON--( BUSINESS WIRE )-- DermBiont , a clinical-stage biotechnology company that is advancing first-in-class topical therapeutics to address patient needs in rare disease oncology and aesthetic dermatology, today announced positive initial data from its ongoing open label, multi-center Phase 2a study for the treatment of basal cell carcinoma (BCC). As a result, DermBiont has reprioritized SM-020, a first-in-class, patient-applied, and topical kinase inhibitor, for the development of two lead orphan disease oncology indications: treatment of locally advanced basal cell carcinoma (laBCC) and prevention of BCC in Gorlin Syndrome patients. DermBiont’s Phase 2a open-label trial is actively enrolling and treating up to 30 subjects with one to five superficial, nodular, or infiltrating primary BCCs. Lesions are being treated with SM-020 1% gel BID (twice daily) for 28 days, with the primary endpoint based on percent change from baseline in greatest tumor diameter at week 6. The safety of the drug product is being evaluated based on frequency of adverse events (AEs) and application site reactions (ASRs). At the time of this release, seven subjects with a total of nine BCCs (1 superficial, 4 nodular, and 4 infiltrating) have been treated and show a prompt (within days of starting treatment) and robust clinical response to the application of SM-020 1% gel, clearly demonstrating the disease modifying potential of SM-020. All nine tumors have also demonstrated a partial or total reduction in clinically visible tumor. Dr. Karl Beutner, M.D., Ph.D., and CEO of DermBiont said: “We are excited about these early results in BCC and the potential for a topical product for the treatment of laBCC and the prevention of BCCs in Gorlin Syndrome. An effective topical treatment would be welcomed by patients with laBCC given the limitations and side effects of the currently approved oral hedgehog inhibitors, while also providing patients with Gorlin Syndrome with an alternative to expensive and painful surgical procedures to remove chronic BCCs that result in significant scarring, require post-operative wound care, and lead to significant down time.” SM-020 has been well tolerated to date with no drug-related adverse events and only rare and transient primarily mild-to-moderate severity application site reactions. The same drug product has also been shown to be extremely well tolerated by subjects with seborrheic keratoses (SK), having been administered by over 100 subjects with SKs twice daily for at least 28 days in prior clinical trials. Emma Taylor, M.D. and Chief Medical Officer at DermBiont, added: “SM-020 in vitro is highly potent at killing BCC cells and has a well-defined mechanism of action that hits established tumorigenesis pathways known to be the cause of BCCs, so the robust response that we are seeing in the clinic is not surprising.” Basal Cell Carcinoma is the most common cancer with over three million cases annually in the United States alone. A BCC that is at least 10mm in diameter and that has either failed or is not appropriate for conventional treatment is considered a laBCC. In the United States, over 10,000 individuals suffer from laBCC annually, at least 10,000 individuals suffer from Gorlin Syndrome, and more than 30,000 people suffer from high frequency sporadic BCC, with tens of thousands of individuals being diagnosed with multiple basal cell carcinomas annually. In parallel to ongoing pivotal trial-enabling nonclinical and CMC scale-up work, DermBiont plans to seek Orphan Drug and Fast Track Designations for the treatment of laBCC and the prevention of BCC in patients with Gorlin Syndrome, to be followed by pivotal trials in two orphan indications for the approval of SM-020 for treatment of laBCC and prevention of BCC in Gorlin Syndrome patients. Following the reprioritization of SM-020 for laBCC and Gorlin Syndrome, Dermbiont is evaluating options for its SK program. About DermBiont DermBiont is a clinical-stage biotechnology company advancing two first-in-class topical therapeutics with well-defined mechanisms of action to address patient needs in rare disease oncology and aesthetic dermatology. SM-020 for the treatment of laBCC and prevention of BCC in Gorlin Syndrome, and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin. For more information, please visit www.dermbiont.com .

- 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas - - 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete clearance of the target plaque psoriasis lesion in the head and neck region – - 96.2% of patients achieved ≥75% improvement in Psoriasis Area and Severity Index (PASI75) of the head and neck region at Week 12 - - 70% of the adult patients achieved the widely followed standard of improvement in itch as measured by the Peak Pruritis-Numeric Rating Scale (PP-NRS) (head and neck region) of ≥ 4 points at Week 12, with some patients achieving this meaningful reduction in itch as early as Week 1 - - 96.7% of patients strongly agreed or agreed that VTAMA cream quickly absorbs and 93.3% of subjects strongly agreed or agreed that VTAMA cream was not greasy, including hair-bearing areas such as the scalp - - No new safety signals were observed over 12 weeks - LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)-- Dermavant Sciences Inc., a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its Phase 4, open-label clinical trial of VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in the head and neck region in adults (N=31). “Up to 80% of patients with plaque psoriasis experience scalp psoriasis, making it one of the most affected areas of the body. In this Phase 4 trial, a majority of the adult patients suffered from scalp psoriasis, making the outcomes from this trial significant, as they further reinforce the efficacy, safety, tolerability, and cosmetic elegance of VTAMA cream even when used in hair bearing areas such as the head and neck region,” said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. “The Phase 3 PSOARING studies and the Phase 4, open-label, intertriginous plaque psoriasis study combined with the Phase 4, open-label, head and neck data announced today, highlight the versatility of VTAMA cream, an efficacious, safe and well tolerated, non-steroidal treatment option for plaque psoriasis in all affected areas of the body.” This Phase 4, open-label study expands the body of data for VTAMA cream in adult plaque psoriasis. In the two 12-week Phase 3 pivotal studies (PSOARING 1 and 2; N=1025), VTAMA cream demonstrated a Physician Global Assessment (PGA) success rate* of 36% and 40% for adult patients with plaque psoriasis versus 6% for patients on vehicle at Week 12, respectively. DMVT-505-4002 (NCT05789576) was a Phase 4, open-label multi-center study to investigate the efficacy and safety of VTAMA (tapinarof) cream, 1% for the treatment of adults with plaque psoriasis specifically in the head and neck region. The efficacy of VTAMA cream was assessed using a PGA evaluation of a target plaque psoriasis lesion in the head and neck region, Scalp n=18 (58.1%), Face n=11 (35.5%) and Neck n=2 (6.5%) identified at baseline. The trial enrolled 31 participants with mild, moderate, and severe head and neck plaque psoriasis (tPGA score ≥2) aged 18 years or older at 8 sites across the U.S. Patients received VTAMA cream once daily for 12 weeks with a follow up one week after study completion. Safety and tolerability were assessed by visit based on adverse events and local tolerability scores using the investigator-assessed Local Tolerability Scale (LTS) of the head and neck region and a Patient Satisfaction Questionnaire (PSQ) that was designed to assess patients’ satisfaction with VTAMA cream’s efficacy, formulation elegance, application ease, impact on daily life, and preference versus prior therapies. The primary endpoint of the study was the proportion of adult patients who achieved a tPGA score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12 (tPGA Success). The secondary endpoint of the study was the time to achieve tPGA Success. Additional exploratory endpoints of the study included ≥75% improvement in PASI, change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS), ≥4point reduction in PP-NRS, and improvement in DLQI. Efficacy and PP-NRS assessments were specific to the head and neck region. Phase 4 Results Primary and Secondary Endpoints VTAMA cream reinforced strong efficacy for the treatment of head and neck plaque psoriasis (PsO), with 88.5% of adult patients (n=23/26) achieving a tPGA Success score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, the primary endpoint of the study. VTAMA cream showed a rapid onset of efficacy with tPGA Success achieved as early as Week 1 in some patients, with a median time of approximately 4 weeks, the secondary endpoint of the study. Additional Endpoints At Week 12, 80.8% (n=21/26) of adult patients achieved complete clearance of the target lesion (tPGA=0) which was observed as early as Week 1 and with a median time of 8 weeks. At Week 12, 96.2% (n=25/26) of patients achieved PASI75 (≥75% reduction in PASI of the head and neck region), with achievement observed as early as Week 1. Onset of itch relief was apparent as early as Week 1 and increased over time with 70% (n=14/20) of patients achieving a clinically meaningful ≥4-point improvement in PP-NRS at Week 12. Substantial and clinically meaningful improvement in quality of life, as indicated by a 4-point improvement in DLQI, was achieved as early as Week 1 with further improvement out to Week 12. As indicated on the Patient Satisfaction Questionnaire, 93.3% (n=28/30) of subjects strongly agreed or agreed that VTAMA cream was not greasy, 86.7% (n=26/30) of subjects strongly agreed or agreed that VTAMA cream was easy to apply, and 96.7% (n=29/30) of subjects strongly agreed or agreed that VTAMA cream absorbs quickly. Safety and Tolerability VTAMA cream was well tolerated with no new safety signals. The most common adverse reactions (incidence ≥ 5%) in subjects treated with VTAMA cream were folliculitis, contact dermatitis, headache, sinusitis, and seborrheic keratosis. “Plaque psoriasis is a chronic condition with a significant negative impact on patients’ quality of life. The scalp region, in particular, is one of the most difficult areas to treat. Many currently available treatment options fail to offer sustained long-term relief due to lack of practical applicability to certain body areas and limitations on the duration of use,” said G. Michael Lewitt, MD, FAAD, Board-Certified Dermatologist, Illinois Dermatology Institute. “The impressive levels of efficacy achieved by VTAMA cream in the open-label trial, where 80% of adult patients achieved complete clearance of the target lesion, is highly encouraging for both patients with plaque psoriasis and their healthcare providers. Importantly, 58% of patients enrolled in the trial had a target plaque psoriasis lesion in the scalp region, and as assessed by both the investigators and the patients in the trial, VTAMA cream demonstrated favorable tolerability even when applied in hair bearing affected areas; making it a versatile and cosmetically elegant treatment option for plaque psoriasis that can be used anywhere on the affected body areas, including the most sensitive areas as well the scalp, head, and neck areas.” On May 24, 2022, Dermavant announced that the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for plaque psoriasis in the U.S. in more than 25 years. VTAMA cream is approved for mild, moderate, and severe plaque psoriasis - with no label safety warnings or precautions, restrictions on duration of use or body surface area. On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adultsi and to date has over 250,000 prescriptions written by over 12,000 unique prescribers†. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About Psoriasis Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease — meaning that the body’s immune system targets and attacks its own cells. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80% to 90% of people with psoriasis. In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scales. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scales. The scales can be itchy, painful, and disfiguring. Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50 to 60 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person’s quality of life and psychological health. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children as young as 2 years old and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. For more information, please visit and follow us on X (@dermavant) and LinkedIn (Dermavant Sciences). *PGA success: PGA score of 0 or 1 and ≥2-grade improvement from baseline at Week 12. iIQVIA National Prescription Audit (NPA) for the 3-month period ending 11/24/2023, reflecting estimates of real-world activity. All rights reserved. †IQVIA NPA for the period 5/20/22 to 11/24/2023, reflecting estimates of real-world activity. All rights reserved. ©2023 Dermavant Sciences, Inc. All Rights Reserved. All trademarks are the property of Dermavant Sciences, GmbH.

- Series B led by Double Point Ventures with major support from Viking Global Investors as well as other new and existing investors - - A combined $27.1 million Series B first close and $8.1 million in converting outstanding notes funds the company’s two assets in development, SM-020 for the treatment of seborrheic keratoses and SM-030 for the treatment of melasma, through end of Phase 2 meetings with FDA and commencement of Phase 3 trials - BOSTON--(BUSINESS WIRE)-- DermBiont, Inc., a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of dermatological indications, today announced a $35.2 million Series B financing, including a $27.1 million Series B first close and $8.1 million in converting outstanding notes. Proceeds will be used to advance two drugs in development, SM-020, a topical novel AKT kinase inhibitor for the treatment of seborrheic keratoses (SKs), and SM-030, a topical novel PKC-beta inhibitor for the treatment of melasma and other hyperpigmentation disorders of the skin. The Series B was led by new institutional investor, Double Point Ventures, and includes continued support from Viking Global Investors, Civilization Ventures, Olive Tree Capital, and others. Concurrent with the financing, Daniel Yadegar, M.D., Managing Partner at Double Point Ventures, joined DermBiont’s board of directors, adding, “I am excited to be working closely with DermBiont’s team to advance two products, one for the treatment of seborrheic keratoses and the other for the treatment of melasma, two of the most frequently diagnosed skin diseases by dermatologists. These products prioritize the patient experience by addressing the root cause of both diseases with excellent efficacy, safety, and tolerability. Physicians understand that patients with SKs and hyperpigmentation disorders of the skin are seeking effective, safe, and well-tolerated topical treatment options compared with existing ablative surgical procedures for treating SKs or ineffective lasers with frequent recurrence or unsafe toxic chemicals with very low efficacy like hydroquinone for treating melasma.” The proceeds from the Series B financing will be used to advance the clinical development of SM-020 and SM-030. They are expected to fund the company through end of its Phase 2 meetings with the U.S. Food and Drug Administration (FDA), which are expected in the second half of 2024 for both programs. In the next twelve months, DermBiont will commence enrollment for three planned seborrheic keratoses clinical trials and one melasma trial as follows: Phase 2b randomized, double-blind, vehicle-controlled clinical trial in 60 subjects with seborrheic keratoses treated with SM-020 gel 1% or vehicle twice daily for 28 days. Phase 2b open label clinical trial in 10 subjects with DPN (Dermatosis Papulosa Nigra) treated with SM-020 gel 1% twice daily for 28 days. Phase 2 open label clinical trial extension in 25 additional subjects with seborrheic keratoses treated with SM-020 gel 0.1% or SM-020 gel 1% daily or twice daily for 28 to 56 days. Phase 2b randomized, observer-blinded, placebo-controlled clinical trial in 138 subjects with melasma treated with SM-030 gel 0.64%, SM-030 gel 0.08%, or placebo gel twice daily for 12 weeks “The addition of Double Point Ventures as a major backer alongside continued financial and strategic support from Viking Global Investors and other investors allows us to accelerate the development of our pipeline of novel topical therapeutics for the treatment of the number one and number three most frequently diagnosed disorders of the skin by dermatologists in the US, seborrheic keratoses and hyperpigmentation, respectively,” stated Karl Beutner, M.D., Ph.D., Chief Executive Officer and Co-Founder of DermBiont. “This funding comes on the heels of our successful Phase 2 proof of concept trials, where SM-030 gel 0.64% achieved greater efficacy than 4% hydroquinone, and where over 80% of SKs responded to treatment with SM-020 gel 1.0% twice daily for 14 to 28 days and over 50% of SK lesions completely cleared in the most effective dosing regimen.” About DermBiont DermBiont’s mission is to become the world’s leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined mechanisms of action. The company’s targeted topical therapeutics pipeline includes two lead assets: SM-020 for the treatment of seborrheic keratoses and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin. For more information, please visit . About Double Point Ventures At Double Point Ventures, we see beyond today's treatments to envision tomorrow's cures. Our fund invests in revolutionary companies developing cutting-edge therapeutics, from gene therapies to precision medicines. While novel drugs are our focus, we also target innovative early revenue-stage diagnostic companies, medical device startups, digital health startups, and healthcare services providers catalyzing the future of healthcare. Backed by visionary investors, our mission is clear - fund the science superstars solving the medical mysteries of our time. By powering pioneering companies, we strive to bring groundbreaking treatments from bench to bedside. Double Point Ventures is led by Managing Partner, Daniel Yadegar, M.D. For more information, please visit .