Keratosis, Seborrheic

- 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 .

0.8% SM-030 topical gel achieved safety and efficacy endpoints in a Phase 2 trial for solar lentigos and photoinduced pigmentation. The study enrolled two groups of subjects: 1) a group of subjects with solar lentigos treated with open label 0.8% SM-030 gel and 2) a randomized group of healthy subjects that received either 0.8% SM-030 gel, 4% hydroquinone cream, or vehicle gel applied to an area of sun exposed skin (dorsum of the hand) and a sun protected area (upper inner arm) Solar lentigos results: 100% of subjects treated with SM-030 applied to the entire dorsal hand twice-daily (BID) for 12 weeks achieved at least an IDGA of -1 and 27% achieved an IDGA of -2. Additionally, SM-030 demonstrated a statistically significant (p<0.0001) decrease in pigmentation on the treatment side compared to the contralateral untreated side as measured by colorimetry. Healthy volunteers: SM-030 applied to the entire dorsal hand (sun exposed) twice-daily (BID) for 12 weeks achieved greater efficacy than 4% hydroquinone in the proportion of subjects that obtained an Investigator Dynamic Global Assessment (IDGA) score of -1 (85% vs 75%) and -2 (30% vs 20%). There was no change in the pigmentation of the treated sun protected upper inner arm. BOSTON--(BUSINESS WIRE)-- DermBiont, Inc., a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of dermatological indications, today announced positive data from its Phase 2 trial with 0.8% SM-030 gel, a product under development capable of regulating pigmentation by controlling the formation of new melanin. Disorders of hyperpigmentation, such as melasma, photoinduced hyperpigmentation, and solar lentigos (lentigines), are common skin conditions affecting between 5% and 30% of the general population and are caused by an over production or irregular dispersion of epidermal melanin. There is no existing product that effectively and safely specifically inhibits the production of excess epidermal melanin. Tyrosinase, the key enzyme in the melanin synthetic pathway, requires phosphorylation by PKCβ for activity. SM-030 is a first-in-class selective and potent topical PKCβ inhibitor designed to inhibit PKCβ to reduce the production of excess epidermal melanin. DermBiont’s Phase 2 trial with SM-030 was conducted with two different groups of subjects. The first treatment group was an open-label within-subject bilateral-comparison group in 15 subjects with at least four solar lentigos on each dorsal hand treated twice-daily (BID) on one dorsal hand for 12 weeks with 0.8% SM-030 gel. The contralateral hand was untreated. The second group treated consisted of a group of 60 healthy volunteer subjects with Fitzpatrick Skin Type IV or V who were randomized 1:1:1 to receive either 0.8% SM-030 gel, vehicle gel, or 4% hydroquinone cream (an active comparator) applied to the dorsum of the hand (sun exposed skin) and upper inner arm (sun protected skin) with the contralateral hand and arm serving as untreated controls. Evaluations were observer blinded. Efficacy Analysis: Subjects in both groups (solar lentigos subjects and normal healthy volunteers) were assessed by way of the Investigator Dynamic Global Assessment (IDGA) Score at week 12. The IDGA score is a numerical score based on physician scoring of the pigmentation in the area of test article application relative to the untreated control site. The IDGA score ranges from -3 to +3 defined as markedly less pigmentation than the untreated control site (IDGA = -3); moderately less pigmentation than the untreated control site (IDGA = -2); slightly less pigmentation than the untreated control site (IDGA = -1); similar pigmentation to the untreated control site (IDGA=0); slightly more pigmentation than the untreated control site (IDGA = 1); moderately more pigmentation than the untreated control site (IDGA = 2); or markedly more pigmentation than the untreated control site (IDGA = 3). The Melanin index measured by colorimeter, defined by L* and ITA (degrees) calculations was also evaluated at each visit using a non-invasive biophysical measurement with a colorimeter (Chromometer CM-700: Konica-Minolta, Osaka, Japan). Results: Solar Lentigos Open Label Subjects: on the dorsal hand with the treated lentigos, 100% of subjects (n=15) achieved either an IDGA of –2 (moderately less pigment) or –1 (slightly less pigment) with 27% (n=4) achieving an IDGA of –2. There was also a statistically significant difference between the change in colorimetry from screening readings (p<0.0001) between treated and untreated lentigos at Week 12. Healthy Volunteer Randomized Subjects: on the sun exposed dorsal hand, 85% of subjects treated with 0.8% SM-030 gel, 75% with 4% hydroquinone, and 35% with vehicle gel achieved an IDGA score of –1 or less (p<0.01 comparing 0.8% SM-030 vs. vehicle). 30% of subjects treated with 0.8% SM-030 gel, 20% with 4% hydroquinone, and 0% with vehicle gel achieved an IDGA score of –2 or less (p<0.05 comparing 0.8% SM-030 vs. vehicle). There were no observed changes in the sun protected upper inner arm. All Subjects: The treatment was well tolerated, with 99% of safety observations having no local tolerability reactions. Any local tolerability reactions that occurred were all mild in nature, transient, and resolved without sequelae. There were no serious adverse events. “The data seen in this Phase 2 trial of SM-030 is highly encouraging as we have demonstrated IDGA improvement as well as a clear separation from placebo from baseline to the end of treatment,” stated Karl Beutner, M.D., Ph.D., CEO, and Co-Founder of DermBiont. “The existing options for treating hyperpigmentation lack sufficient efficacy, safety, and tolerability, and we believe that the successful development of SM-030 could bridge this gap and provide patients with an alternative treatment option that is safe for long-term use and very well tolerated amongst patients.” Based on positive results from this initial Phase 2 trial with 0.8% SM-030 gel, DermBiont plans to commence a 140 subject double-blind placebo-controlled trial treating melasma with 0.8% SM-030 topical gel in the second half of 2023. Nichola Eliovits, Co-Founder and Chief Business Officer at DermBiont, added, “The results of this initial trial are particularly exciting for melasma patients who currently treat dermal melanin with lasers but do not have any option to inhibit excess production of epidermal melanin, the root cause of patients’ melasma. SM-030 will efficaciously and safely inhibit excess production of epidermal melanin that leads to hyperpigmentation, resulting in monochromatic skin while providing desirable results to patients without the hypopigmentation side effects or the array of safety concerns associated with current treatments, including hydroquinone which is toxic to melanocytes and has been banned as a monotherapy at both 2% (OTC) and 4% (Rx) concentrations by the FDA.” About SM-030 PKCβ has the ability to increase melanin production by phosphorylating and increasing the activity of tyrosinase, which is the key and final enzyme in the melanin synthetic pathway. SM-030 is a first-in-class selective and potent topical PKCβ inhibitor intended to reduce the production of epidermal melanin. 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 diseases. The company aims to impact the root causes of skin diseases through the development of targeted small molecule therapeutics with well-defined mechanisms of action and biotherapeutics that repair an imbalance of the microbiome. The company’s targeted topical therapeutics pipeline includes two lead assets: SM-020 for the treatment of seborrheic keratosis and SM-030 for the treatment of hyperpigmentation disorders of the skin. For more information, please visit .