BASEL, Switzerland, April 3, 2018 /PRNewswire/ — Dermavant Sciences, a biopharmaceutical company focused on developing innovative therapies for dermatologic conditions, today announced that it has expanded its pipeline by inlicensing an investigational drug for the treatment of multi-focal hyperhidrosis. It has also strengthened its management team through the appointment of David Rubenstein, M.D., Ph.D., as Chief Scientific Officer, Richard Peterson as Chief Financial Officer, Ariel D. Jasie as Chief Business & Strategy Officer, and Chris Van Tuyl as General Counsel.
“I am delighted to welcome David, Ric, Ariel, and Chris to our team and we look forward to advancing the development of a promising treatment for hyperhidrosis,” said Dr. Jacqualyn A. Fouse, Executive Chair of Dermavant. “I’m proud of the progress we’ve made in building a diverse pipeline and I look forward to continuing to build Dermavant into the industry leader in medical dermatology.”
Dermavant’s fifth drug in development will be RVT-504 (previously THVD-102), a potential systemic treatment for hyperhidrosis in-licensed from TheraVida, Inc. Dermavant has secured rights for development and commercialization; deal terms include an upfront payment, milestone payments, and royalties.
Dr. Rubenstein has joined Dermavant from GlaxoSmithKline Dermatology where he built an industry-leading dermatology drug development organization as Vice President, Discovery and Preclinical Development. Prior to GSK, he held academic roles at the University of North Carolina at Chapel Hill, most recently serving as the Louis C. Skinner Jr. Distinguished Professor of Dermatology. Dr. Rubenstein received his A.B. in Molecular Biology from Princeton University and his M.D. and Ph.D. from Duke University School of Medicine. He completed his dermatology residency and postdoctoral fellowship in dermatology and biology at UNC-Chapel Hill.
Mr. Peterson has joined Dermavant from Sienna Biopharmaceuticals where he served as Chief Financial Officer. Mr. Peterson has extensive experience in the dermatology space, previously serving as Chief Financial Officer of Novan and as Chief Financial Officer, Executive Vice President, and Treasurer of Medicis Pharmaceutical Corporation through the company’s $2.6 billion acquisition in 2012. Before joining Medicis in 1995, Mr. Peterson was a Senior Financial Auditor at PricewaterhouseCoopers LLP. He received his B.S. in Accounting from Arizona State University.
Mr. Jasie has joined Dermavant from Codiak BioSciences where he served as Chief Business Officer. Prior to Codiak, he served in various executive roles at Celgene Corporation, most recently as Executive Director for Strategy and Operations for the company’s Research & Early Development Group. Before joining Celgene, Mr. Jasie served as in-house counsel at Reliant Pharmaceuticals through the company’s $1.6 billion acquisition in 2007. He received his B.A. in History from the University of Maryland and his J.D. from Brooklyn Law School.
Mr. Van Tuyl has joined Dermavant from Sacks Tierney P.A., where he was a partner in the firm’s corporate practice group. He previously served as Corporate Secretary, Chief Compliance Officer, and Associate General Counsel at Rayonier, Inc., where he oversaw key aspects of the company’s multi-billion-dollar spinoff of its chemicals business in 2014, and as Associate General Counsel at Medicis Pharmaceuticals through the company’s $2.6 billion acquisition in 2012. Prior to joining Medicis, Mr. Van Tuyl was a corporate attorney at Squire Sanders & Dempsey LLP in Phoenix and Clifford Chance LLP in New York. He received his B.S. in Finance summa cum laude from Arizona State University and his J.D. from Duke University School of Law.
Hyperhidrosis consists of abnormal sweating beyond the amount necessary for thermal regulation. The most common form of the disorder is primary focal hyperhidrosis in which sweat glands in the hands, underarms, face, groin, and feet are chronically overactive in the absence of physical activity or an increase in temperature. Recent studies have suggested that this form of hyperhidrosis is primarily multi-focal, with approximately 80 percent of individuals experiencing excessive sweating at multiple locations on their bodies.1,2 Secondary hyperhidrosis refers to excessive sweating caused by another medical condition or as a side effect of a medication. In the United States alone it is estimated that there are over 15 million individuals suffering from hyperhidrosis.
RVT-504 is a combination of the muscarinic antagonist oxybutynin with the muscarinic agonist pilocarpine in a twice-daily oral formulation. RVT-504 uses proprietary technology to control the release and dosing of pilocarpine with the goal of reducing the frequency and severity of dry mouth and potentially other side effects associated with oxybutynin. In a completed Phase 2 clinical trial in primary focal hyperhidrosis, RVT-504 demonstrated statistically significant improvements from baseline relative to placebo on multiple endpoints including the Hyperhidrosis Disease Severity Scale, the Hyperhidrosis Visual Analog Scale, and the Hyperhidrosis Visual Quantification Scale. RVT-504 also demonstrated statistically significant reductions in the severity of dry mouth when compared to dosing with oxybutynin alone. RVT-504 is the only oral, systemically acting drug for primary focal hyperhidrosis currently in development.
About Dermavant Sciences
Dermavant Sciences is dedicated to developing and, upon regulatory approval, commercializing innovative therapies in medical dermatology. Dermavant currently has five investigational drugs in development: RVT-501, RVT-502, RVT-503, RVT-504, and RVT-201.
RVT-501 is a highly potent and selective topical phosphodiesterase-4 inhibitor being developed as a topical therapy for patients with mild-to-moderate atopic dermatitis. RVT-502 is a dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor being developed as a topical therapy for a variety of serious dermatologic conditions. RVT-503 is a preclinical asset being studied for the treatment of acne. RVT-504 is a combination of a muscarinic antagonist with a muscarinic agonist being developed as an oral 1 therapy for the treatment of hyperhidrosis. RVT-201 is a caspase-1 inhibitor that acts to inhibit the production of inflammatory cytokines and is being developed as a topical therapy for inflammatory skin diseases.
For more information, please visit dermavant.com.
1. Doolittle J, Walker P, Mills T, et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res (2016) 308:743.
2. Glaser DA, Ballard AM, Hunt NL, et al. Prevalence of multifocal primary hyperhidrosis and symptom severity over time: results of a targeted survey. Dermatol Surg (2016) 42:1347-1353.
Phase 2 Study Presented at Late-breaking Session during the 25th European Academy of Dermatology and Venereology Congress
October 03, 2016 07:00 AM Eastern Daylight Time
VIENNA, Austria–(BUSINESS WIRE)–Positive Phase 2 study results with THVD-102, a combination drug product for the treatment of primary focal hyperhidrosis, or excessive sweating, were presented on October 1, 2016 at the 25th European Academy of Dermatology and Venereology Congress, in Vienna, Austria. David M. Pariser, MD, a leading expert on hyperhidrosis and a founding board member of the International Hyperhidrosis Society presented the study results in the Late-Breaking Session.
The study evaluated the safety and efficacy as well as dry mouth of THVD-102 (oxybutynin 7.5mg plus pilocarpine 7.5mg) versus placebo and oxybutynin alone in subjects with primary focal hyperhidrosis (PFH). Subjects were randomized into 1 of 6 sequences of 3 study treatments (THVD-102, oxybutynin 7.5mg and placebo) in sequential 21-day double-blind crossover treatment periods, each preceded by a washout period of at least 7 days.
A total of 24 subjects were randomized and 19 completed all three crossovers. At baseline, mean Hyperhidrosis Disease Severity Scale (HDSS) score was 3.2 (scale, 1-4).
Changes from baseline to end of treatment in symptoms associated with PFH were statistically significant for both THVD-102 versus placebo and oxybutynin versus placebo as assessed by multiple measures including the HDSS, the Hyperhidrosis Visual Analog Scale (HHVAS) and the Hyperhidrosis Visual Quantification Scale (HHVQS). Beneficial trends for gravimetric measurements were also observed. There were no statistically significant differences between THVD-102 and oxybutynin in PFH efficacy.
Significantly fewer subjects receiving THVD-102 reported “moderate” or “severe” dry mouth while receiving THVD- 102 compared to oxybutynin and significantly more subjects categorized their dry mouth as “none” or “mild” while receiving THVD-102 compared to oxybutynin.
“A well-tolerated, oral treatment for hyperhidrosis would address an important unmet need for patients and physicians,” said Benjamin F. McGraw, III, PharmD, Chairman and CEO of TheraVida, Inc., which is developing THVD-102.
Hyperhidrosis can affect multiple areas including the underarms, the palms of hands, soles of feet, face and other areas. Current treatments, which include injections of botulinum toxin, are expensive, painful and are limited to affecting only localized areas of the body.
“Hyperhidrosis can significantly impair the social, occupational and emotional well-being of patients and current treatments are lacking in many ways. I’m very encouraged by these study results,” said Dr. Pariser.
THVD-102 is a combination drug product composed of a muscarinic antagonist (oxybutynin) and a muscarinic agonist (pilocarpine) in a twice daily, oral formulation for the treatment of primary focal hyperhidrosis. In multiple trials, oxybutynin has shown activity in hyperhidrosis but is rarely used due to poor patient tolerance, most commonly dry mouth. Pilocarpine counters the dry mouth caused by oxybutynin without interfering with the beneficial effect of oxybutynin when the two drugs are formulated together in a manner that is covered by the intellectual property of TheraVida, Inc.
About TheraVida, Inc.
TheraVida is a clinical stage pharmaceutical company dedicated to the development of new therapies to improve the lives of patients with hyperhidrosis. For more information, visit www.theravida.com.
Ben McGraw, +1 650-638-2335
TheraVida is dedicated to the development of new therapies to improve the lives of patients with hyperhidrosis