Menlo Park, CA – Dermira, Inc. (NASDAQ: DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced positive Phase 2b study results for DRM04, its proprietary topical anticholinergic product, in patients with axillary hyperhidrosis, or excessive underarm sweating. Based on the results of this study (DRM04-HH02) and its first Phase 2b study (DRM04-HH01), Dermira plans to initiate a Phase 3 program for DRM04 in axillary hyperhidrosis in the second half of 2015, consistent with previous expectations and subject to an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA).
“We are extremely pleased with the progress of our DRM04 clinical development program and the promise DRM04 holds as a potential treatment for the millions of hyperhidrosis patients, who suffer from this debilitating condition, and the dermatologists who treat them,” stated Tom Wiggans, chairman and chief executive officer of Dermira. “We believe the positive results from our two completed Phase 2b studies, especially the treatment effect and tolerability profile we have observed, will support the advancement of DRM04 into Phase 3 clinical development in the second half of 2015.”
Dermira’s Phase 2 hyperhidrosis program included two randomized, double-blind, vehicle-controlled Phase 2b clinical trials in approximately 300 patients with severe, primary axillary hyperhidrosis. The first Phase 2b study (DRM04-HH01), completed in August 2014, demonstrated dose-dependent and, at certain doses, statistically significant reductions in the signs and symptoms of primary axillary hyperhidrosis in patients treated with a topical formulation of an anticholinergic agent that has been approved for systemic administration in other indications, referred to as the topical formulation of the reference agent. The results of the second Phase 2b study (DRM04-HH02) were consistent with the results of the previous Phase 2b study and now provide clinical experience with DRM04, Dermira’s proprietary product containing a novel form of the reference agent.
Study DRM04-HH02 Design and Results
Given the substantial clinical experience gained with the topical formulation of the reference agent in Study DRM04-HH01, Study DRM04-HH02 was designed to gain clinical experience with DRM04 prior to the initiation of Phase 3 development. Accordingly, Study DRM04-HH02 was not powered to demonstrate statistical significance. Study DRM04-HH02 was a randomized, double-blind, vehicle-controlled clinical trial assessing the efficacy, safety and pharmacokinetics of DRM04, the topical formulation of the reference agent, and vehicle in 105 patients with severe, primary axillary hyperhidrosis. Patients were randomized equally into five arms to receive DRM04 at one of two concentrations, a topical formulation at one of two concentrations of the reference agent, or vehicle only.
Patients enrolled in Study DRM04-HH02 were instructed to apply the study product to each axilla once daily for four weeks using wipes containing either drug product or vehicle only. Primary efficacy endpoints included the absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieved at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is a widely used patient-reported outcome tool which allows patients to rate the severity of their disease on a four-point scale. Each of these endpoints was assessed at the end of the four-week treatment period. The study also explored a new, proprietary patient-reported outcome instrument, the Axillary Sweating Daily Diary (ASDD), as a potential additional measure of disease severity.
The average reduction in sweat production from baseline to week four ranged from 67.7% to 79.8% (72.7 to 105.3 mg per five minutes) in patients in the two arms treated with DRM04, compared to 48.7% (53.9 mg per five minutes) in patients who received the vehicle only. The proportion of patients who achieved at least a two-grade improvement in HDSS score from baseline to week four ranged from 40.9% to 50.0% in patients in the two arms treated with DRM04, compared to 27.3% in patients who received the vehicle only. For patients in the two arms treated with the topical formulation of the reference agent, the results were consistent with those observed in Study DRM04-HH01. Overall, Study DRM04-HH02 met the company’s objectives and expectations. ASDD data, which are still being validated, demonstrated greater improvements in disease severity in all treatment arms than in the vehicle arm.
Consistent with previous experience in the DRM04-HH01 Phase 2b study, topical treatment was well tolerated with a low incidence of manageable side effects across the arms evaluated in Study DRM04-HH02. The most common adverse events reported were dry mouth, application site pain and headache. No treatment-related serious adverse events were reported.
Study DRM04-HH01 Design and Results
Study DRM04-HH01 was a randomized, double-blind, vehicle-controlled trial that enrolled 198 patients with severe, primary axillary hyperhidrosis. Patients were randomized equally into five arms to receive the topical formulation of the reference agent at one of four concentrations, including each of the concentrations evaluated in Study DRM04-HH02, or vehicle only for four weeks. The two primary efficacy endpoints evaluated in Study DRM04-HH01 were the same as those evaluated in Study DRM04-HH02. Study DRM04-HH01 demonstrated dose-dependent and, at certain doses, statistically significant improvements relative to vehicle in both of the primary efficacy endpoints.
Hyperhidrosis is a condition of excessive sweating beyond what is physiologically required to maintain normal thermal regulation. It can affect the axillae (underarms), palms of the hands, soles of the feet, face and other areas. In the United States, based on the most recent data available, the prevalence of hyperhidrosis was estimated in 2003 to be 2.8% of the population, or roughly 7.8 million people. According to published studies, approximately half of hyperhidrosis sufferers have axillary hyperhidrosis, and approximately one-third of axillary sufferers, or 1.3 million Americans, have severe disease that is barely tolerable and frequently interferes or is intolerable and always interferes with daily activities.
Dermira is a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients. Dermira’s portfolio of five product candidates targets significant market opportunities and includes three late‐stage product candidates, CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe plaque psoriasis; DRM04, a topical treatment for hyperhidrosis; and, DRM01, a topical sebum inhibitor for the treatment of acne. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including with respect to the final results of Study DRM04-HH02 and the expected initiation of Phase 3 clinical trials for DRM04. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the receipt and analysis of the results of the DRM04-HH02 study, the outcomes of our planned end-of-phase 2 meeting with the FDA, our dependence on third party clinical research organizations, manufacturers and suppliers, our ability to obtain regulatory approval for our product candidates, the costs of our development programs, our ability to obtain necessary additional capital, market acceptance of our potential products, our ability to develop and maintain collaborations and license products and intellectual property, the impact of competitive products and therapies including generics and biosimilars, our ability to manage the growth and complexity of our organization, our ability to maintain, protect and enhance our intellectual property, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the risks set forth in Part II, Item 1A, “Risk Factors” in the Company’s Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.