Topline Results for Phase 3 ATMOS-1 and ATMOS-2 Clinical Trials Expected in 2Q 2016
MENLO PARK, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced the completion of patient enrollment in its Phase 3 ATMOS-1 and ATMOS-2 clinical trials for DRM04 in primary axillary hyperhidrosis (excessive underarm sweating). Based on enrollment completing ahead of schedule, Dermira now expects to announce topline efficacy and safety data for both of these trials during the second quarter of 2016, compared with previous guidance of mid-2016.
“Once again, we are delighted to announce the completion of patient enrollment, ahead of schedule, in a Dermira clinical program, this time for our two Phase 3 DRM04 pivotal clinical trials in hyperhidrosis,” stated Luis Peña, chief development officer of Dermira. “We continue to believe that DRM04, a topically administered anticholinergic, may provide an attractive therapeutic approach, if approved, relative to the currently available treatment options for patients suffering from hyperhidrosis. We look forward to sharing the results from our Phase 3 trials in the coming months.”
DRM04 Phase 3 Clinical Program
The DRM04 Phase 3 program is designed to assess the safety and efficacy of DRM04 to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The program consists of two pivotal studies, ATMOS-1 and ATMOS-2, to assess the safety and efficacy of DRM04 compared to vehicle and an open-label study, ARIDO, to assess the long-term safety of DRM04. The program is being conducted at approximately 50 trial sites in the U.S. and Germany.
The ATMOS-1 and ATMOS-2 studies are identical, randomized, double-blind, vehicle-controlled trials that collectively enrolled 697 adult and adolescent (ages nine and older) patients with primary axillary hyperhidrosis. In each of these trials, approximately two-thirds of the patients will receive DRM04 and approximately one-third of the patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only. The co-primary endpoints are the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company’s proprietary patient-reported outcome (PRO) instrument. Secondary efficacy endpoints include (1) the proportion of subjects who have at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and (2) the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Both the primary and secondary endpoints will be assessed at the end of the four-week treatment period.
Topline results from the ATMOS-1 and ATMOS-2 trials are now expected in the second quarter of 2016. In the open-label ARIDO study assessing the long-term safety of DRM04, patients from either of the ATMOS Phase 3 studies are permitted to continue to receive active treatment for up to an additional 44 weeks from the end of the 4-week treatment periods in the ATMOS studies. Pending the successful completion of these studies and other registration-enabling activities, Dermira expects to submit an NDA to the FDA in the second half of 2017.
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio includes three late-stage product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3 development for the treatment of primary axillary hyperhidrosis; and DRM01, in Phase 2b development for the treatment of acne vulgaris. 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, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 statements with respect to the successful completion of, and timing expectations for the receipt and announcement of topline efficacy and safety data from, the DRM04 Phase 3 studies; the use of DRM04 as a safe and effective treatment for hyperhidrosis; the description of the DRM04 Phase 3 studies; and the potential NDA submission to the FDA for DRM04 and the expected timing of such submission. 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 design, implementation and outcomes of our clinical trials; our dependence on third-party clinical research organizations, manufacturers and suppliers; our ability to obtain regulatory approval for our product candidates; and our ability to continue to stay in compliance with applicable laws and regulations. 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, you should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Report on Form 10-Q and other filings Dermira makes with the Securities and Exchange Commission from time to time. 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.
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl