MENLO PARK, Calif., May 11, 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 that preclinical data for the DRM01 acne program will be presented in an oral presentation during the Society for Investigative Dermatology 75th Annual Meeting (SID), May 11-14, in Scottsdale, Arizona. The results of the DRM01 Phase 2b clinical trial will not be included as part of this presentation.
“The preclinical data being presented at SID will contribute to the growing body of preclinical and clinical data for DRM01 as a potential treatment option for patients living with acne,” said Eugene A. Bauer, M.D., chief medical officer of Dermira. “Our goal is to transform the way dermatologic diseases are treated so that patients are able to live their lives unencumbered by various skin conditions.”
The data will be presented in an oral presentation:
Title: DRM01, a novel, topical sebum inhibitor for the treatment of acne
Date and Time: May 14, 2016 from 12:30-3:00 p.m. MST
Abstract Final ID: 528
Session Order: CM14-04
DRM01 is a novel, small molecule designed to inhibit sebum production following topical application in development for the treatment of acne. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect in the development of acne that is not addressed by available topical therapies. DRM01 is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids.
Dermira recently announced positive topline results from a Phase 2b dose-ranging clinical trial for DRM01 in patients with facial acne vulgaris. Based on these results, Dermira plans to initiate a Phase 3 program to evaluate the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients. The initiation of this program is targeted for the first half of 2017, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
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 (excessive underarm sweating); and DRM01, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
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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 goal of delivering new therapies for patients with dermatologic diseases; the use of DRM01 as a safe and effective treatment for acne; the timing and initiation of a Phase 3 program for DRM01; and the prospective end-of-Phase 2 meeting with the FDA. 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 our anticipated end-of-Phase 2 meeting with the FDA for DRM01; 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 our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings we make with the SEC 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.
Senior Director, Head of Corporate Communications
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl