Study to Enroll Approximately 400 Patients With Moderate-to-Severe Acne Vulgaris
MENLO PARK, Calif., April 9, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (Nasdaq:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the initial dosing of the first patient in a Phase 2b dose-ranging trial for DRM01 in patients with facial acne vulgaris. The randomized, multi-center, double-blind, parallel-group, vehicle-controlled study is designed to assess the safety and efficacy of DRM01 compared to vehicle. The goal of the study is to establish the optimal dose for a potential Phase 3 program.
"This study marks an important milestone for Dermira, DRM01 and, we believe, patients suffering from acne," stated Tom Wiggans, chairman and chief executive officer of Dermira. "We are pleased with the progress of our DRM01 program and the potential that it holds as a novel treatment for the millions of acne patients who have long been underserved by available therapies. Our Phase 2a trial demonstrated clinically meaningful and statistically significant improvements in patients with moderate-to-severe acne across all primary efficacy endpoints, and this dose-ranging trial will provide us with the additional data needed to design a potential Phase 3 program. We expect to announce topline data from this Phase 2b study in the first half of 2016."
In the Phase 2b trial, approximately 400 adult patients with moderate-to-severe facial acne vulgaris will be randomized into five separate arms evaluating different DRM01 dosing regimens compared to vehicle. Approximately 300 patients will receive DRM01, and approximately 100 will receive vehicle. Consistent with the preceding Phase 2a trial and in accordance with the published U.S. Food and Drug Administration (FDA) draft guidance for the development of acne drugs, the primary endpoints are the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point Investigator's Global Assessment (IGA) score. Each endpoint will be measured at the end of the 12-week treatment period. The trial will be conducted at approximately 30 sites in the U.S. and Canada. Pending the successful completion of the Phase 2b trial and all applicable non-clinical work, Dermira expects to include both adult and adolescent patients in its Phase 3 program.
DRM01 is a novel, topical, small-molecule sebum inhibitor 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 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 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 DRM01 mechanism of action, the interpretation of the Phase 2a clinical results, enrollment of the Phase 2b clinical trial, when the results of the Phase 2b trial will be available and the design of any Phase 3 program. 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 outcomes of our clinical trials, our dependence on third-party clinical research organizations, manufacturers and suppliers, regulatory compliance with respect to the design and implementation of our clinical trials, our ability to obtain regulatory approval for our product candidates, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the risks set forth in Part I, Item 1A, "Risk Factors" in the Company's Annual Report on Form 10-K 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.
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