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 the presentation of new data for DRM01, a novel, topical sebum inhibitor in development for the treatment of acne. The results from a study in Yorkshire pigs demonstrated that DRM01 penetrates the skin in a dose- and formulation-dependent manner and accumulates in the sebaceous glands. These animals have skin morphology and physiology similar to human skin, including well-developed sebaceous glands, suggesting that the compound may effectively localize at the site of increased sebum production in the skin of patients with acne. These results were presented today at the 45th Annual Meeting of the European Society for Dermatological Research (ESDR) in Rotterdam, Netherlands. Dermira’s DRM01 is currently being investigated in a dose-finding Phase 2b clinical trial as a topical treatment in patients with facial acne vulgaris, and topline results from this trial are expected in the first half of 2016 based on current enrollment projections.
“We are excited to share the results of this skin disposition animal study of our DRM01 topical anti-acne product candidate with the dermatology community,” said Hans Hofland, Ph.D., vice president, research at Dermira. “We believe this is the first time that this sophisticated imaging technology has demonstrated the accumulation of a topically administered compound in the sebaceous gland. Based on these and other data, which suggest a unique mechanism of action involving the inhibition of sebum production, DRM01 may represent a compelling, differentiated therapeutic opportunity, subject of course to positive outcomes from our ongoing Phase 2b study for DRM01 and subsequent pivotal trials.”
Results of Skin Disposition Study
In this study, a topical gel formulation containing DRM01 at a concentration of 0% (representing the vehicle only), 4% or 7.5% was applied once or twice daily to the ears of Yorkshire pigs for seven days. The gel formulation used in this study was the same formulation under evaluation in Dermira’s ongoing Phase 2b clinical trial in patients with acne vulgaris. This animal model was selected because of the similarity to human skin and for the well-developed sebaceous glands that are present. Previous studies have shown that DRM01 inhibits the activity of acetyl-coenzyme A carboxylase (ACC), an enzyme that is important for the production of fatty acids, the building blocks of sebum. A direct correlation has been established between the degree of acne improvement and the extent of sebum reduction caused by oral anti-acne medications. This study measured the disposition of DRM01 in the skin following topical administration using matrix-assisted laser desorption/ionization (MALDI) imaging technology.
The MALDI imaging techniques used in this study showed accumulation of DRM01 in the hydrophobic environment of sebaceous glands relative to the surrounding dermis, which suggests that DRM01 effectively localizes in the sebaceous glands. The highest strength DRM01 gel (7.5%) demonstrated the deepest level of penetration into the dermis, the area of the skin where the sebaceous glands are located, suggesting a clear dose response.
About the DRM01 Phase 2b Clinical Trial
The ongoing DRM01 Phase 2b clinical trial is a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle. The goal of the study is to establish the dose for a potential Phase 3 program. 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 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, or IGA, score. Each endpoint will be measured at the end of the 12-week treatment period. Dermira expects topline results from the Phase 2b clinical program in the first half of 2016. 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, in Phase 3 development for the treatment of axillary hyperhidrosis; and DRM01, in Phase 2b development 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, 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 with respect to the interpretation of DRM01 results in animal models, the DRM01 mechanism of action, enrollment of the Phase 2b clinical trial, when results from the Phase 2b clinical program 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 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 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.