- First patients dosed in Phase 3 program evaluating olumacostat glasaretil, a novel topical molecule, in patients with acne vulgaris
- Two Phase 3 trials expected to enroll a total of 1,400 patients
- Topline results expected in the first half of 2018
MENLO PARK, Calif., Jan. 03, 2017 (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 dosing of the first patients in the Phase 3 program evaluating the safety and efficacy of olumacostat glasaretil (formerly DRM01), a novel, small molecule designed to reduce sebum production following topical application, in patients with acne vulgaris.
“Acne is a highly prevalent skin condition that negatively affects millions of people of all ages,” said Luis Peña, chief development officer of Dermira. “Despite the treatment options currently available, many people are still seeking new therapies that are safe, effective and well tolerated. The start of the olumacostat glasaretil Phase 3 clinical program is an important milestone for Dermira and puts us one step closer to potentially offering patients a new, topical treatment option that targets an underlying cause of acne that is not addressed by available topical therapies.”
Olumacostat Glasaretil Phase 3 Program
The Phase 3 clinical program consists of two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, designed to assess the safety and efficacy of olumacostat glasaretil compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The program is expected to enroll a total of approximately 1,400 patients ages nine and older with moderate-to-severe acne vulgaris at approximately 100 sites in the United States, Canada and Australia. In each trial, approximately 700 patients will be randomized and instructed to apply either olumacostat glasaretil at a concentration of 5.0% or vehicle, in a 2:1 fashion, twice daily to the face for 12 weeks.
At the recommendation of the FDA, one of the Phase 3 trials will also allow patients to apply olumacostat glasaretil or vehicle to acne-affected areas on the chest, back or shoulders. This is intended to provide additional safety data on the potential real-world use of olumacostat glasaretil. No efficacy endpoints will be measured on these areas.
Consistent with the two earlier Phase 2 trials, inclusion criteria require a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an Investigator’s Global Assessment (IGA) score of three or four on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease. The primary endpoints of both trials will evaluate the absolute changes from baseline in inflammatory and non-inflammatory lesion counts on the face and the proportion of patients achieving at least a two-grade improvement and a grade of 0 or 1 from baseline on the five-point IGA scale. Secondary endpoints will evaluate the percentage change from baseline in inflammatory and non-inflammatory lesion counts on the face and the proportion of patients achieving at least a two-grade improvement on the five-point IGA scale from baseline. All efficacy endpoints will be measured at the end of the 12-week treatment period. Safety will also be assessed.
The Phase 3 program also will include an open-label study, CLARITUDE, assessing the long-term safety of olumacostat glasaretil, in which patients from either of the two Phase 3 studies will be permitted to continue to receive treatment for up to an additional 36 weeks.
Topline results from CLAREOS-1 and CLAREOS-2 are expected in the first half of 2018.
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting approximately 50 million Americans and 85% of all teenagers. Acne is caused by the accumulation of dead skin cells, oil and bacteria in pores. It is characterized by clogging of the pores and associated local skin lesions. Acne lesions are believed to result from an interaction of multiple pathogenic, or contributing, factors, including excessive sebum production. Acne is not just about blemishes on the skin; it can also affect a person’s quality of life, resulting in social, psychological and emotional impairments.
About Olumacostat Glasaretil
Olumacostat glasaretil is a novel, small molecule designed to reduce sebum production following topical application. 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. Olumacostat glasaretil 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 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 Phase 3 product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
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 potential offering of olumacostat glasaretil as a novel, topical acne treatment option to patients; the design, description of and enrollment expectations for the olumacostat glasaretil Phase 3 program; and the successful completion of, and timing expectations for the receipt of data from, the olumacostat glasaretil Phase 3 program. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause 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 Dermira’s clinical trials; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; and Dermira’s 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 Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes 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