- 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
“Acne is a highly prevalent skin condition that negatively affects millions of people of all ages,” said Luis Peña, chief development officer of
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
At the recommendation of the
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
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.
In addition to filings with the
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
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