10/05/2017 | Press release | Distributed by Public on 10/05/2017 06:04
- Phase 3 pivotal trials enrolled a total of 1,503 patients
- Topline efficacy and safety results expected in first quarter of 2018
MENLO PARK, Calif., Oct. 05, 2017 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today announced the completion of patient enrollment in its CLAREOS-1 and CLAREOS-2 Phase 3 clinical trials. Both trials are designed to evaluate the efficacy and safety of olumacostat glasaretil (formerly DRM01) in patients ages nine years and older with facial acne vulgaris. Olumacostat glasaretil is a novel, small molecule designed to target sebum production following topical application.
'Despite the number of options currently available to treat acne, the majority of these treatments have been available for more than 30 years, and patients of all ages continue to seek new options to effectively and safely manage this common skin condition,' said Luis Peña, chief development officer at Dermira. 'We continue to believe that olumacostat glasaretil represents a potential new treatment option for acne with an exciting new mechanism of action that is designed to target sebum, and we look forward to sharing topline results from the Phase 3 clinical program in the first quarter of next year.'
Dermira expects to announce topline efficacy and safety results from the CLAREOS-1 and CLAREOS-2 studies in the first quarter of 2018. CLARITUDE, a third trial assessing the long-term safety of olumacostat glasaretil, will continue for an additional nine months. Positive results from CLAREOS-1 and CLAREOS-2, the completion of CLARITUDE and other registration-enabling studies and activities are required to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for olumacostat glasaretil.
About 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 efficacy and safety of olumacostat glasaretil compared to vehicle to support a potential NDA submission to the FDA. The program enrolled total of 1,503 patients (CLAREOS-1, n=759 and CLAREOS-2, n=744) ages nine years and older with moderate-to-severe acne vulgaris at 94 sites in the United States, Canada and Australia. In each trial, patients were randomized in a 2:1 fashion to receive either olumacostat glasaretil at a concentration of 5% or vehicle twice daily for 12 weeks.
Consistent with the design of two earlier Phase 2 trials, inclusion criteria required a minimum of 20 inflammatory and 20 non-inflammatory facial 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 and the proportion of patients achieving at least a two-grade improvement from baseline to a grade of 0 or 1 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 from baseline on the five-point IGA scale. 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 includes 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.
About Olumacostat Glasaretil
Olumacostat glasaretil is a novel, small molecule designed to target 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.
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.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira's pipeline includes four late-stage product candidates that could have a profound impact on the lives of patients: CIMZIA (certolizumab pegol), for which marketing applications have been submitted for potential approval for the treatment of moderate-to-severe chronic plaque psoriasis, in collaboration with UCB Pharma S.A.; glycopyrronium tosylate (formerly DRM04), for which a Phase 3 program has been completed for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); olumacostat glasaretil (formerly DRM01), in Phase 3 development for the treatment of acne vulgaris; and lebrikizumab, for which Dermira plans to initiate a Phase 2b dose-ranging study for the treatment of moderate-to-severe atopic dermatitis. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://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 Dermira's goal of building a leading medical dermatology company dedicated to delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; olumacostat glasaretil representing a potential new treatment option for acne; the design of the olumacostat glasaretil Phase 3 clinical program; the successful completion of, and timing expectations for the receipt of data from, the olumacostat glasaretil Phase 3 program; a potential NDA submission to the FDA for olumacostat glasaretil; and Dermira's plan to initiate a Phase 2b dose-ranging study of lebrikizumab for moderate-to-severe atopic dermatitis. 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.
Vice President, Corporate Communications
Investors:Ian Clements, Ph.D.
Vice President, Investor Relations
Robert H. Uhl