- Treatment period for DRM04 ARIDO trial completed
- Phase 3 acne clinical program for olumacostat glasaretil initiated
- Topline data for third and final CIMZIA® (certolizumab pegol) Phase 3 trial expected first quarter of 2017
- Chief Commercial Officer appointed
Clinical Pipeline Update and Key Milestones
- Completed treatment period for DRM04 ARIDO trial – In
December 2016, the treatment period for ARIDO, an open-label Phase 3 trial assessing the long-term safety of DRM04, was completed. Based on a preliminary review, the safety and tolerability profile for DRM04 appears consistent with what was observed in the ATMOS-1 and ATMOS-2 Phase 3 clinical trials.
- Initiated olumacostat glasaretil Phase 3 clinical program – In
January 2017, Dermiraannounced 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. The Phase 3 clinical program consists of two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, which are 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, Canadaand Australia. 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.
- Topline results from final Phase 3 CIMZIA trial expected in first quarter of 2017 – Topline results from CIMPACT, the third and final trial of the CIMZIA® (certolizumab pegol) Phase 3 psoriasis program, are expected in the first quarter of 2017. Subject to positive results from the CIMPACT trial,
Dermiraand UCB S.A.plan to submit data from the Phase 3 program to regulatory authorities to support potential approvals for CIMIZIA as a treatment option for patients with moderate-to-severe chronic plaque psoriasis. Dermiraand UCB previously announced topline results from CIMPASI-1 and CIMPASI-2, two identical, Phase 3, multi-center, placebo-controlled clinical trials evaluating the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. In both the CIMPASI-1 and CIMPASI-2 trials, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo for both treatment doses. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
- Submission of New Drug Application (NDA) to
U.S. Food and Drug Administration( FDA) for DRM04 expected in second half of 2017 – Subject to a pre-NDA meeting with the FDAand other registration-enabling activities, Dermiraplans to submit a marketing application to the FDAfor approval of DRM04 for the treatment of axillary hyperhidrosis in the second half of 2017.
Recent Leadership Updates
Lori Lyons-Williamsas Chief Commercial Officer – In January 2017, Dermiraannounced the appointment of Ms. Lyons-Williams, who will be responsible for developing and implementing the commercial strategy for Dermira’s Phase 3 product candidates: CIMZIA, in collaboration with UCB, DRM04 and olumacostat glasaretil. Ms. Lyons-Williams joined after a 15-year tenure in various leadership positions at Allergan, Inc.
- Expanded Board of Directors – In
January 2017, Dermiraannounced the election of Emmanuel Caeymaex, Executive Vice President, Immunology Patient Value Unit Head at UCB S.A., to its board of directors. Mr. Caeymaex leads the worldwide development and commercialization of innovative patient-oriented solutions for people suffering from various auto-immune disorders and skin conditions. Mark McDade, who formerly served as an Executive Vice President and the Chief Operating Officer of UCB, had been UCB’s designee to Dermira’s board of directors since 2014. Mr. McDade will continue to serve as a director on Dermira’s board.
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 timing expectations for the receipt and announcement of topline efficacy and safety data from the CIMPACT study; expectations regarding results from the CIMZIA Phase 3 clinical trial program; the potential submission of marketing applications for CIMIZIA and DRM04 and the timing expectations for such applications; potential approval of CIMZIA as a treatment option for moderate-to-severe plaque psoriasis; potential approval of DRM04 for the treatment of axillary hyperhidrosis; the design, description of and enrollment expectations for the olumacostat glasaretil Phase 3 program; the successful completion of, and timing expectations for the receipt of data from, the olumacostat glasaretil Phase 3 program; the anticipated safety and tolerability profile for DRM04 based on preliminary review of results from the ARIDO trial; and the potential commercialization of Dermira’s product candidates. 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, including related to further analysis of the results of our studies; the outcome of future discussions with regulatory authorities relating to Dermira’s clinical programs; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; 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.
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