Menlo Park, CA — 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 the completion of patient enrollment for the CIMPACT clinical trial of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. The CIMPACT study is the third and final clinical trial of the CIMZIA Phase 3 development program in moderate-to-severe chronic plaque psoriasis to complete enrollment, following the completion of enrollment for the CIMPASI-2 Phase 3 trial in September 2015 and CIMPASI-1 Phase 3 trial in November 2015. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
Based on completion of enrollment in all three Phase 3 trials of the psoriasis program, Dermira now expects to announce topline data for the trials by the end of the first quarter of 2017, following completion of the 48-week blinded treatment period in each of the trials. Previously, the company had expected to announce topline data in 2017.
“I am very pleased with the completion of patient enrollment for CIMPACT, our third and final CIMZIA Phase 3 clinical trial in psoriasis, which, similar to our CIMPASI-1 and CIMPASI-2 CIMZIA Phase 3 trials, was achieved ahead of schedule,” stated Tom Wiggans, chairman and chief executive officer of Dermira. “We are excited about the continued collaboration with UCB and progress towards our goal of bringing this important potential therapy to the millions of patients with moderate-to-severe plaque psoriasis, an often debilitating skin disease.”
As previously disclosed, Dermira expects that marketing applications for CIMZIA in adults with moderate-to-severe chronic plaque psoriasis in the U.S. and EU will be based on the results of the primary endpoints at 12 or 16 weeks, as applicable, with additional data collected through week 48 to provide further support for dosing recommendations. While any marketing approval will be based on the overall results of the trials, the company expects that marketing approval for CIMZIA in moderate-to-severe chronic plaque psoriasis in the U.S. and EU will require that each of the CIMPASI trials (CIMPASI-1 and CIMPASI-2) demonstrates that CIMZIA produces a statistically significant improvement relative to placebo in each of its co-primary endpoints, which are the proportion of patients who achieve (1) a 75% improvement in disease severity, as measured by the Psoriasis Area and Severity Index (PASI 75), and (2) an improvement of at least two points to a final score representing clear or almost clear skin on a five-point Physician’s Global Assessment scale (PGA), each as measured at week 16. In addition, the company expects that EU approval for CIMZIA in moderate-to-severe plaque psoriasis will require that the CIMPACT trial demonstrates that CIMZIA produces a statistically significant improvement relative to placebo and to etanercept (marketed as Enbrel®*) in PASI 75, as measured at week 12.
About the CIMZIA Phase 3 Clinical Program
The Phase 3 clinical development program, which is led by Dermira in collaboration with UCB, is designed to evaluate the efficacy and safety of certolizumab pegol in the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. It consists of three studies that have enrolled a total of approximately 1,000 patients, including patients with and without prior treatment experience with biologic products.
The two CIMPASI studies (CIMPASI-1 and CIMPASI-2), each of which has completed enrollment of approximately 225 patients, are randomized, blinded, parallel group, placebo-controlled, multi-center trials designed to evaluate the efficacy and safety of certolizumab pegol in the treatment of patients with moderate-to-severe chronic plaque psoriasis. The third study, CIMPACT, which has now completed enrollment of approximately 540 patients, is a randomized, blinded, parallel group, placebo-controlled and blinded, active-controlled, multi-center study with a primary objective of comparing the efficacy and safety of certolizumab pegol to placebo in the treatment of patients with moderate-to-severe chronic plaque psoriasis. A secondary objective of the CIMPACT trial is to compare the efficacy of certolizumab pegol to etanercept.
The primary endpoint in CIMPACT, the placebo- and active-controlled study, is PASI 75, compared with placebo, as measured at week 12. CIMPASI-1 and CIMPASI-2, the placebo-controlled studies, have co-primary endpoints comprising both PASI 75 and PGA, each compared with placebo, at week 16. Patients in each trial may receive blinded treatment for up to 48 weeks. Patients in each study may receive open-label treatment with certolizumab pegol for up to an additional 96 weeks.
Under the terms of the agreement announced in July 2014, Dermira obtained exclusive rights to develop certolizumab pegol in psoriasis in the United States, Canada and the European Union. Subject to regulatory approval of CIMZIA in psoriasis, Dermira is granted an exclusive commercial license to market CIMZIA to dermatologists in the U.S. and Canada.
*ENBREL® (etanercept) is a registered trademark of Amgen Inc.
CIMZIA® is a registered trademark of the UCB Group of Companies.
Psoriasis is a common, chronic, relapsing, immune-mediated, inflammatory disorder with primary involvement of the skin. It affects two to three percent of the world’s population – approximately 125 million people worldwide. Psoriasis signs and symptoms can vary from person to person but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.
CIMZIA is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
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 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 statements with respect to timing expectations for the receipt and announcement of topline efficacy and safety data from the Phase 3 studies; the desired outcomes of the Phase 3 studies and goal of using certolizumab pegol as an effective treatment for patients with moderate-to-severe plaque psoriasis; and guidelines for interpreting the topline efficacy and safety data from the Phase 3 studies, including expectations regarding necessary achievements to enable registrations in the U.S. and EU. 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 design, implementation and outcomes of our clinical trials; our dependence on third-party clinical research organizations, manufacturers and suppliers; 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.