Dermira, Inc., a specialty biopharmaceutical company, focuses on the development and commercialization of medical dermatology products to dermatologists and their patients primarily in the United States. The company’s late-stage product candidates comprise Cimzia, an injectable biologic tumor necrosis factor-alpha inhibitor, which is in Phase III clinical trial for the treatment of moderate-to-severe plaque psoriasis; DRM04, a small-molecule anticholinergic product that has completed a Phase IIb clinical trial for the treatment of hyperhidrosis or excessive sweating; and DRM01, a sebum inhibitor, which has completed a Phase IIa clinical trial for the treatment of acne. Its early-stage progra...
275 Middlefield Road
Menlo Park, CA 94025
Founded in 2010
Dermira, Inc. Completes Patient Enrollment for Third CIMZIA (certolizumab pegol) Phase 3 Clinical Trial in Psoriasis Program
Jan 8 16
Dermira, Inc. 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.
Dermira, Inc. Provides DRM01 and DRM04 Development Program Updates
Jan 7 16
Dermira, Inc. announced an update for its DRM01 and DRM04 development programs. Patient enrollment has been completed for the DRM01 Phase 2b trial in patients with facial acne vulgaris, and the company expects to announce topline efficacy and safety results in the second quarter of 2016. In addition, based on current enrollment projections, topline results for company’s two identical Phase 3 clinical trials for DRM04, a potential treatment for axillary hyperhidrosis (excessive underarm sweating), are expected mid-2016, compared to previous guidance of the second half of 2016. The DRM01 Phase 2b trial is a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in patients with facial acne vulgaris. The goal of the study is to establish the optimal dose for a potential Phase 3 program. In the Phase 2b trial, approximately 400 adult patients with moderate-to-severe facial acne vulgaris were randomized into five separate arms evaluating different DRM01 dosing regimens compared to vehicle. Approximately 300 patients will receive DRM01, with 100 patients in each of three DRM01 treatment arms, and approximately 100 patients will receive vehicle. Consistent with the preceding Phase 2a trial and in accordance with the published U.S. Food and Drug Administration (FDA) draft guidance for the development of acne drugs, the primary endpoints are the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point Investigator’s Global Assessment (IGA) score. Each endpoint will be measured at the end of the 12-week treatment period. The trial is being conducted at approximately 30 sites in the U.S. and Canada. Pending the successful completion of the Phase 2b trial and all applicable non-clinical work, Dermira expects to include both adult and adolescent patients in its Phase 3 program. The DRM04 Phase 3 program is designed to assess the safety and efficacy of DRM04 to support a potential New Drug Application (NDA) submission to the FDA. The program consists of two pivotal studies, ATMOS-1 and ATMOS-2, to assess the safety and efficacy of DRM04 compared to vehicle and an open-label study, ARIDO, to assess the long-term safety of DRM04. The program is being conducted at approximately 60 trial sites in the U.S. and Germany. The ATMOS-1 and ATMOS-2 studies are identical, randomized, double-blind, vehicle-controlled trials enrolling a total of approximately 660 adult and adolescent (ages nine and older) patients with primary axillary hyperhidrosis. In each of these trials, 220 patients will receive DRM04 and 110 patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only. The co-primary endpoints are the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company’s proprietary patient-reported outcome (PRO) instrument. Secondary efficacy endpoints include (1) the proportion of subjects who have at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and (2) the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production. Both the primary and secondary endpoints will be assessed at the end of the four-week treatment period. Topline results from the ATMOS-1 and ATMOS-2 trials are now expected mid-2016. In the open-label ARIDO study assessing the long-term safety of DRM04, patients from either of the ATMOS Phase 3 studies are permitted to continue to receive active treatment for up to an additional 44 weeks from the end of the 4-week treatment periods in the ATMOS studies. Pending the successful completion of these studies and other registration-enabling activities, Dermira expects to submit an NDA to the FDA in the second half of 2017.
Dermira, Inc.(NasdaqGS:DERM) added to NASDAQ Biotechnology Index
Dec 21 15
Dermira, Inc. has been added to NASDAQ Biotech Index.