February 28, 2015 12:06 PM ET

Pharmaceuticals

Company Overview of Dermira, Inc.

Company Overview

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 has completed Phase II clinical trials for the treatment of moderate-to-severe plaque psoriasis; DRM04, a anticholinergic product that is in 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 programs in preclinic...

275 Middlefield Road

Suite 150

Menlo Park, CA 94025

United States

Founded in 2010

18 Employees

Phone:

650-421-7200

Key Executives for Dermira, Inc.

Dermira, Inc. does not have any Key Executives recorded.

Dermira, Inc. Key Developments

Dermira, Inc. Announces Positive Phase 2b Results for DRM04 in Patients with Hyperhidrosis

Dermira, Inc. announced positive Phase 2b study results for DRM04, its proprietary topical anticholinergic product, in patients with axillary hyperhidrosis, or excessive underarm sweating. Based on the results of this study (DRM04-HH02) and its first Phase 2b study (DRM04-HH01), Dermira plans to initiate a Phase 3 program for DRM04 in axillary hyperhidrosis in the second half of 2015, consistent with previous expectations and subject to an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA). Dermira's Phase 2 hyperhidrosis program included two randomized, double-blind, vehicle-controlled Phase 2b clinical trials in approximately 300 patients with severe, primary axillary hyperhidrosis. The first Phase 2b study (DRM04-HH01), completed in August 2014, demonstrated dose-dependent and, at certain doses, statistically significant reductions in the signs and symptoms of primary axillary hyperhidrosis in patients treated with a topical formulation of an anticholinergic agent that has been approved for systemic administration in other indications, referred to as the topical formulation of the reference agent. The results of the second Phase 2b study (DRM04-HH02) were consistent with the results of the previous Phase 2b study and now provide clinical experience with DRM04, Dermira's proprietary product containing a novel form of the reference agent. Given the substantial clinical experience gained with the topical formulation of the reference agent in Study DRM04-HH01, Study DRM04-HH02 was designed to gain clinical experience with DRM04 prior to the initiation of Phase 3 development. Accordingly, Study DRM04-HH02 was not powered to demonstrate statistical significance. Study DRM04-HH02 was a randomized, double-blind, vehicle-controlled clinical trial assessing the efficacy, safety and pharmacokinetics of DRM04, the topical formulation of the reference agent, and vehicle in 105 patients with severe, primary axillary hyperhidrosis. Patients were randomized equally into five arms to receive DRM04 at one of two concentrations, a topical formulation at one of two concentrations of the reference agent, or vehicle only. Patients enrolled in Study DRM04-HH02 were instructed to apply the study product to each axilla once daily for four weeks using wipes containing either drug product or vehicle only. Primary efficacy endpoints included the absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieved at least a two-grade improvement from baseline in their score on the Hyperhidrosis Disease Severity Scale (HDSS). The HDSS is a widely used patient-reported outcome tool which allows patients to rate the severity of their disease on a four-point scale. Each of these endpoints was assessed at the end of the four-week treatment period. The study also explored a new, proprietary patient-reported outcome instrument, the Axillary Sweating Daily Diary (ASDD), as a potential additional measure of disease severity. The average reduction in sweat production from baseline to week four ranged from 67.7% to 79.8% (72.7 to 105.3 mg per five minutes) in patients in the two arms treated with DRM04, compared to 48.7% (53.9 mg per five minutes) in patients who received the vehicle only. The proportion of patients who achieved at least a two-grade improvement in HDSS score from baseline to week four ranged from 40.9% to 50.0% in patients in the two arms treated with DRM04, compared to 27.3% in patients who received the vehicle only. For patients in the two arms treated with the topical formulation of the reference agent, the results were consistent with those observed in Study DRM04-HH01. Overall, Study DRM04-HH02 met the company's objectives and expectations. ASDD data, which are still being validated, demonstrated greater improvements in disease severity in all treatment arms than in the vehicle arm. Consistent with previous experience in the DRM04-HH01 Phase 2b study, topical treatment was well tolerated with a low incidence of manageable side effects across the arms evaluated in Study DRM04-HH02. Study DRM04-HH01 was a randomized, double-blind, vehicle-controlled trial that enrolled 198 patients with severe, primary axillary hyperhidrosis. Patients were randomized equally into five arms to receive the topical formulation of the reference agent at one of four concentrations, including each of the concentrations evaluated in Study DRM04-HH02, or vehicle only for four weeks. The two primary efficacy endpoints evaluated in Study DRM04-HH01 were the same as those evaluated in Study DRM04-HH02. Study DRM04-HH01 demonstrated dose-dependent and, at certain doses, statistically significant improvements relative to vehicle in both of the primary efficacy endpoints.

Dermira, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 02:15 PM

Dermira, Inc. Presents at Leerink's Global Healthcare Conference, Feb-12-2015 02:15 PM. Venue: Waldorf Astoria New York, New York, New York, United States. Speakers: Thomas G. Wiggans, Co-Founder, Chairman and Chief Executive Officer.

Dermira, Inc. and UCB S.A. Announce Start of Phase 3 Program for CIMZIA(R) (certolizumab pegol) in Psoriasis

Dermira, Inc. and UCB announced that the first patients have been dosed in the Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. This is an important step forward in the collaboration between Dermira and UCB in the development of solutions for patients with moderate-to-severe plaque psoriasis, a severe autoimmune disease.1 CIMZIA® is not currently approved for the treatment of psoriasis by any regulatory authority worldwide. Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-center studies 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, 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 study is to compare the efficacy and safety of certolizumab pegol to etanercept. The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on certolizumab pegol achieving 75% or greater disease improvement from baseline, compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI 75) at week 12. CIMPASI-1 and CIMPASI-2, the placebo-controlled studies, have co-primary endpoints comprising both PASI 75 and the percentage of patients achieving at least a two-point improvement to a final score representing clear or almost clear skin on a five-point Physician's Global Assessment scale, each compared with placebo, at week 16. Patients in each trial may receive blinded treatment for up to 48 weeks and, based on current enrollment projections, top-line data from these studies are expected in 2017. Patients in each study may receive open-label treatment with certolizumab pegol for up to an additional 96 weeks. In a completed, 176-patient Phase 2 study, PASI 75 was achieved by 75% (44/59), 83% (48/58) and 7% (4/59) of patients in the certolizumab pegol 200 mg, 400 mg and placebo groups, respectively (p<0.001 for both treatment arms vs. placebo). These Phase 2 results support the continued Phase 3 clinical program for the development of certolizumab pegol in psoriasis.

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