Company Overview of Dermira, Inc.
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
Key Executives for Dermira, Inc.
Co-Founder, Chairman and Chief Executive Officer
Total Annual Compensation: $371.3K
Co-Founder and Executive Vice President of Product Development
Total Annual Compensation: $300.0K
Chief Financial Officer and Chief Operating Officer
Total Annual Compensation: $224.7K
Compensation as of Fiscal Year 2014.
Dermira, Inc. Key Developments
Dermira Presents Data from DRM01 Phase 2A Trial at European Academy of Dermatology and Venereology
Oct 7 15
Dermira, Inc. announced the presentation of data for DRM01, a novel, topical sebum inhibitor in development for the treatment of acne. Topline data from the company's Phase 2a study showed that DRM01 met all of the primary efficacy endpoints, demonstrating statistically significant improvements relative to vehicle in the reduction of lesion counts and the proportion of patients who achieved a successful improvement in Investigator's Global Assessment (IGA) score at week 12. In addition, newly presented data suggest that a treatment difference in these endpoints was observed as early as the first efficacy assessment, which was conducted after four weeks of the 12-week treatment period. As previously reported, topical treatment with DRM01 was generally well tolerated. These results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2015 being held October 7-11, 2015 in Copenhagen. DRM01 Phase 2a Trial Design and Results: This Phase 2a clinical trial was a randomized, multi-center, double-blind, vehicle-controlled study that enrolled 108 patients with moderate or severe acne. Inclusion criteria required a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an IGA score of three or greater on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease. Patients were instructed to apply either DRM01 at a concentration of 7.5% or vehicle to the face twice daily for 12 weeks. A total of 53 subjects were randomized to receive DRM01, and the other 55 were randomized to receive vehicle only. The primary efficacy endpoints used in this trial consisted of absolute changes from baseline to week 12 in the numbers of inflammatory and non-inflammatory lesions and the proportion of patients with at least a two-grade improvement from baseline to week 12 in IGA score. DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints. The number of inflammatory lesions in patients treated with DRM01 was reduced by an average of 19.3 compared to 13.3 in patients who received the vehicle only (p=0.0003), or an average percentage reduction of 63.9% and 45.9%, respectively (p=0.0006). The number of non-inflammatory lesions in patients treated with DRM01 was reduced by an average of 19.9 compared to 11.2 in patients who received the vehicle only (p=0.0032), or an average percentage reduction of 48.1% and 28.8%, respectively (p=0.0025). At the end of the 12-week treatment period, 24.5% of patients (13/53) who received DRM01 achieved a successful improvement in the IGA score (minimum two-grade improvement), in comparison with 7.3% of patients (4/55) who received the vehicle only (p=0.0070). At week 4, the first efficacy assessment time point, subjects in the DRM01 group achieved numerically greater reductions from baseline in inflammatory and non-inflammatory lesion counts than subjects in the vehicle group (p=0.0666 and p=0.0328, respectively). In addition, the proportion of subjects who achieved a = 2-grade improvement in IGA score was numerically greater in the DRM01 group than in the vehicle group (p=0.1591). DRM01 was well-tolerated with adverse events mild or moderate in severity. The most frequently reported adverse event was nasopharyngitis, which was reported in 13 (24.5%) of the patients treated with DRM01 and in 7 (12.7%) of the patients who received vehicle and which was considered unrelated to treatment. Application-site conditions, which are frequently observed in most clinical trials of topical products, also were observed. No treatment-related serious adverse events were reported.
Dermira, Inc. Announces Board Changes
Sep 30 15
Dermira, Inc. announced the election of Kathleen Sebeliusto its board of directors. Ms. Sebelius was Secretary of Health and Human Services from 2009 to 2014. As Secretary, she presided over 11 operating divisions, including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and National Institutes of Health (NIH), and an annual budget approaching $1 trillion. She also oversaw the passage and implementation of the Affordable Care Act, the most significant health reform in half a century. In addition, Dermira announced that Wende Hutton, general partner at Canaan Partners, will be leaving Dermira's board and complete her service as a director on December 31, 2015.
Dermira, Inc. Announces New Data for DRM01, a Novel, Topical Sebum Inhibitor in Development for the Treatment of Acne
Sep 10 15
Dermira, Inc. announced the presentation of new data for DRM01, a novel, topical sebum inhibitor in development for the treatment of acne. The results from a study in Yorkshire pigs demonstrated that DRM01 penetrates the skin in a dose- and formulation-dependent manner and accumulates in the sebaceous glands. These animals have skin morphology and physiology similar to human skin, including well-developed sebaceous glands, suggesting that the compound may effectively localize at the site of increased sebum production in the skin of patients with acne. Results of skin disposition study: In this study, a topical gel formulation containing DRM01 at a concentration of 0% (representing the vehicle only), 4% or 7.5% was applied once or twice daily to the ears of Yorkshire pigs for seven days. The gel formulation used in this study was the same formulation under evaluation in Dermira's ongoing Phase 2b clinical trial in patients with acne vulgaris. This animal model was selected because of the similarity to human skin and for the well-developed sebaceous glands that are present. Previous studies have shown that DRM01 inhibits the activity of acetyl-coenzyme A carboxylase (ACC), an enzyme that is important for the production of fatty acids, the building blocks of sebum. A direct correlation has been established between the degree of acne improvement and the extent of sebum reduction caused by oral anti-acne medications. This study measured the disposition of DRM01 in the skin following topical administration using matrix-assisted laser desorption/ionization (MALDI) imaging technology. The MALDI imaging techniques used in this study showed accumulation of DRM01 in the hydrophobic environment of sebaceous glands relative to the surrounding dermis, which suggests that DRM01 effectively localizes in the sebaceous glands. The high strength DRM01 gel (7.5%) demonstrated the deepest level of penetration into the dermis, the area of the skin where the sebaceous glands are located, suggesting a clear dose response. The ongoing DRM01 Phase 2b clinical 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. The goal of the study is to establish the dose for a potential Phase 3 program. In the Phase 2b trial, approximately 400 adult patients with moderate-to-severe facial acne vulgaris will be randomized into five separate arms
evaluating different DRM01 dosing regimens compared to vehicle. Approximately 300 patients will receive DRM01, and approximately 100 will receive vehicle. Consistent with the preceding Phase 2a trial and in accordance with the published U.S. Food and Drug Administration 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, or IGA, score. Each endpoint will be measured at the end of the 12-week treatment period. Dermira expects topline results from the Phase 2b clinical program in the first half of 2016. 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.
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