News Column

Dermira Reports Development and Corporate Progress

February 17, 2014

Dermira, a development-stage biotechnology company focused on developing medical dermatology products for dermatologists and their patients, announced the progress of three programs into five Phase 2, proof of concept, clinical trials.

In a release, the Company noted:

The programs include DRM01, a novel, sebum inhibitor for acne; DRM02, a unique PDE4 inhibitor for inflammatory skin diseases; and DRM04 for hyperhidrosis.

"Dermatology has long suffered from a tepid pace of innovation, a fact accentuated by recent pharmaceutical company consolidations in the field. This provides a significant opportunity for the development of novel compounds in areas of high patient need. Our advancement of three compounds into five clinical trials provides substantial potential to address the needs of many patients by creating new therapies to fulfill these dermatology requirements," said Tom Wiggans, CEO of Dermira.

DRM01, a topical, new chemical entity, is a prodrug designed to optimize delivery of a well-characterized lipid synthesis inhibitor to the sebaceous gland. In pre-clinical studies, DRM01 has demonstrated potent inhibition of key components of sebum production, thereby providing the potential to break the pathogenesis cycle that drives the development of acne lesions. DRM01 has completed patient enrollment in a Phase 2a program at multiple Canadian sites conducted under a Clinical Trial Application (CTA) with data expected in Q3 14.

DRM02, a novel, topical, small-molecule PDE4 inhibitor, has demonstrated activity in a variety of skin inflammation models. PDE4 inhibition down-regulates key effector molecules, including IL17, IL23, and TARC that play an important role in a range of common inflammatory skin diseases. Dermira has completed enrollment in three Phase 2a clinical trials with DRM02 in psoriasis, atopic dermatitis and rosacea. These trials are also being conducted in Canada under CTAs with data expected for all three trials in Q2 14.

In addition, Dermira is enrolling a Phase 2b clinical trial evaluating DRM04, a topical treatment for primary axillary hyperhidrosis, an area of significant patient need. The DRM04 Phase 2b program is designed to identify the optimal dose for Phase 3 studies based on data from a Phase 2a proof-of-concept study that demonstrated robust efficacy in this underserved patient population. Phase 2b data are expected in Q3 14.

Concurrent with the five Phase 2 programs, Dermira is optimizing the formulation of DRM05 (formerly lemuteporfin topical solution, or LTS) to enhance its activity. DRM05 would be a unique photodynamic therapy for acne.

"Dermatologists need products to treat patients with complicated skin conditions. Too many patients are dissatisfied with their treatments, and in many cases, the only options dermatologists have are decades old. Dermatologists are excited by new technologies and will support innovative products. Dermira's pipeline provides the opportunity to forge the future of dermatology," said Dr. Eugene Bauer, Chief Medical Officer at Dermira.

Dermira is also pleased to announce that Luis Pena has been promoted to Executive Vice President of Product Development. Luis joined Dermira as a founder in 2010 from Stiefel, a GSK Company, where he was Vice President and Head of Global Prescription Product Development. His extensive experience in the biotechnology industry also includes leadership roles in product development at Connetics, Theravance and Genentech. His expertise in product development and portfolio management both inside and outside of the dermatology field has made him an integral part of the Dermira team.

"It is exciting to be at Dermira building an organization to address innovation in dermatology. I am especially proud to help lead the expert, high-performing team we have assembled that enabled Dermira to progress our pipeline to conduct five Phase 2 trials," said Luis Pena, Executive Vice President of Product Development at Dermira.

Tom Wiggans, the Chief Executive Officer, will present a Dermira overview at the 2014 Leerink Global Healthcare Conference.

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Source: Health & Beauty Close - Up


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