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
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
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.
Dermira is also pleased to announce that
"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
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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: