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AN FRANCISCO — In a meeting with Dermira (DERM) Tuesday, CEO Tom Wiggans and his management team said they’re on track to report results this quarter from twin Phase 3 clinical trials of its novel, acne-clearing drug DRM01. It’s a pivotal moment for the small biotech company, targeting a very common skin disease with the only topical drug designed to shut down the production of sebum, the oily, waxy matter excreted by tiny glands in the skin.

There are no certainties in biotech, but I’ll stick my neck out and predict Dermira wins with DRM01. In its Phase 2 study, the drug showed a significant and consistent ability to reduce by half the number of inflammatory and non-inflammatory lesions compared to a vehicle control. Study investigators also assessed DRM01 patients and found a significant doubling of the improvement in their overall acne severity score compared to control. The drug’s safety profile was clean.

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  • I would note that the Phase IIb results (last reported for this drug) reflected the endpoint of “at least a two-point improvement from baseline on the five-point Investigator’s Global Assessment (IGA) scale”. This is not as rigorous as other drugs in the space, which add a stipulation of achieving IGA score of 0-1. Consider Sol-Gel Technologies, which more recently reported data under this more stringent endpoint.

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