Biotech Values

[DewDiligence]

(AGN/RVNC)—More color on DERM's hyperhidrosis data:

http://www.fiercebiotech.com/biotech/dermira-posts-broadly-positive-results-for-excessive-sweat-drug

The Californian biotech Dermira (DERM) says its experimental sweat drug DRM04 passed one Phase III test but narrowly missed its target on a second late-stage trial--although analysts believe this will still be good enough to reap an FDA approval.

The company has released topline results from its Phase III Atmos-1 and Atmos-2 pivotal trials for DRM04--a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis (aka excessive underarm sweating).

The data showed that in the Atmos-2 trial, the once-daily topical treatment DRM04 produced statistically significant improvements for both co-primary endpoints and both secondary endpoints compared to vehicle. The co-primaries were measured over 4 weeks and assessed the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD)--Dermira’s own patient report card--and the average absolute change from baseline in gravimetrically-measured sweat production.

…But in the Atmos-1 trial, the drug narrowly missing statistical significance on the average gravimetric measure of sweat production. After playing with the numbers, however, Dermira spun this into a more positive outcome, as it excluded an analysis center (something it was permitted to do) with “extreme outlier data”, which made the drug’s outcomes look a little better in Atmos-1.

One of the more recent drugs to be approved for this condition it Allergan’s (AGN) injectable Botox, which has a license in severe primary axillary hyperhidrosis—but only after topical treatments have failed. [RVNC is pursing hyperhidrosis with its topical botulinum toxin, RT001.]

…Dermira said it plans to submit an NDA to the FDA for the approval of DRM04 for the second half of 2017—subject to it completing the Phase III ARIDO trial, an open-label trial assessing the long-term safety of DRM04.