Biotech Values

[DewDiligence]

RVNC starts phase-2 trial of topical botulinum toxin for excessive armpit sweating:

http://finance.yahoo.com/news/revance-therapeutics-initiates-phase-2-200200103.html

Revance's Phase 2, randomized, double-blind, dose-ranging, placebo-controlled trial will evaluate the safety and efficacy of RT001 topical gel for the treatment of primary axillary hyperhidrosis. A total of approximately 60 adult patients with a diagnosis of primary axillary hyperhidrosis will be enrolled at multiple sites in the U.S. The patients will be randomized into one of three parallel treatment groups (two doses of RT001 topical gel and one placebo topical gel). The product will be applied to both underarms.

An interim efficacy and safety analysis at Day 28 after treatment is planned. The primary efficacy endpoints are the proportion of subjects who are 2-point or greater responders from baseline using the Hyperhidrosis Disease Severity Scale (HDSS) and the absolute change from baseline in the gravimetrically measured sweat production. Secondary efficacy endpoints include the change from baseline in total Dermatology Life Quality Index (DLQI) scores.

…The company plans to release interim data from this study by year end 2015

As previously noted on this board, I’m not a fan of RVNC’s topical agent, and I would be more bullish on the company’s prospects if they were to drop the topical program and focus exclusively on the injected botulinum toxin that purportedly lasts longer than Botox and other marketed toxins. However, I’ll grant that the hyperhidrosis indication is probably the best indication for testing the topical agent (if it has to be tested at all).

RVNC’s lead indication for the topical agent is crows feet, where a phase-3 trial is expected to start during 2015 (#msg-114249260).

p.s. The internal codename for the topical agent is now RTT150 (f/k/a RT001).