Biotech Values

[DewDiligence]

RVNC reports unimpressive phase-2 data for RT001 in hyperhidrosis (excessive underarm sweating):

http://finance.yahoo.com/news/revance-announces-positive-phase-2-210500629.html

The trial was designed to evaluate safety and efficacy of two doses of RT001 applied on a single day of treatment. Although the trial sample size was not chosen to meet statistical significance, using quantitative gravimetric measurements, the data was positive and showed that a single treatment of RT001 topical gel achieved clinically meaningful efficacy at Week 4. Using the qualitative Hyperhidrosis Disease Severity Scale (HDSS), RT001 showed a strong efficacy trend for both 1-point and 2-point improvement.

…On the primary qualitative efficacy assessment of a 2-point or greater responders from baseline using the HDSS, at Weeks 1 and 2 the results ranged from a 23.8% to 13.3 % improvement for RT001 compared to a range of 17.6% to 11.8% improvement for placebo. By Week 4, there was a 14.3% to 13.3% improvement for RT001, compared to a 29.4% improvement in patients who received placebo [i.e. the placebo arm did better].

The PR calls these data positive, but that’s simply spin.

I’ve previously posted (#msg-114249260, bottom) that RVNC ought to abandon RT001—the topical botulinum toxin—and just focus on RT002—the injected botulinum toxin that was recently tested against Botox in glabellar lines (#msg-118159012).

Even if RT001 were to have efficacy, I question whether the product would be approved; bad stuff can happen while a patient is sitting for 30 minutes with exposed botulinum toxin while waiting for the RT001 gel to sink in.

Nevertheless, according to the above PR RVNC plans to advance RT001 to a larger phase-2 trial in hyperhidrosis. I think they’re making a mistake.

p.s. No CC for today's data as there was for the BELMONT study of RT002. It would be tough to defend some of the stuff stated in today's PR on a CC!