Biotech Values

[DewDiligence]

RVNC reports more phase-2 data in CD—(see bottom for link to CC slides):

https://www.businesswire.com/news/home/20170518006294/en

Revance Therapeutics…today announced duration of effect of at least 24 weeks in its U.S. Phase 2 open-label, dose-escalating clinical study of DaxibotulinumtoxinA Injectable (RT002) to treat moderate-to-severe isolated cervical dystonia, a movement disorder of the neck, in adults. The company also announced additional positive efficacy results and that RT002 was generally safe and well-tolerated.

TOP-LINE 24-WEEK RESULTS

• DURATION OF EFFECT AT LEAST 24 WEEKS: The median duration of effect was at least 24 weeks for each of the three dose cohorts studied. Duration of effect was defined as the number of weeks from treatment until the return of signs and symptoms that warrant retreatment, based on subjects reaching their target Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score. For reference, current treatment of cervical dystonia calls for injection of botulinum toxin approximately every 3 months (12 weeks), or 4 times per year.

• POSITIVE EFFICACY RESULTS: The trial’s 4-week primary efficacy measurement was the improvement in signs and symptoms of cervical dystonia as determined by reduction of the TWSTRS-Total score from baseline. At Week 4, RT002 injectable showed a clinically significant mean reduction of 38% from baseline across all three cohorts. This reduction continued to increase to 50% at Week 6 for all subjects, was 42% at Week 12 and was maintained at or above 30% through Week 24. For reference, placebo-controlled trials for botulinum toxin type A products approved to treat cervical dystonia had a reduction in the TWSTRS-Total score from baseline of 21% to 26% at Week 4 and 13% to 16% at Week 12.

…Based on these Phase 2 results, the company expects to discuss next steps in this clinical program with the US and EU regulatory agencies later this year.

CC at 4:30pm ET—these are the CC slides:
http://investors.revance.com/common/download/download.cfm?companyid=AMDA-2GNRV0&fileid=943515&filekey=5F1AE320-5FE5-4FFC-9E62-85DF1EA5CBE9&filename=Phase_2_Cervical_Dystonia_W24_PR_Slides.FINAL-2.pdf