Biotech Values

[DewDiligence]

RVNC 3Q16 CC notes:


• Phase-3 program in glabellar lines: There will be two identical placebo-controlled efficacy studies with 400 patients each, conducted at approximately 50 sites in the US and Canada. Thus, each site needs to enroll only 16 patients on average, enabling enrollment to be completed quickly. (There is no shortage of people interested in enrolling in a cosmetic-improvement trial.) RVNC expects to report top-line data in 4Q17 (which seems a tad optimistic, IMO).

The phase-3 program in glabellar lines also includes an open-label safety study with 1,500 patients that will follow patients for 12 months and two treatments.

(The general outline of the glabellar–lines phase-3 program was previously disclosed, but today was the first time RVNC revealed info on the trial sites and the number of patients.)


• Phase-2 program in cervical dystonia: The first two dosing cohorts (200U and 300U, respectively) are completed; safety and efficacy data from these two cohorts will be reported during 2016.

The third cohort is testing 450U, and enrollment is almost complete. (Data from the third cohort will be reported in 2017.) The fact that the 450U cohort is enrolling implies that there were no consequential safety issues in the 200U and 300U cohorts.

(Note the large magnitude of the doses used in cervical dystonia, which are 5x-11x the 40U dose used in glabellar lines; this is why cervical dystonia is a highly lucrative market for botulinum toxin products.)


• Phase-2 program in plantar fasciitis: The existence of this program was announced today (#msg-126280882). The PoC trial will be placebo-controlled and will enroll 60 patients at a single trial site in the US. Each patient will receive one treatment (consisting of multiple foot injections in a single session) and will be followed for 16 weeks.

If this PoC trial works, RVNC may pursue other pain indications, particularly those covered by the IP estate acquired from BTRX (#msg-123060641).


• Financial info: See #msg-126301216.