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DewDiligence

01/09/19 8:31 PM

#223099 RE: CT #223098

RVNC—I do wish that they weren't spending money on PF trials.

It won’t cost that much to find out if RT002 works in PF. If it does, it could facilitate the pursuit of other pain indications.

Dysport was tried in PF without success and RVNC's 2a was unsuccessful…

The new phase-2 trial in PF has design changes relative to the first one; from RVNC’s 1/7/19 PR (#msg-145920782):

The Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled study will evaluate the safety and efficacy of two doses of…(RT002) in reducing the signs and symptoms of plantar fasciitis.

The study is expected to enroll approximately 150 adult patients with unilateral plantar fasciitis, from approximately 20 study centers in the United States. Patients will be randomized (1:1:1) to receive an injection of a low dose, high dose or placebo. The study’s primary efficacy endpoint is the change from baseline in Numeric Pain Rating Scale (NPRS) score at Week 8. Patients will be followed for up to 24 weeks post treatment to assess treatment response, tolerability and safety.

p.s. A successful IST of botulinum toxin in PF was conducted in 2013 (#msg-137500660), so it’s not an insurmountable hurdle.