Biotech Values

[DewDiligence]

RVNC starts phase-3 trial of topical botulinum toxin in crows feet, the lead indication for the topical product:

http://finance.yahoo.com/news/revance-therapeutics-initiates-phase-3-200200859.html

Revance Therapeutics, Inc…today announced it has commenced dosing patients in the Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of lateral canthal lines, or crow's feet… The company plans to release interim results from this Phase 3 study in the first half of 2016.

…The Phase 3 trial is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of RT001, also referred to as RTT150 (Botulinum Toxin Type A) Topical Gel, for the treatment of moderate to severe lateral canthal lines. A total of up to 450 adult patients will be enrolled at multiple sites in the United States and will be randomized 1:1 to a single treatment of either RT001 topical gel or placebo. The product will be applied to lateral canthal lines on both sides of the face using Revance's proprietary applicator.

The primary efficacy endpoints are composites based upon the Investigator's Global Assessment of Lateral Canthal Lines (IGA-LCL) assessment and the Patient Severity Assessment (PSA) between baseline and 28 days after treatment.

One composite endpoint includes those patients with a 2-point or greater improvement as graded by the investigator's assessment and the patient's self-assessment. The other composite endpoint includes those patients who experience a 1-point or greater improvement in the investigator's and patient's assessments.

RVNC is also conducting a phase-2 trial of RT001 in hyperhidrosis (#msg-116856602).

A phase-2 trial of RT002 (RVNC’s injected botulinum toxin) is underway in glabeller lines (#msg-109610207) with data expected by year-end (#msg-111337438).