Revance Therapeutics commenced a pair of double-blind, placebo-controlled, North American Phase 3 trials to evaluate single injections of drug candidate DaxibotulinumtoxinA (RT002) for the treatment of glabellar lines in about 600 total patients. The trials follow the successful BELMONT study that showed RT002 delivered six-month duration of effect, with no ptosis at the 40-unit level, in treating frown lines.
The company also initiated a placebo-controlled Phase 2 trial of RT002 to treat plantar fasciitis. It will evaluate the safety and efficacy of a single administration of the drug in reducing the signs and symptoms of plantar fasciitis. Revance expects to report results in 2017.
Interim results from Revance’s Phase 2 open-label, dose-escalating clinical study of RT002 for moderate to severe cervical dystonia are now available. The data reported on cohort 1 (up to 200 units) for the full 24-week trial, cohort 2 (200 to 300 units) at 16 weeks and cohort 3 (300 to 450 units) at four weeks. The injectable demonstrated a clinically significant mean reduction of 16.9 (38%) from baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score across all three cohorts at week 4. In cohort one, RT002 achieved a median duration of at least 24 weeks based on three different assessments, including: the number of weeks from treatment until a subject reaches or exceeds their target TWSTRS total score; improvement (score >0) on the Clinician Global Impression of Change (CGIC); and TWSTRS total score return to baseline. RT002 delivered a strong safety profile in all cohorts with no serious adverse events and no dose-dependent increase in adverse events.