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16:08 Revance doses first patient in Phase 3 RT002 program for CD treatment


Revance Therapeutics announced initiation of patient dosing in the company's ASPEN Phase 3 clinical program for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a movement disorder of the neck. Positive results from the company's open-label, dose-escalating Phase 2 clinical study of RT002 injectable in the treatment of cervical dystonia were recently published in Movement Disorders Clinical Practice.

The trial demonstrated a median duration of effect of at least 24 weeks for each of the three dose cohorts studied. For reference, current treatment of cervical dystonia calls for injection of botulinum toxin approximately every three months, or four times per year. The Phase 2 trial achieved its primary efficacy endpoint, demonstrating a clinically significant mean reduction of 38% in the Toronto Western Spasmodic Torticollis Rating Scale - Total score from baseline at Week 4 across all three cohorts.

This mean reduction continued to increase to 50% at Week 6, 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. The global neuromodulator opportunity for muscle movement disorders in 2017 was estimated to be more than $1 billion. The company plans to initiate a Phase 2 program in upper limb spasticity, the largest indication in the muscle movement segment, later this year.

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