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Revance reports additional 'positive' week 24 efficacy results from RT002 trial

Revance Therapeutics announced additional clinical results from its U.S. Phase 2 open-label, dose-escalating clinical study of DaxibotulinumtoxinA Injectable to treat moderate-to-severe isolated cervical dystonia, a movement disorder of the neck, in adults.

A late-breaking poster including these data was displayed today and will be presented on Wednesday, June 7, 2017, at 1:15 pm PT in Vancouver, Canada, by study investigator Cynthia L. Comella, MD, Professor in the Department of Neurological Sciences at Rush University Medical Center, Chicago, Illinois.

These results are in addition to findings reported on May 18, 2017, which showed RT002 injectable to be generally safe and well-tolerated. The previously reported findings also demonstrated duration of effect of at least 24 weeks and that RT002 injectable delivered clinically significant improvement in signs and symptoms of cervical dystonia as determined by reduction of the Toronto Western Spasmodic Torticollis Rating Scale - Total score from baseline.

The study researchers analyzed efficacy results in two dose groups: Dose Group A, individuals who received 100 to 240 units of RT002 injectable, and Dose Group B, receiving 300 to 450 units. Median duration of effect, defined as the number of weeks subjects maintained at least 20% of the treatment benefit achieved at Week 4, was greater than 24 weeks for both dose groups, consistent with the greater than or equal to 24-week duration of effect previously reported in each of the trial's three pre-specified patient cohorts. RT002 injectable showed a clinically significant mean reduction of the TWSTRS-Total score from baseline at Week 4 - the primary efficacy endpoint - in both Group A and Group B, with the majority of this benefit maintained through Week 24. In addition, clinically meaningful reductions in TWSTRS-Severity, Disability and Pain subscales were consistent and observed at all time points through Week 24.

A high rate of response was observed in the study, with 94% of subjects at Week 6 experiencing a reduction of at least 20% from baseline in TWSTRS-Total Score, and 68% of subjects at week 24 observed to maintain this treatment benefit at Week 24. In addition, a mean reduction of 37% from baseline in the Cervical Dystonia Impact Profile score was observed at Week 6 for all subjects, with the majority of this clinically meaningful benefit maintained through Week 24. As previously reported, RT002 injectable appeared to be generally safe and well-tolerated through Week 24 in all treatment groups evaluated.

There were no serious adverse events and no dose-dependent increase in adverse events. The treatment-related adverse events were generally transient and mild to moderate, with one case of neck pain reported as severe.

Read more at:
http://thefly.com/landingPageNews.php?id=2562241