Preliminary results from a Phase 2 clinical trial assessing Revance Therapeutics' (NASDAQ:RVNC) lead product candidate DaxibotulinumtoxinA for Injection (RT002) for the treatment of adults with moderate-to-severe isolated cervical dystonia showed a positive and durable treatment effect.
The 37-subject study features three cohorts delineated by dose. All patients are being followed for 24 weeks after the four-week treatment period.
Efficacy was measured by the change from baseline in the total score of a scale called TWSTRS. Treatment with RT002 produced a 38% average reduction in TWSTRS score across all three cohorts. In cohort 1 (mean dose of 174 units) the average reduction was 44% at the end of the treatment period but eased a bit to 33% 24 weeks later.
The mean duration of effect was at least 24 weeks in cohort 1 and at least 16 weeks in cohort 2. RT002 was generally safe and well-tolerated across the three groups.
Final results should be available in H1 2017.
The current treatment for cervical dystonia is an injection of botulinum toxin every three months.
RT002 is also being developed to treat frown lines.
The FDA approves privately held Galderma's Restylane Refyne for the treatment of adults with moderate-to-severe facial wrinkles and folds and Restylane Defyne for the treatment of adults with moderate-to-severe deep facial wrinkles and folds.
The injectable gels are manufactured with the company's XpresHAn technology which it says offers a range of flexibility and support in the way they smooth away nasolabial folds (laugh lines).
The products were approved in Europe in 2010 under the brand name Emervel.
Subject dosing is underway in Revance Therapeutics' (RVNC -5.5%) Phase 3 SAKURA program assessing DaxibotulinumtoxinA for Injection (RT002) for the treatment of moderate-to-severe glabellar lines (frown lines) in adults. Top-line data should be available in Q4 2017.
SAKURA includes two randomized, double-blind, placebo-controlled pivotal studies to evaluate the safety and efficacy of a single injection of RT002 in a total of~600 participants. The primary efficacy endpoint is a composite of the proportion of subjects who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity as measured by two scales called IGA-FWS and PFWS. SAKURA also includes a long-term open-label safety study that will follow subjects for up to 84 weeks.
Thinly traded micro cap Revance Therapeutics (NASDAQ:RVNC) slumps 6% after hours on higher-than-average volume in apparent response to its announcement that it completed its Type B/pre-IND/pre-Phase 3 meeting with the FDA regarding the advancement of RT002 (daxibotulinumtoxinA for injection) for the treatment of glabellar (frown) lines. Clinical trials should commence in H2.
The Phase 3 program will include two placebo-controlled pivotal studies in the U.S. and Canada. The primary endpoint will be a composite of the proportion of patients who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity at maximum contraction at week 4. The program will also include a long-term open-label safety study. The prospective timeline appears to have disappointed investors.
In a Phase 2 trial, RT002 beat Allergan's (NYSE:AGN) BOTOX Cosmetic.