Revance Reports Positive Results from ASPEN-1 Phase 3 Trial of DaxibotulinumtoxinA for Injection in Cervical Dystonia
- Trial met primary and all secondary endpoints for both 125- and 250-Unit doses with high statistical significance -
- DaxibotulinumtoxinA for Injection was effective and generally well-tolerated in reducing the signs and symptoms for cervical dystonia, delivering up to a median duration of 24 weeks -
- Results suggest DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually -
- Global market opportunity for cervical dystonia is
- Conference call today at
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This pivotal study enrolled a total of 301 subjects at 60 sites in the
The study met its primary efficacy endpoint at both doses, demonstrating a clinically meaningful improvement in the signs and symptoms of cervical dystonia at the average of Weeks 4 and 6. Compared to placebo, subjects treated with either 125 Units or 250 Units showed a statistically significant greater change from baseline (12.7 and 10.9 respectively vs. 4.3, p<0.0001 and p=0.0006) as measured on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score.
Median duration of effect was 24.0 and 20.3 weeks, for the 125 Unit and 250 Unit dose groups respectively, based on the median time to loss of 80% of the peak treatment effect.
“I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided trial subjects in
“We are very pleased to report these positive results from the
The company expects results from the companion
Positive efficacy results were seen with both DaxibotulinumtoxinA for Injection dose groups studied. The trial’s primary efficacy measurements were based on the average of the change from baseline in TWSTRS Total Score at Weeks 4 and 6. TWSTRS Total Score is a composite score evaluating features of the cervical dystonia condition, including severity, disability and pain:
125 Unit Dose
250 Unit Dose
Average Reduction from Baseline
12.7 (31%, p<0.0001)
10.9 (27%, p=0.0006)
(% change from baseline, p-value vs. placebo)
The median duration of effect was 24.0 weeks for the 125 Unit dose, and 20.3 weeks for the 250 Unit dose, as measured by the time to loss of 80% of the peak treatment effect.
Two of the secondary endpoints measured the percentage of responders showing improvement with at least a 2-point improvement based on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) at Week 4 or 6. Both the clinician and patient results were consistent and showed a statistically significant improvement greater than placebo (p<0.001).
SAFETY RESULTS: In both dose groups, DaxibotulinumtoxinA for Injection appeared to be generally safe and well-tolerated through Week 36. There were no serious treatment-related adverse events and no dose-dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity, with one case of neck pain reported as severe, which resolved two days after onset. The three most common treatment-related adverse events were (for 125 Units and 250 Units):
- Injection site pain (7.9%, 4.7%)
- Headache (4.7%, 4.7%)
- Injection site erythema (4.7%, 2.3%)
The incidence of dysphagia (difficulty swallowing) and muscle weakness, which are considered adverse events of particular interest with botulinum toxin treatments for cervical dystonia, was encouragingly low: dysphagia (1.6%, 3.9%) and muscular weakness (4.7%, 2.3%).
In 2017, the
Randomized Trial (
Open-Label Study (
Additional information about the
About Cervical Dystonia
According to the
First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in
The company plans to host a conference call to discuss the results today at
Individuals interested in listening to the conference call may do so by dialing 1(855)453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1987683; or from the webcast link in the investor relations section of the company’s website at: www.revance.com. A replay of the call will be available beginning
The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.
“Revance Therapeutics” and the Revance logo are registered trademarks of
Resilient Hyaluronic Acid® and RHA® are trademarks of
BOTOX® is a registered trademark of
Any statements in this press release that are not statements of historical fact, including statements about DaxibotulinumtoxinA potential for the treatment of cervical dystonia; its therapeutic and commercial potential; the timing and results of the
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that the top-line results from the
Jenifer Slaw, 347-971-0906
Nadine Tosk, 504-453-8344