SECURITIES AND EXCHANGE COMMISSION
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|ITEM 7.01|| |
REGULATION FD DISCLOSURE
Revance Therapeutics, Inc. (“Revance” or “the Company”) issued a press release on October 14, 2020, announcing topline results from its ASPEN-1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
During a conference call and webcast scheduled to be held at 5:30 a.m. Pacific Time on October 14, 2020, the Company management will discuss the results from the study. The slide presentation for the conference call and webcast is furnished as Exhibit 99.2 hereto and is incorporated by reference herein.
The information in this Item 7.01 of this current report on Form 8-K and Exhibits 99.1 and 99.2 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
|ITEM 8.01|| |
On October 14, 2020, the Company announced positive topline results from its ASPEN-1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a chronic and debilitating neurologic condition affecting the neck muscles.
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. 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 in TWSTRS Total Score
(% change from baseline, p-value vs. placebo)
|12.7 (31%, p<0.0001)||10.9 (27%, p=0.0006)||4.3 (12%)|
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).
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, respectively:
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 low: dysphagia (1.6% and 3.9%) and muscular weakness (4.7% and 2.3%), for 125 Units and 250 Units, respectively.
|ITEM 9.01|| |
FINANCIAL STATEMENTS AND EXHIBITS
|99.1||Press Release dated October 14, 2020|
|99.2||Revance Therapeutics, Inc. Investor Presentation|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: October 14, 2020||Revance Therapeutics, Inc.|
|Tobin C. Schilke|
|Chief Financial Officer|