REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Files An 8-K Regulation FD Disclosure
ITEM7.01
| REGULATION FD DISCLOSURE. |
As reported under Item 8.01 of this current report on Form
8-K, Revance
Therapeutics, Inc. (the Company) issued a press release on
December12, 2016 announcing positive results from its Phase 2
open-label, dose-escalating clinical study to evaluate the safety
and preliminary efficacy of its investigational drug product
candidate, DaxibotulinumtoxinA for Injection (RT002) for the
treatment of cervical dystonia, a muscle movement disorder.
During a conference call and webcast scheduled to be held at 4:30
PM Eastern Time on December12, 2016, Company management will
discuss the results from the study. The slide presentation for
the conference call and webcast is furnished as Exhibit 99.1
hereto and is incorporated by reference herein. A copy of the
press release is furnished as Exhibit 99.2 hereto and is
incorporated by reference herein.
The furnishing of
the attached presentation is not an admission as to the
materiality of any information therein. The information contained
in the slides is summary information that is intended to be
considered in the context of more complete information included
in the Companys filings with the Securities and Exchange
Commission (the SEC) and other public announcements that the
Company has made, including the press release furnished as
Exhibit 99.2 hereto, and may make from time to time by press
release or otherwise.
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 Section18 of the Securities 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.
ITEM8.01 |
OTHER EVENTS |
On December12,
2016, the Company announced positive results from its Phase 2
open-label, dose-escalating clinical study to evaluate the safety
and preliminary efficacy of RT002 injectable for the treatment of
cervical dystonia. The topline interim data showed that RT002
injectable appeared to be generally safe and well-tolerated,
demonstrated median duration of 24 weeks, and displayed
clinically significant impact on cervical dystonia signs and
symptoms. The trial enrolled 37 subjects and follows three
sequential treatment cohorts for up to a total of 24 weeks after
treatment for each cohort. The trials first cohort of 12 subjects
received a single dose of up to 200 units of RT002 injectable,
the second cohort of 12 subjects received between 200 and 300
units, and the third cohort received from 300 to 450 units.
Later-enrolled subjects in the second and third cohorts have yet
to complete the trials 24-week protocol. Todays results are
therefore preliminary, with final results expected in the first
half of 2017.
Key interim
results of the cervical dystonia trial are as follows:
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SAFETY: In all three cohorts, RT002 injectable appeared to be generally safe and well-tolerated. There were no serious adverse events and no dose-dependent increase in adverse events. The treatment-related adverse events were transient and mild to moderate in severity, except for one case of neck pain reported as severe, with a duration of 2 days. The most common adverse events were dysphagia, or difficulty in swallowing (10.8%), injection site redness (8.1%), injection site pain (5.4%), muscle tightness (5.4%) and muscle weakness (5.4%). For reference, trials for botulinum type A products approved to treat cervical dystonia have adverse events for dysphagia ranging from 13% to 39%. |
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EFFICACY: The trials 4-week primary efficacy measurement was the improvement in dystonia symptoms as determined by reduction from baseline on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score. RT002 injectable showed a clinically significant mean reduction of 16.9 from baseline, or 38%, across all three cohorts. In cohort one, with a mean dose of 174 units, the majority of the 44% reduction observed in the TWSTRS-Total score at Week 4 was preserved at Week 24, with a 33% mean reduction from baseline observed. Clinically meaningful mean reductions in the TWSTRS Severity, Disability and Pain subscales were consistent and observed at all follow-up visits in the first cohort. Later-enrolled subjects in the second and third cohorts have not yet reached the 24-week point. For reference, placebo-controlled trials with botulinum type A products approved to treat cervical dystonia had a reduction in the TWSTRS-Total score from baseline of 14% to 26% at Week 4. |
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DURATION OF EFFECT: Duration of effect for this trial was defined as the number of weeks from treatment until the return of symptoms that warrant retreatment, based on the subjects target TWSTRS score. The median duration of effect was at least 24 weeks for subjects in cohort one (n=12), and at least 16 weeks for subjects in cohort two (n=11), using the complete 16 week follow up data. In cohort one, no subjects had returned to baseline at Week 24 and only one subject in cohort two, to date, has returned to baseline, which occurred at the Week 24 visit. In cohort one, RT002 achieved a median duration of at least 24 weeks based on three different assessments, including 1) the number of weeks from treatment until a subject reaches or exceeds their target TWSTRS-Total score, 2) improvement (score 0) on the Clinician Global Impression of Change (CGIC), and 3) TWSTRS-Total score return to baseline. For reference, current treatment of cervical dystonia calls for injection of botulinum toxin approximately every 3 months, or 4 times per year. |
The Company also
has recently enrolled patients in its Phase 3 SAKURA clinical
trial of RT002 injectable for the treatment of moderate to severe
glabellar lines in adults and initiated a Phase 2
placebo-controlled trial of RT002 injectable for the management
of plantar fasciitis. Results for both studies are expected in
2017.
ITEM9.01 |
FINANCIAL STATEMENTS AND EXHIBITS |
(d) |
Exhibits. |
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| 99.1 | Company slide presentation dated December12, 2016. | |
| 99.2 | Press Release dated December12, 2016. |
About REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC)
Revance Therapeutics, Inc. is a biotechnology company. The Company is focused on the development, manufacturing and commercialization of botulinum toxin products for multiple aesthetic and therapeutic indications. Its TransMTS technology enables delivery of botulinum toxin type A through investigational drug product candidates, including DaxibotulinumtoxinA Topical Gel (RT001), or RT001 topical, and DaxibotulinumtoxinA for Injection (RT002), or RT002 injectable. Its botulinum toxin-peptide complex has over two components that contribute to the performance of RT001 and RT002. Its TransMTS peptide provides the delivery across the skin and restricts the toxin molecule to the target site. Then, the botulinum toxin type A provides the mechanism of pharmacologic action and is responsible for the drug effects demonstrated in its clinical trials. Its TransMTS peptide technology serves various purposes depending on whether it is used in a topical formulation or in an injectable formulation. REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) Recent Trading Information
REVANCE THERAPEUTICS, INC. (NASDAQ:RVNC) closed its last trading session down -1.25 at 16.15 with 175,960 shares trading hands.