Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company
developing botulinum toxin products for use in aesthetic and
therapeutic indications, today reported results from its REALISE 1
Phase 3 trial of DaxibotulinumtoxinA Topical Gel (RT001) to treat
patients with moderate to severe lateral canthal lines, or crow’s
feet.
In REALISE 1, DaxibotulinumtoxinA Topical Gel
(RT001) did not achieve its co-primary and other endpoints. The
co-primary efficacy endpoints in the trial were composite
measurements of 2-point or greater and 1-point or greater
improvement in lateral canthal lines between baseline and 28 days
after treatment, as graded by the Investigator’s Global Assessment
of Lateral Canthal Lines (IGA-LCL) and the Patient Severity
Assessment (PSA). RT001 topical generally appeared to be
well-tolerated in this study.
“We are disappointed with the results of the
REALISE 1 trial. The data was unambiguous, and we do not plan to
continue development of RT001 topical for crow’s feet. Based on
these results, we have also decided not to pursue the current
clinical development plan for RT001 in axillary
hyperhidrosis. We are grateful to all the patients and
investigators for their participation in the REALISE 1 trial,” said
Dan Browne, President and Chief Executive Officer at Revance.
“Given the positive results in our recent Phase 2 BELMONT active
comparator trial, we will focus our future development efforts and
financial resources on DaxibotulinumtoxinA for Injection
(RT002).”
Mr. Browne continued, “Looking ahead to the second
half of this year, we remain on track to initiate RT002 injectable
Phase 3 clinical trials for glabellar lines and report interim
Phase 2 results in cervical dystonia. We recently held an
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) regarding our RT002 injectable program for glabellar lines.
We believe the meeting was informative and productive. Meeting
minutes are in process, and consistent with company and industry
practice, we look forward to providing further updates when we have
final minutes from the FDA.”
At the end of March 2016, Revance had cash and
investments of $236.6 million. Based on its current development
plans, the company now expect its cash and investments to fund its
operations into the second quarter of 2018.
Phase 3 Trial Design – REALISE
1The Phase 3 trial was a randomized, double-blind,
parallel-group, placebo-controlled study to evaluate the safety and
efficacy of DaxibotulinumtoxinA Topical Gel (RT001) for the
treatment of moderate to severe lateral canthal lines. A
total of 450 adult patients were enrolled at seven sites in the
United States and were randomized 1:1 to a single treatment of
either RT001 or placebo topical gel applied to lateral canthal
lines on both sides of the face using Revance’s proprietary
applicator.
DaxibotulinumtoxinA for Injection (RT002)
Pipeline ProgramsPlanned Phase 3 Program for the
Treatment of Glabellar (Frown) Lines - In the BELMONT
Phase 2 Active Comparator Study for the treatment of glabellar
lines, Revance’s RT002 injectable achieved 6-month median duration
of effect for the 40-unit dose, showed a statistically
significantly greater duration than the study comparator, BOTOX®
Cosmetic, and appeared to be safe and well-tolerated. The company
plans to initiate a Phase 3 program in the second half of 2016.
Phase 2 Trial for the Treatment of Cervical
Dystonia - Revance’s Phase 2 dose-escalating study of
RT002 injectable for the treatment of cervical dystonia is
enrolling patients into Cohort 2, following the encouraging,
preliminary results from a planned six-week safety review for
patients enrolled in Cohort 1 (n=12) of the study. Revance expects
to share interim results from this study in the second half of
2016.
Conference Call Revance management
will host a conference call and webcast today, June 13, at 1:30 pm
PDT/ 4:30 pm EDT. Individuals interested in listening to the
conference call may do so by dialing (855) 453-3827 for domestic
callers, or (484) 756-4301 for international callers and reference
conference ID: 32469026; 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
June 13, 2016 at 4:30 pm PDT/ 7:30 pm EDT through midnight on June
14, 2016. To access the replay, dial (855) 859-2056 or (404)
537-3406 and reference conference ID: 32469026. The webcast will be
available in the investor relations section on the company's
website for 30 days following the completion of the call.
About Revance Therapeutics, Inc.
Revance, a Silicon Valley-based biotechnology
company, is committed to the advancement of remarkable
science. The company is developing a portfolio of products
for aesthetic medicine and underserved therapeutic specialties,
including dermatology and neurology. Revance’s trajectory to
commercial success begins with the company’s novel and proprietary
TransMTS® carrier-peptide delivery system applied to botulinum
toxin.
Revance is developing daxibotulinumtoxinA, the
company’s highly purified botulinum toxin, for a broad spectrum of
aesthetic and therapeutic indications, including facial wrinkles
and muscle movement disorders.
The company holds worldwide rights for all
indications of DaxibotulinumtoxinA Topical Gel (RT001),
DaxibotulinumtoxinA for Injection (RT002) and the TransMTS
technology platform. Beyond botulinum toxin, Revance believes
the TransMTS technology can be applied to transdermal, mid-dermal,
or deep tissue delivery of a variety of other macromolecules.
More information on Revance can be found at www.revance.com.
"Revance Therapeutics", TransMTS®, “Remarkable
Science Changes Everything”, and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
BOTOX® is a registered trademark of Allergan,
Inc.
Forward Looking Statements This
press release contains forward-looking statements, including, but
not limited to: statements about our business strategy, our
investigational drug product candidates, expected efficacy of our
drug product candidates, clinical development, timeline and other
goals and market for our anticipated products, plans and prospects
and statements about potential benefits of our drug product
candidates and our technologies.
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 clinical trials may
not have an effective design or generate positive results; our
ability to obtain and maintain regulatory approval of our drug
product candidates; our ability to obtain funding for our
operations; our plans to research, develop, and commercialize our
drug product candidates; our ability to achieve market acceptance
of our drug product candidates; unanticipated costs or delays in
research, development, and commercialization efforts; the
applicability of clinical study results to actual outcomes; the
size and growth potential of the markets for our drug product
candidates; our ability to successfully commercialize our drug
product candidates and the timing of commercialization activities;
the rate and degree of market acceptance of our drug product
candidates; our ability to develop sales and marketing
capabilities; the accuracy of our estimates regarding expenses,
future revenues, capital requirements and needs for financing; our
ability to continue obtaining and maintaining intellectual property
protection for our drug product candidates; and other risks.
Detailed information regarding factors that may cause actual
results to differ materially from the results expressed or implied
by statements in this press release may be found in Revance's
periodic filings with the Securities and Exchange
Commission (the "SEC"), including factors described in the
section entitled "Risk Factors" of our quarterly report on Form
10-Q filed on May 10, 2016. These forward-looking statements speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
Contacts
Investors:
Revance Therapeutics
Jeanie Herbert
(714) 325-3584
jherbert@revance.com
Burns McClellan
Ami Bavishi
(212) 213-0006
abavishi@burnsmc.com
Trade Media:
Nadine Tosk
(504) 453-8344
nadinepr@gmail.com
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