Revance Therapeutics Initiates BELMONT Phase 2 Active Comparator Trial of Injectable RT002
Specialty biopharmaceutical company Revance Therapeutics,
Inc. has initiated the BELMONT trial, a Phase
2, Randomized, Double-Blind, Dose Ranging, Active and Placebo
Controlled, Multi-Center Study to Evaluate the Safety and Efficacy and
Duration Of Effect of RT002, a Botulinum Toxin Type A for Injection, to
Treat Glabellar Lines, more commonly known as frown lines.
RT002,
incorporating Revance's patented TransMTS(R) delivery technology, is an
investigational product designed to offer more targeted delivery of
botulinum toxin to intended treatment sites with reduced spread beyond
the site of local injection. Last April, Revance reported the results
of a Phase1/2 study which showed median duration of 29.4 weeks, which
exceeds the labeled duration of currently marketed botulinum toxin
products for the treatment of glabellar lines.
"We are very excited about the potential for RT002; our previous dose
escalation study for the treatment of glabellar lines showed compelling
safety, efficacy and duration of effect," said Dan Browne, co-founder,
President and Chief Executive Officer at Revance. "The opportunity for
a longer-lasting, more targeted neurotoxin is tremendous as it offers
the potential for improved patient satisfaction and safety with
longer-lasting results." Mr. Browne added, "Based on the current
progress of our program, we expect to report top-line data from this
Phase 2 study in late 2015, as previously disclosed."
"A product that could last roughly double the duration of commercially
available neurotoxins for the treatment of frown lines, could be a
'game changer' for not only the cosmetic market, but potentially for
other applications as well," commented Jean Carruthers, MD, Clinical
Professor in the Department of Ophthalmology at the University of
British Columbia in Vancouver, an investigator in the BELMONT trial and
leading expert on botulinum toxin who has participated in clinical
trials for over 30 years.
BELMONT Study Design
The BELMONT study will evaluate the safety, efficacy and duration of
three doses of RT002, the labeled dose of the current market leader
BOTOX(R) Cosmetic and a placebo control. BELMONT is expected to enroll
approximately 250 subjects at up to 10 sites in Canada. The primary
endpoints for the study are the investigator's assessment of glabellar
line severity at maximum frown at Week 24 and median duration of effect
from the date of treatment back to baseline severity. Patients in the
BELMONT study will be randomized one-to-one across five study arms
receiving one of three doses of RT002, an active comparator (BOTOX(R)
Cosmetic) or placebo. The RT002 doses will be equal to or greater than
the labeled doses of commercially available products.
Previous RT002
clinical data showed a similar safety profile across escalating doses.
Additional information about the trial, including eligiblity criteria,
can be found at www.clinicaltrials.gov. (Clinical trial identifier
NCT02303002).