Another Durable Botulinum Toxin with Many Advantages
As per its self- described profile, Revance Therapeutics (RVNC) manufactures and develops novel botulinum toxin products for multiple aesthetic and therapeutic indications. The company is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS® peptide delivery system to address unmet needs in the growing markets. Revance’s proprietary TransMTS technology seems to enable delivery of botulinum toxin A through two novel drug product candidates, a needle-free topical form and an injectable form that may localize the drug to the site of injection, resulting in a targeted and potentially long-lasting delivery.
Revance’s product candidates RT001 topical and RT002 injectable are in clinical trials for a broad spectrum of aesthetic and therapeutic indications. The company holds worldwide rights for all indications of RT001, RT002 and the TransMTS technology platform.
In the NEWS
Successful Clinical Trial Results
“The BELMONT study, using some of the top botulinum toxin injectors, was designed to further demonstrate the effectiveness and duration of RT002 versus BOTOX Cosmetic, the current market leader.
Data: Study of injectable RT002 demonstrate Positive 24-week results. The ongoing study for the treatment of glabellar lines in 268 subjects compared the safety, efficacy and duration of effect of three doses of RT002 against placebo and against BOTOX Cosmetic/ VISTABEL®.
The interim data showed that RT002 demonstrated 6-month median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale.
Key interim results of at least 1-point improvement in frown lines for three doses (20 Units, 40 Units and 60 Units) of RT002 was highly statistically significant as compared to placebo for all three doses.
– All doses of RT002 achieved a 100 percent response rate of at least 1-point improvement in frown lines, versus a 95 percent response rate for BOTOX Cosmetic.
– RT002 40U was statistically significant to BOTOX Cosmetic on all three responder definitions for the median duration of effect. RT002 demonstrated a23.6 week median duration versus BOTOX’ 18.8 week median duration.
– More than twice as many RT002 40U and 60U subjects in the study maintained none or mild wrinkles on as compared to BOTOX Cosmetic at Week 16.
RT002 appeared to be generally safe and well-tolerated.
Adverse (AEs) events for RT002: The AEs were generally mild, localized and transient. RT002 20U and 40U caused no ptosis (eyelid droop). There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.
The firm plans to report BELMONT’s final study results and to conduct an End-of-Phase 2 meeting with the FDA in the first half of next year. It expects to begin Phase 3 clinical studies in the second half of 2016.
If the Phase 3 study results are consistent with the currently reported results, the firm believes that the collective data should support a 6-month duration label.
Jean D. Carruthers, MD, Clinical Professor, at University of British Columbia, Medical Director at Jean Carruthers Cosmetic Surgery Inc., a lead investigator for the RT002 BELMONT trial, and one of the world’s foremost leaders in aesthetic botulinum toxin use summarized the subject as follows:
“Revance has done something that has never been done before in a neurotoxin Phase 2 clinical program in terms of demonstrating superior duration of effect in an active comparator study.”
“The 100 percent achievement of at least a 1-point improvement on the Facial Wrinkle Severity Scale seen as early as two weeks in all dose groups is impressive. The 6-month duration makes this a likely game changer in our aesthetic practices. Currently many of my patients come in year after year on a quarterly basis for botulinum toxin injections.”
“With RT002 they could get their botulinum toxin treatments on a bi-annual basis, which conveniently coincides with a large percentage of my patients who receive fillers or other treatments for pan facial uses.”
“Multiple aesthetic and therapeutic indications within the estimated $3 billion global neurotoxin market may benefit from RT002’s solid safety profile and sustained duration, including muscle movement disorders and pain management.”
“Botulinum toxin Type A, combined with Revance Therapeutics’ proprietary TransMTS® peptide technology, provides a significant scientific advancement in neurotoxin therapy that has the potential to meaningfully expand the injectable market.”
Subjects in the BELMONT study were randomized equally across five study groups receiving one of three doses of RT002, the active comparator or placebo. The results today are based on the interim 24-week results, and the trial continues to follow a subset of subjects for up to 36 weeks or until they return to baseline. Additional information about the trial can be found atwww.clinicaltrials.gov, Clinical trial identifier NCT02303002.
Revance management will host a conference call and webcast today at 8:00 am ET. Individuals interested in listening to the conference call today, October 29, at 5:00am PT/8:00 am ET may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 59573766; 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 October 29, 2015 at 8:00 am PT/11:00 am ET through midnight on October 29, 2015.
To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 59573766. 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 Glabellar LinesThe glabella is the skin between the eyebrows and above the nose.
Glabellar lines (often called “frown lines”) are those vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines and may also appear angled towards the inner corners of the eyebrows. When you frown, the muscles of the lower forehead contract in a downward direction causing the skin between the eyebrows to crease. Lines are formed by the repeated action of frowning due to the lack of elasticity in the skin.
Age, sun exposure, and genetics are contributing factors. Botulinum toxin is used to block the nerve impulses, temporarily paralyzing the muscles that cause the frown lines, giving the skin a smoother, more refreshed appearance.
Based on data from UBS Global Research, the global market for aesthetic treatments with neurotoxins represented about a $1.4 million market in 2014 and according to the American Society for Aesthetic Plastic
Surgery, botulinum toxin treatment is the number one nonsurgical cosmetic procedure in the U.S. glabellar line treatment represents the largest segment of that market.
Botox is currently used also in the treatment of diseases, including Migraine, Sciatica, Excessive sweating, Urinary incontinence (overactive bladder), MS and muscle spasms, Tennis elbow, Bell’s palsy and Squint, which is also called crossed eyes.
This news is great for the users and for the firm’s shareholders.
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