Revance Therapeutics, Inc. ("Revance") today announced that the results of two Phase 2b clinical trials on RT001, a topical botulinum toxin type A which is under investigation for the treatment of lateral canthal lines (crow's feet wrinkles) were presented at the annual meeting of the American Society of Dermatologic Surgery in Chicago. Both multi-center, double-blind, randomized, controlled studies showed that RT001 was well tolerated and demonstrated statistically significant efficacy versus controls. Adverse events were unrelated to study treatment as rated by the investigators and generally mild or moderate, and transient. There was no evidence of spread or diffusion away from the target muscle observed.
“These data confirm that large proteins such as botulinum toxin type A don't have the ability to cross skin by themselves.”
The first study enrolled 90 subjects and utilized a primary composite endpoint that included ratings by both the investigator and the patient on validated wrinkle severity scales. To be a responder, each subject had to demonstrate a ≥2-point improvement on both sides of the face as graded by the investigator's assessment and the patient's self-assessment. RT001 met the primary endpoint and all secondary endpoints with p≤0.0001. "A treatment that shows such promising results should appeal to a wide variety of new patients, many of whom do not like having a needle so close to their eyes and have been hesitant to come in for a cosmetic procedure," said Fredric Brandt, MD, a dermatologist in private practice in New York and Miami and the principal investigator of the study.
The second study had 180 subjects and was designed to compare the individual components comprising RT001. These components include botulinum toxin type A, the proprietary peptide carrier and the vehicle. RT001 met the primary endpoint of ≥2-point improvement in lateral canthal line severity on both sides of the face as measured by the investigator. The results were statistically significant (p&0.0001) compared to each component of RT001 individually and all the components combined. RT001 also met the more stringent composite endpoint of ≥2-point improvement on both the investigator assessment and the patient's self assessment compared to controls (p&0.0001). These results suggest that the peptide carrier is necessary for topically applied botulinum toxin to achieve positive results.
"The results of this study are very exciting," said Robert Weiss, MD, Director of the Maryland Laser, Skin & Vein Institute and Associate Professor of Dermatology at Johns Hopkins who was one of the investigators who presented data today. "These data confirm that large proteins such as botulinum toxin type A don't have the ability to cross skin by themselves."
Gary Monheit, MD, Clinical Associate Professor at the University of Alabama also presented the overall results of the Phase 2 program in a session dedicated to "Advances in Botulinum Toxins."
Revance has done extensive development work on RT001 for lateral canthal lines and has completed 11 clinical trials and treated more than 550 subjects. The company was originally scheduled for an end-of-phase 2 meeting with the FDA earlier this month. The meeting did not take place as the Agency continues the review of the end-of-phase 2 briefing package submitted in September.
"We are pleased by the results generated in the RT001 clinical program," said Dan Browne, President and CEO of Revance. "We developed a robust testing program and RT001 continues to exceed our expectations. We will continue to provide information as the Agency requests in a timely manner as we move forward with the program."
Fish oil speeds muscle recovery in aging rats, suggesting potential benefits for humans