Sienna Biopharmaceuticals, Inc. a clinical-stage biotechnology company, announced positive topline results from its pivotal trial of SNA-001 in conjunction with an 810 nanometers diode laser, involving 65 patients. SNA-001, a topical pre-treatment to standard laser hair removal, was studied in women and men with white, gray, blonde, light red, and light brown hair. The data showed SNA-001 met the primary endpoint of non-inferiority in hair reduction (-17.5 percent with SNA-001 plus laser, compared to -1.1 percent with vehicle plus laser following six treatment sessions). In additional analyses, SNA-001 was statistically superior compared to vehicle plus laser, demonstrating up to a 31 percent reduction of light hair from baseline.
“SNA-001 represents an exciting growth opportunity for the aesthetics market and a potential solution for consumers with light hair who are well aware of the ineffectiveness of laser hair removal,” said Frederick C. Beddingfield III, M.D., Ph.D., president and chief executive officer of Sienna Biopharmaceuticals. “We are pleased with these results and will seek a strategic partner who can rapidly maximize the value of SNA-001. This will allow us to remain focused on our phase three development of SNA-120, our TrkA inhibitor for psoriasis and pruritus, and to unlock the full potential of our Topical by Design platform, from which we are creating a pipeline of drug candidates that target select pathways in specific tissues to treat a variety of chronic inflammatory and immunologic conditions.”
Available for nearly 25 years, laser hair removal is one of the most commonly performed aesthetic procedures in the world. With more than 12 million procedures performed annually in the United States, countless patients have benefitted from the lasting results, except for those with light hair. Of the 53 million people who use laser treatments, waxing, and other methods to remove unwanted hair, one in three are light haired. People with white, gray, blonde, and red hair – for whom lasers are ineffective – have been limited to using waxing and razors to remove their unwanted light hair, which yield temporary results and, in the case of waxing, can be costly to maintain. Market data indicate that a safe and effective treatment for people with light hair could increase the number of laser hair removal procedures by 27 percent in the United States.
“This represents the first breakthrough in laser hair removal in over a decade,” said Mathew Avram, M.D., J.D., director at Massachusetts General Hospital Laser and cosmetics and dermatologic surgery associate professor at Harvard Medical School. “Sienna’s silver photo particle technology, combined with the lasers we already have in our offices, showed a meaningful reduction in light hair – something we have never achieved before. If cleared by FDA, SNA-001 would allow physicians and aesthetic centers to expand their current practices by bringing in new patients with blonde, gray, white, light brown, or light red hair who have resorted to waxing and shaving. Once available, I would anticipate rapid and widespread adoption of SNA-001.”
SNA-001 was also evaluated in conjunction with a 1064 Nd:YAG and 755 nm Alexandrite laser for the reduction of light hair, showing a significant reduction from baseline and providing a potential path to regulatory clearance. These results, however, were less differentiated from the vehicle plus laser group compared to the 810 nanometer diode laser study results.
A third and final pivotal trial of SNA-001 in acne was also completed, demonstrating SNA-001 was non-inferior to laser therapy and providing a potential path to regulatory clearance.