Topline results from the pivotal trial of Sienna Biopharmaceuticals’ SNA-001 show that the topical agent in conjunction with an 810nm diode laser was statistically superior compared to vehicle plus laser. In the study involving 65 male and female patients with white, gray, blonde, light red and light brown hair, SNA-001 demonstrated up to a 31 percent reduction of light hair from baseline.
The data show that SNA-001 met the primary endpoint of non-inferiority in hair reduction (-17.5 percent with SNA-001+ laser compared to -1.1 percent with vehicle + laser following six treatment sessions).
“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,” says Frederick C. Beddingfield III, MD, PhD, 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 3 development of SNA-120, our TrkA2 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.”
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 major breakthrough in laser hair removal in over a decade. Sienna’s silver photoparticle technology, combined with the lasers we already have in our offices, showed a meaningful reduction in light hair – something we have never achieved before,” said Mathew Avram, MD, JD Director, Massachusetts General Hospital Laser, Cosmetics & Dermatologic Surgery Associate Professor, Harvard Medical School. “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 1064nm Nd:YAG and 755nm 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 + laser group compared to the 810nm 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.