Sol-Gel's Acne Treatment Found Effective
The top-line results from two pivotal Phase 3 trials for Twyneo showed statistically significant improvement on all co-primary endpoints in the treatment of patients with acne vulgaris, Sol-Gel said.
Twyneo is a combination of microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream.
"We are excited to share these robust results which further demonstrate the potential of our microencapsulation technology to deliver first-of-its kind efficacy in a topical acne treatment," Dr. Alon Seri-Levy, CEO of Sol-Gel, said in a statement.
Sol-Gel Plans NDA Filing In Second Half Of 2020
The company said it expects to submit an NDA for the investigational asset in the second half of 2020, with commercialization in the second half of 2021.
"The data presented today show that this unique formulation offers superior efficacy without compromising tolerability in a very convenient treatment. I believe physicians will look forward to adding Twyneo to their acne treatments toolbox," Hilary Baldwin, a clinical dermatologist and researcher, said in the Sol-Gel press release.
Twyneo was found to be well-tolerated, with the majority of reported local skin reactions being mild and showing improvement over time, according to the company.
The stock was trading 83.53% higher to $16.94 at the time of publication.
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