(Reuters) – Sol-Gel Technologies Ltd’s shares more than tripled in value on Monday after the company said its lead acne drug candidate, Twyneo, met the main goal of reducing marks in two late-stage studies.
Twyneo is a once-daily topical non-antibiotic cream containing a fixed-dose combination of encapsulated benzoyl peroxide and tretinoin.
The late-stage studies evaluated Twyneo in 858 patients aged nine and above with moderate to severe acne when applied once daily for 12 weeks. Neither studies reported drug-related serious adverse events.
Acne is a common skin disease that affects about 40 million to 50 million people in the United States, according to the American Academy of Dermatology.
Benzoyl peroxide and tretinoin have been widely used separately historically to treat acne. Twyneo is the first such drug to combine the two components in the topical cream.
Sol-Gel said it expects to submit a marketing application to the U.S. Food and Drug Administration in the second half of 2020 and make Twyneo available to physicians and patients in the second half of 2021.
The company’s shares jumped to $29.99 before the opening bell.
Reporting by Trisha Roy and Shivani Singh in Bengaluru; Editing by Shinjini Ganguli and Maju Samuel