Sol-Gel Announces Top-Line Phase 3 Trial Results Of Twyneo For The Treatment Of Acne Vulgaris; Twyneo Was Well Tolerated And All Co-Primary Endpoints In Both Phase 3 Trials Were Achieved

All co-primary endpoints achieved in both Phase 3 clinical trials Twyneo was well-tolerated and the majority of local skin reactions, when reported, were mild and improved over time Additional data to be shared

Benzinga · 12/30/2019 12:06
  • All co-primary endpoints achieved in both Phase 3 clinical trials
  • Twyneo was well-tolerated and the majority of local skin reactions, when reported, were mild and improved over time
  • Additional data to be shared during the January 8th investor conference call and webcast

NESS ZIONA, Israel, Dec. 30, 2019 (GLOBE NEWSWIRE) --  Sol-Gel Technologies, Ltd. (NASDAQ:SLGL) today announced top-line results from two pivotal Phase 3 clinical trials for Twyneo®, an investigational, combination of microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream, which demonstrated statistically significant improvement on all co-primary endpoints in the treatment of patients with acne vulgaris. Twyneo was also found to be well-tolerated.

The primary endpoints for both trials included: the proportion of patients who succeeded in achieving at least a two grade reduction from baseline and Clear (grade 0) or Almost Clear (grade 1) at Week 12 on a 5-point Investigator Global Assessment (IGA) scale; an absolute change from baseline in inflammatory lesion count at Week 12; and an absolute change from baseline in non-inflammatory lesion count at Week 12.