Positive phase III results for two trials of Twyneo to treat acne. Sol Gel Technologies Ltd.

Sol-Gel Technologies, Ltd. announced top-line results from two pivotal Phase III 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. If approved, Twyneo has the potential to be the first acne vulgaris treatment to bring together benzoyl peroxide and a potent retinoid, tretinoin, in a once-daily cream � enabled using the Company�s proprietary microencapsulation technology.

Co-Primary Endpoint Results (Intention-to-Treat Population) : In trial SGT-65-04, 38.5% of patients treated with Twyneo achieved success in IGA versus 11.5% in the vehicle treated group (P<0.001). in trial sgt-65-05 25.4 of patients treated with twyneo achieved success in iga versus 14.7 in the vehicle group p="0.017)." in trial sgt-65-04 the absolute change from baseline of inflammatory lesion count for twyneo was -21.6 versus -14.8 for the vehicle group p><0.001). in trial sgt-65-05 the absolute change from baseline of inflammatory lesion count for twyneo was -16.2 versus -14.1 for the vehicle group p="0.021)." in trial sgt-65-04 the absolute change from baseline of non-inflammatory lesion count for twyneo was -29.7 versus -19.8 for the vehicle group p><0.001). in trial sgt-65-05 the absolute change from baseline of non-inflammatory lesion count for twyneo was -24.2 versus -17.4 for the vehicle group p><0.001).>

Safety and Tolerability : In both trials, Twyneo was found to be well-tolerated and the majority of local skin reactions, when reported, were mild and improved over time. There were no treatment-related serious adverse events and 4 unrelated serious adverse events (1 Twyneo, 3 vehicle) were reported across both trials.