Positive top-line data from two pivotal phase III studies of acne vulgaris treatment Twyneo from Sol-Gel Technologies Ltd. is doing the stock end-of the-year favors as shares closed up 17.5% at $17.15 on Tuesday.
Sol-Gel, of Ness Ziona, Israel, plans to submit its NDA in the second half of 2020, with hopes of approval in the second half of 2021, according to Alon Seri-Levy, Sol-Gel’s co-founder and CEO.
Twyneo, comprising microencapsulated tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream, showed statistically significant improvement on all co-primary endpoints and was well-tolerated. Primary endpoints for each trial included the proportion of patients succeeding in achieving at least a two-grade reduction from baseline and “clear” (grade 0) or “almost clear: (grade 1) at week 12 on a five-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.
In the trial of SGT-65-04, 38.5% of patients treated with Twyneo achieved success in IGA vs. 11.5% in the vehicle-treated group (p<0.001). The absolute change from baseline of inflammatory lesion count for Twyneo was -21.6 vs. -14.8 for the vehicle group (p<0.001). The absolute change from baseline of non-inflammatory lesion count for Twyneo was -29.7 vs. -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 vs. -17.4 for the vehicle group (p<0.001), while 25.4% of patients treated with Twyneo achieved success in IGA vs. 14.7% in the vehicle group (p=0.017). The absolute change from baseline of inflammatory lesion count for Twyneo was -16.2 vs. -14.1 for the vehicle group (p=0.021).
In the past year, Sol-Gel shares (NASDAQ: SLGL) bounced around from about $6 to $10 each but this week’s surge puts them into the $17-plus range.
Both studies found Twyneo to be well-tolerated. The majority of local skin reactions, when reported, were mild and improved over time. There were no treatment-related serious adverse events. Four unrelated serious adverse events (one Twyneo, three vehicle) were reported across both studies.
Others making acne their business include Galderma SA, of Lausanne, Switzerland, with its retinoid molecule Aklief (trifarotene 50 mcg/g cream) for treating the face and/or the trunk in patients 12 and older, which was approved by the FDA in October. Aklief is a topical cream targeting retinoic acid receptor gamma.
In October, the FDA approved Amzeeq (minocycline topical foam 4%) from Foamix Pharmaceuticals Ltd., of Rehovot, Israel, for treating inflammatory lesions of non-nodular moderate to severe acne vulgaris in adult and pediatric patients age 9 and older. In November, Foamix completed enrollment for its phase II clinical trial of FCD-105, a 3% minocycline, 0.3% adapalene combination foam for moderate to severe acne vulgaris.
In December, Biomx Inc., of Ness Ziona, Israel, completed enrollment of 75 patients in a phase I study designed to measure the safety and tolerability of BX-001, a naturally occurring phage targeting Cutibacterium acnes. Data are expected in the first quarter of 2020.