Soligenix Drug Matches FDA-Approved Amgen Therapy In Rare Disease Trial

 Soligenix Inc. (NASDAQ:SNGX) shares surged on Thursday as the company announced positive results from its Phase 2a proof-of-concept study of SGX945 (dusquetide) in Behçet’s disease, a rare and chronic inflammatory condition.

The company reported that SGX945 achieved the trial’s primary goal of demonstrating biological efficacy in treating oral ulcers, a hallmark symptom of Behçet’s disease.

This disorder, while rare, presents serious quality-of-life challenges for patients due to recurrent mouth and genital sores, eye inflammation, and painful skin lesions.

The Phase 2a study was an open-label study designed to be highly comparable to the published Phase 3 study of Amgen Inc.’s (NASDAQ:AMGN) apremilast (Otezla) used to support marketing approval for oral ulcers in Behçet’s disease. SGX945 outcomes were compared to the apremilast and placebo arms in this Phase 3 study.

Over 4 weeks of treatment, the area under the curve (AUC; a composite measurement of both peak number of oral ulcers and the time to resolution of the oral ulcers), average number of oral ulcers, and improvements in oral pain for SGX945 were similar to outcomes obtained in the apremilast study.

Outcomes in weeks 5 through 8 continued to show similar outcomes to the apremilast study, even though apremilast treatment was continued through this period whereas SGX945 treatment was stopped at Week 4, per study design. The primary endpoint in the Phase 3 apremilast study was the AUC of the mean number of ulcers versus time.

Using this same endpoint after 4 weeks of treatment, the SGX945-treated group had a 40% improvement relative to the placebo group from the Phase 3 apremilast study, whereas apremilast had a 37% improvement relative to the placebo.

This improvement was sustained throughout the 4-week follow-up after treatment with SGX945, with 32% improvement evaluated at Week 8 despite treatment having stopped at Week 4.

In contrast, apremilast, which was continuously administered through Week 12, had a 41% improvement at Week 8. The improvements in oral pain mimicked the results in the AUC measurement.

Seven of 8 patients reported perceived benefit with SGX945 treatment, with common outcomes including reduced duration of oral ulcers, reduced number of oral ulcers, and reduced oral pain. One patient began the study with a punctuated skin ulcer, which also resolved during the 4-week treatment with SGX945.

https://finance.yahoo.com/news/soligenix-drug-matches-fda-approved-130010990.html