Soligenix's SGX945 Shows Positive Phase 2a Results in Behçet's Disease Treatment.

Soligenix Inc. reported promising Phase 2a results for SGX945 in the treatment of Behçet's Disease, a rare inflammatory disorder. The trial showed a benefit in 7 of 8 patients, with many experiencing reduced symptoms after treatment. The company noted that the durability of the response may indicate a favorable chronic use profile for SGX945. Shares of Soligenix Inc. rose more than 20% in premarket hours.

Soligenix Inc. (NASDAQ: SNGX) has reported encouraging Phase 2a results for SGX945 in the treatment of Behçet's Disease, a rare inflammatory disorder. The trial demonstrated a benefit in 7 of 8 patients, with many experiencing reduced symptoms after treatment. The company noted that the durability of the response may indicate a favorable chronic use profile for SGX945. Shares of Soligenix Inc. rose more than 20% in premarket hours.

The study, which was open-label and conducted in Turkey, showed that SGX945, administered as a twice-weekly 4-minute intravenous infusion for 4 weeks, followed by a 4-week follow-up period, exhibited a 40% improvement in the area under the curve (AUC) of oral ulcers relative to historical placebo data. This is comparable to the 37% improvement seen with apremilast (Otezla), the current standard of care for Behçet's Disease [1].

SGX945's benefits persisted during the 4-week follow-up period even after treatment was discontinued, suggesting a durable biological effect. Seven out of eight patients reported perceived benefits from SGX945 treatment, including reduced duration and number of oral ulcers and decreased pain. One patient with a skin ulcer, typically difficult to treat, experienced resolution during the treatment period [2].

Unlike apremilast, which requires continuous administration and is associated with side effects including diarrhea (41%), nausea (19%), and headache (14%), SGX945 was well-tolerated with no treatment-related adverse events reported. This favorable tolerability profile, combined with twice-weekly dosing versus daily dosing for apremilast, could provide SGX945 a competitive advantage if approved [3].

Soligenix plans to reformulate SGX945 to enable home-based treatment via subcutaneous injection and will design a follow-on placebo-controlled Phase 2 study. This strategic decision aligns with current patient-friendly delivery trends and could expand SGX945's potential market beyond oral ulcers to include more difficult-to-treat manifestations like genital and skin ulcers, which apremilast is not approved to treat [1].

While the current study was small and open-label, the upcoming placebo-controlled Phase 2 study will be crucial to validate these promising initial results and clearly establish SGX945's efficacy profile in this challenging orphan disease with limited treatment options.

References:
[1] https://www.stocktitan.net/news/SNGX/biological-efficacy-demonstrated-in-a-phase-2-clinical-trial-of-ybrmt1wzku7h.html
[2] https://www.investing.com/news/company-news/soligenix-reports-positive-results-from-sgx945-behcets-trial-93CH-4162757
[3] https://www.nasdaq.com/articles/soligenix-reports-promising-phase-2a-results-sgx945-behcets-disease