Soligenix Completes Phase 2a Study for SGX945, Demonstrates Biological Efficacy in Treating Behçet’s Disease

Soligenix has completed its Phase 2a study for SGX945, demonstrating biological efficacy in treating Behçet's Disease. The study showed a 40% improvement in oral ulcers compared to placebo and was well-tolerated without adverse effects. This development positions Soligenix to explore SGX945's potential in treating other inflammatory conditions and expand its market presence.

Title: Soligenix Completes Phase 2a Study, Demonstrates Biological Efficacy of SGX945 in Treating Behçet's Disease

Soligenix, Inc. (Nasdaq: SNGX) has successfully completed its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behcet's Disease. The study achieved its primary objective of demonstrating biological efficacy, showing a 40% improvement in oral ulcers compared to placebo. The results indicate that SGX945 was well-tolerated, with no treatment-related adverse events observed.

The Phase 2a study was an open-label, highly comparable design to the published Phase 3 study of apremilast (Otezla) used to support marketing approval for oral ulcers in Behcet's disease. Over four weeks of treatment, SGX945 outcomes were similar to those obtained in the apremilast study, including improvements in the area under the curve (AUC) of oral ulcers and oral pain. Notably, the improvements were sustained throughout the 4-week follow-up period, despite treatment with SGX945 being stopped at week 4. Seven out of eight patients reported perceived benefit with SGX945 treatment, with common outcomes including reduced duration, number, and pain of oral ulcers.

SGX945 was well-tolerated with no adverse events, unlike apremilast, which has common side effects such as diarrhea, nausea, and headache. The study's lead investigator, Dr. Gulen Hatemi, stated that the results with SGX945 were historically comparable to those observed in the apremilast study. Soligenix plans to reformulate SGX945 for home-based treatment and expand its development into other innate immune-related inflammatory conditions.

The completion of this study positions Soligenix to explore the potential of SGX945 in treating other inflammatory conditions, potentially expanding its market presence. Behcet's Disease, an inflammatory disorder of the blood vessels, affects approximately 18,000 people in the U.S., 50,000 in Europe, and 350,000 in Turkey. With no cure available, treatments are focused on managing symptoms, with apremilast being the only approved drug for oral ulcers. The continuous use of apremilast is associated with high cost and side effects, making SGX945 a promising alternative.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical needs. The company's Specialized BioTherapeutics business segment is also developing HyBryte (SGX301) for cutaneous T-cell lymphoma (CTCL).

References:
[1] https://www.marketscreener.com/news/soligenix-inc-biological-efficacy-demonstrated-in-a-phase-2-clinical-trial-of-sgx945-for-the-tre-ce7c5fd3d988f022