Soligenix's SGX945 Demonstrates Biological Efficacy in Behçet's Disease Phase 2 Trial.

Biological efficacy demonstrated in Phase 2 trial of SGX945 for Behçet's Disease treatment. Study results support advancing SGX945 in this difficult-to-treat orphan disease. Soligenix, a biopharmaceutical company, completed the Phase 2a proof-of-concept study, achieving the objective of demonstrating biological efficacy. The study was an open-label trial designed to be highly comparable to the published Phase 3 study of apremilast.

Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases, has announced the successful completion of its Phase 2a proof-of-concept study for SGX945 (dusquetide) in the treatment of Behçet's Disease. The study demonstrated biological efficacy, supporting the advancement of SGX945 in this challenging-to-treat orphan disease.

The Phase 2a trial, conducted as an open-label study, enrolled eight patients aged 18 years or older with mild to moderate Behçet's Disease and active oral and/or genital ulcers. The study participants received SGX945 as a twice-weekly 4-minute intravenous (IV) infusion for four weeks, followed by a four-week follow-up period. The primary objective was to demonstrate biological efficacy, and the results showed that SGX945 achieved this goal.

The study's outcomes were compared to both the apremilast and placebo arms in a published Phase 3 study. Over four weeks of treatment, the area under the curve (AUC), average number of oral ulcers, and improvements in oral pain for SGX945 were similar to those observed in the apremilast study. Notably, improvements in oral pain were sustained throughout the 4-week follow-up period, despite treatment with SGX945 being stopped at week 4. Seven of the eight patients reported perceived benefit from SGX945 treatment, with common outcomes including reduced duration and number of oral ulcers, and reduced oral pain.

SGX945 was well-tolerated, with no treatment-related adverse events observed. In contrast, common adverse events for apremilast included diarrhea, nausea, and headache. The study's lead investigator, Dr. Gülen Hatemi, MD, noted the potential for SGX945 to offer significant relief to patients with Behçet's Disease, particularly for more severe ulcers such as genital and skin ulcers. Soligenix plans to reformulate SGX945 for home-based treatment using subcutaneous injection, as seen with weight-loss drugs.

Behçet's Disease is an inflammatory disorder of the blood vessels, affecting approximately 18,000 people in the U.S., 50,000 in Europe, and up to 1 million worldwide. The disease is characterized by mouth sores, skin rashes and lesions, genital sores, leg ulcers, and eye inflammation. Currently, the only approved drug for Behçet's Disease is apremilast, which must be taken continuously and has limited market penetration due to its cost and side effects.

Soligenix intends to embark on a reformulation of SGX945 to enable home-based treatment and plans to interact with health authorities to design a follow-on placebo-controlled Phase 2 study. The company's long-term strategy includes expanding the development of dusquetide into different innate immune-related inflammatory conditions.

References:
[1] https://finance.yahoo.com/news/biological-efficacy-demonstrated-phase-2-113000829.html