Why Is This Rare Disease-Focused Soligenix Stock Trading Over 200% Today?

The FDA has cleared Soligenix Inc's SNGX Investigational New Drug (IND) application for a Phase 2a clinical trial for SGX945 (dusquetide) for aphthous ulcers in Behçet's disease. 

Behçet disease is a rare vasculitic disorder that can affect small, medium, and large vessels and is characterized by a triple-symptom complex of recurrent oral aphthous ulcers, genital ulcers, and uveitis.

The study is designed to evaluate the safety and efficacy of SGX945 and is expected to begin patient enrollment in the second half of 2024.

Behçet's disease is an unmet medical need, with up to 18,000 people in the U.S., 80,000 in Europe, 350,000 people in Turkey, and as many as 1 million people worldwide affected by this disease. 

Under this IND, the pilot clinical trial of SGX945 will be an open-label study that will enroll approximately 25 patients aged 18 years or older with mild to moderate Behçet's disease active oral and/or genital ulcers. 

Patients will receive SGX945 as a twice weekly 4-minute intravenous (IV) infusion for four weeks. Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient-reported quality of life indices.

Price Action: SNGX shares are up 171.9% at $1.13 on the last check Thursday.