Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels

On Thursday, Soligenix Inc. SNGX opened patient enrollment for its DUS-AUBD-01 Phase 2 study evaluating SGX945 (dusquetide) for Behçet's Disease, an inflammatory disorder of the blood vessels (vasculitis).

The company looks forward to completing enrollment and announcing study results in the first half of 2025.

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 and active oral and/or genital ulcers.

Patients will receive SGX945 as a twice-weekly 4-minute intravenous (IV) infusion for 4 weeks, followed by 4 weeks of follow-up.

Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient reported quality of life assessments.  

Dusquetide, the active ingredient in SGX945 (Behçet's Disease) and SGX942 (oral mucositis), is an innate defense regulator (IDR), a new class of short, synthetic peptides.

Dusquetide has demonstrated safety and tolerability in a Phase 1 study in 84 healthy human volunteers.

In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits.

There are approximately 18,000 known cases of Behçet's Disease in the U.S., 350,000 in Turkey, and over 50,000 in Europe. There are as many as 1 million people worldwide living with Behçet's Disease.

In July, The Princeton, New Jersey-based company announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended Hybryte treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL).

Patients have responded positively to HyBryte therapy. Three of the four subjects who have completed at least 12 weeks of therapy already achieved "Treatment Success."

Price Action: At the last check on Thursday, SNGX stock traded higher by 1.10% to $3.67 premarket.

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