Soligenix Launches Phase 2 Trial for SGX945 to Address Behçet's Disease

Soligenix Advances SGX945 Development for Behçet's Disease

Soligenix, Inc. (NASDAQ: SNGX), a biopharmaceutical firm committed to tackling rare diseases with significant unmet medical needs, has announced the initiation of a Phase 2 clinical trial for SGX945 (dusquetide). This trial, designated as Study DUS-AUBD-01, is now open for patient enrollment.

FDA Approval Marks a Milestone

With the receipt of approval from the FDA and the Turkish Medicines and Medical Devices Agency, Soligenix is specially positioned to kick off the trial. Christopher J. Schaber, PhD, the President and CEO of Soligenix, expressed enthusiasm, stating, "Our prior research has showcased the efficacy of dusquetide in treating conditions like oral mucositis, validating its potential in managing severe ulcers linked with Behçet's Disease. Our aim is to provide relief for patients enduring this complex, autoimmune disease, particularly those suffering from painful genital and leg ulcers."

Insights into the Clinical Trial

The upcoming trial aims to enroll around 25 adults suffering from mild to moderate Behçet's Disease coupled with active oral and/or genital ulcers. Participants will receive SGX945 through a twice-weekly intravenous (IV) infusion over four weeks, followed by four weeks of monitoring to assess the treatment's effectiveness.

Efficacy and Safety Endpoints

The clinical study will meticulously evaluate key efficacy endpoints, including the pace and extent of lesion clearance along with patient-reported quality of life metrics. These assessments are essential in measuring how SGX945 impacts individuals living with this debilitating condition.

Understanding Dusquetide's Mechanism

Dusquetide, the active ingredient in SGX945, is classified as an innate defense regulator (IDR), representing a novel class of synthetic peptides. Its unique mechanism focuses on modulating the body's responses to injury and infection, encouraging a healing process that is anti-inflammatory and promotes tissue recovery. This mechanism could be vital in treating the effects of Behçet's Disease, especially given the complexities associated with its symptoms.

Preclinical and Clinical Efficacy

Research has shown that dusquetide can enhance recovery from various health challenges, including tissue damage and infections. This healing potential was substantiated through various preclinical studies, with encouraging results observed in models of mucositis and colitis, highlighting the broader application of this innovative treatment.

Overview of Behçet's Disease

Behçet's Disease is characterized by inflammation of blood vessels, leading to symptoms like mouth sores, genital ulcers, and skin lesions. The fluctuating nature of this disease directly affects patients' quality of life. The estimated prevalence indicates around 18,000 affected individuals in the U.S. alone, with additional cases identified in Europe and globally.

Current Treatment Landscape

Treatment options for Behçet's Disease are primarily focused on symptom management. Corticosteroids and immune suppression therapies have been employed, but often come with a range of side effects and limited long-term efficacy. The only currently approved drug for maintaining oral ulcers in these patients is apremilast, which unfortunately presents additional challenges related to its cost and side effects.

About Soligenix

Soligenix is dedicated to advancing health solutions through specialized therapeutics aimed at rare diseases that lack adequate treatment options. In addition to SGX945, their Specialized BioTherapeutics segment is developing HyBryte™ for cutaneous T-cell lymphoma, showcasing the broader commitment to addressing pressing health issues faced by underserved populations.

Frequently Asked Questions

What is the focus of the SGX945 trial?

The trial is focused on evaluating the efficacy of SGX945 in treating Behçet's Disease, specifically targeting ulcers that severely impact patient quality of life.

How many patients will be enrolled in the SGX945 study?

The study aims to enroll approximately 25 patients aged 18 years or older with specific symptoms of Behçet's Disease.

What are the expected outcomes of the trial?

Key outcomes include the extent and timing of lesion clearance, along with improvements in quality of life as reported by participants.

What is the mechanism of action of dusquetide?

Dusquetide functions by regulating the innate immune response, promoting healing and reducing inflammation in tissues affected by various factors.

What other conditions is Soligenix researching?

In addition to Behçet's Disease, Soligenix is investigating treatments for conditions like oral mucositis and cutaneous T-cell lymphoma.

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