Soligenix

Soligenix forms European Medical Advisory Board for HyBryte™ Phase 3 CTCL study, targeting 2024 initiation with 80 patients in US and Europe, aiming for 2026 results.

Soligenix opens patient enrollment for Phase 2 study DUS-AUBD-01 evaluating SGX945 (dusquetide) for Behçet's Disease, aiming to address significant unmet medical needs.

Soligenix opens patient enrollment for Phase 2 study DUS-AUBD-01, evaluating SGX945 (dusquetide) for Behçet's Disease treatment.

Soligenix initiates Phase 2 trial of SGX945 (dusquetide) for Behçet's Disease treatment, aiming to address unmet medical needs with a focus on severe ulcers. The open-label study will enroll 25 patients with mild to moderate Behçet's Disease, evaluating SGX945's efficacy in lesion clearance and quality of life. Dusquetide, an innate defense regulator, has shown promise in previous studies for oral mucositis and may offer significant relief for Behçet's Disease patients.

Soligenix (NASDAQ:SNGX) plans to start a Phase 3 trial of HyBryte for CTCL by end of 2024, with expected results in H2 2026. Recent supportive trials showed HyBryte's efficacy and safety. A partnership with Sterling Pharma aims to scale hypericin production. Q3 2024 financials showed no revenue, with R&D expenses up due to new trials. Soligenix holds $9.8M in cash and expects data from ongoing trials in 2025.

The T-cell malignancies market is expanding due to increased incidence, treatment advancements, and strategic partnerships. Key companies like Corvus Pharmaceuticals, Bristol-Myers Squibb, and Kymera Therapeutics are developing over 80 pipeline therapies. Notable drugs include Soquelitinib (Phase III), MB 105 (Phase II), and KT-333 (Phase I). Regulatory milestones and positive trial results are driving progress in this field.

Soligenix presents HyBryte™ therapy findings at EORTC meeting, showing improved response rates with extended treatment and increased light doses in cutaneous T-cell lymphoma (CTCL).

Soligenix partners with Sterling Pharma Solutions to optimize synthetic hypericin production for HyBryte™ and SGX302, targeting CTCL and psoriasis. The collaboration aims to scale up manufacturing for clinical trials and commercialization, with a focus on reducing costs and advancing clinical programs.