Soligenix
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1987-01-01
- Employees
- 15
- Market Cap
- $8.8M
- Website
- http://www.soligenix.com
- Introduction
Soligenix, Inc. is a late-stage biopharmaceutical company, which engages in the development and commercialization of products to treat rare diseases. It operates through the Specialized BioTherapeutics and Public Health Solutions segments. The Specialized BioTherapeutics segment focuses on the development of a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma. The Public Health Solutions segment consists of active development programs for RiVax, a ricin toxin vaccine candidate, and SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease. The company was founded in 1987 and is headquartered Princeton, NJ.
Latest Updates on FDA Approvals and Processes
The Food and Drug Administration (FDA) continues to oversee the approval process for new products, drugs, therapies, and treatments, with updates on applications, safety alerts, and more.
HyBryte Shows Sustained Improvement in CTCL Lesions Post-Treatment
• Soligenix's HyBryte demonstrated continued improvement in cutaneous T-cell lymphoma (CTCL) lesions even after treatment cessation.
• A comparative study showed a statistically significant improvement in plaque lesion response with HyBryte versus Valchlor at week 16 (p=0.006).
• HyBryte was well-tolerated, with no related adverse events, contrasting with Valchlor, which had a 60% related adverse event rate.
• Soligenix plans to initiate a confirmatory Phase 3 trial (FLASH2) to further evaluate HyBryte's efficacy and safety in CTCL patients.
Soligenix's HyBryte Enrolls First Patients in Phase 3 CTCL Trial
• Soligenix initiates patient enrollment for the confirmatory Phase 3 FLASH2 trial of HyBryte for cutaneous T-cell lymphoma (CTCL).
• The FLASH2 trial builds upon previous positive Phase 3 results, aiming to demonstrate HyBryte's efficacy with an extended 18-week treatment period.
• HyBryte, a novel photodynamic therapy, has shown a promising safety profile and efficacy in early-stage CTCL, offering a new treatment option.
• Interim analysis of the FLASH2 study is anticipated in early 2026, with periodic updates on the trial's progress expected in 2025.
Soligenix Forms European Medical Advisory Board for HyBryte CTCL Trial
• Soligenix has established a European Medical Advisory Board (MAB) to guide its Phase 3 trial of HyBryte™ for cutaneous T-cell lymphoma (CTCL).
• The Phase 3 study will enroll approximately 80 patients in the U.S. and Europe, with topline results expected in the second half of 2026.
• The MAB comprises European physicians experienced in CTCL treatment and clinical research, offering expertise in clinical strategies and regulatory interactions.
• HyBryte™ (synthetic hypericin) is a photodynamic therapy being evaluated for early-stage CTCL, with potential for improved safety over existing treatments.
Soligenix Establishes European Medical Advisory Board for HyBryteâ„¢ CTCL Phase 3 Trial
• Soligenix has formed a European Medical Advisory Board (MAB) to guide the Phase 3 trial of HyBryte™ for cutaneous T-cell lymphoma (CTCL).
• The Phase 3 study will evaluate HyBryte™ in approximately 80 patients across the U.S. and Europe, with topline results expected in 2026.
• The European MAB comprises renowned physicians experienced in CTCL treatment and clinical research, providing strategic input on clinical and regulatory aspects.
• HyBryte™ is a novel photodynamic therapy that has shown statistically significant improvements in CTCL lesions in prior clinical studies.
Soligenix Launches Phase 2 Trial of SGX945 (Dusquetide) for Behçet's Disease
• Soligenix has initiated a Phase 2 clinical trial to evaluate SGX945 (dusquetide) for treating aphthous ulcers associated with Behçet's Disease, a chronic auto-immune condition.
• The open-label study will enroll approximately 25 patients, administering SGX945 intravenously twice weekly for four weeks, followed by a four-week follow-up period.
• The trial's primary endpoints include assessing lesion clearance, time to lesion clearance, and patient-reported quality of life improvements, with results expected in H1 2025.
• Dusquetide, an innate defense regulator (IDR), modulates the body's immune response to promote anti-inflammatory, anti-infective, and tissue-healing effects.
Soligenix Launches Phase 2 Trial of SGX945 (Dusquetide) for Behçet's Disease
• Soligenix has initiated a Phase 2 clinical trial to evaluate SGX945 (dusquetide) for treating aphthous ulcers associated with Behçet's Disease.
• The open-label study will enroll approximately 25 patients with mild to moderate Behçet's Disease, assessing lesion clearance and quality of life.
• SGX945, an innate defense regulator, aims to modulate the body's inflammatory response and promote tissue healing in this chronic auto-immune disease.
• Topline results from the trial are expected in the first half of 2025, offering hope for an underserved patient population with limited treatment options.
Soligenix Initiates Phase 2 Trial of SGX945 (Dusquetide) for Behçet's Disease
• Soligenix has commenced patient enrollment in a Phase 2 clinical trial to evaluate SGX945 (dusquetide) for the treatment of Behçet's Disease.
• The open-label study will enroll approximately 25 patients with mild to moderate Behçet's Disease and active oral and/or genital ulcers.
• SGX945 will be administered as a twice-weekly intravenous infusion for four weeks, followed by a four-week follow-up period to assess lesion clearance and quality of life.
• Top-line results from the Phase 2 trial are expected in the first half of 2025, offering hope for an underserved patient population.
Soligenix Initiates Phase 2 Trial of Dusquetide (SGX945) for Behçet's Disease
• Soligenix has commenced patient enrollment in a Phase 2 clinical trial evaluating SGX945 (dusquetide) for the treatment of Behçet's Disease.
• The open-label study will enroll approximately 25 patients with mild to moderate Behçet's Disease, assessing lesion clearance and quality of life.
• Dusquetide, an innate defense regulator, aims to modulate the body's inflammatory response and promote tissue healing in Behçet's Disease ulcers.
• Topline results from the Phase 2 trial are expected in the first half of 2025, offering hope for an underserved patient population.
Soligenix to Initiate Phase 3 Trial of HyBryte for Cutaneous T Cell Lymphoma
• Soligenix is set to begin a Phase 3 trial (FLASH2) of HyBryte for cutaneous T cell lymphoma (CTCL) treatment before the end of 2024, mirroring the design of the previous FLASH trial.
• Recent data presented at EORTC highlighted HyBryte's effectiveness and favorable safety profile compared to Valchlor in treating CTCL, alongside minimal systemic exposure.
• Soligenix has partnered with Sterling Pharma Solutions to enhance the manufacturing process for synthetic hypericin, aiming to reduce production costs for HyBryte.
• Anticipated topline results from the FLASH2 trial are expected in the second half of 2026, marking a significant milestone in HyBryte's development for CTCL.
Dermatology Advances: Approvals, Trial Results, and New Guidelines Emerge
• The FDA approved bimekizumab for moderate-to-severe hidradenitis suppurativa, marking the first treatment targeting both IL-17A and IL-17F cytokines.
• Subcutaneous nivolumab's PDUFA date was updated, based on Phase 3 data demonstrating noninferiority to intravenous nivolumab in renal cell carcinoma.
• New clinical guidelines emphasize image-guided superficial radiation therapy for nonmelanoma skin cancers, improving precision in treating basal and squamous cell carcinoma.
• Phase 2b trial results show mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival in high-risk stage III/IV melanoma patients.
T-Cell Malignancy Pipeline Shows Promise with Novel Therapies and Approvals
• The T-cell malignancies market is experiencing growth driven by increased incidence, treatment advancements, and strategic biopharma partnerships.
• Several companies, including Corvus Pharmaceuticals and Kymera Therapeutics, are advancing novel therapies through clinical trials, targeting unmet needs in T-cell lymphomas.
• Regulatory milestones, such as FDA Fast Track Designation for soquelitinib and EMA Orphan Drug Designation for SLS009, are accelerating the development of new treatments.
• Research and development efforts, highlighted by presentations at major conferences like EHA, are yielding promising clinical data for drugs like KT-333.
HyBryteâ„¢ Shows Improved Response Rates in Cutaneous T-Cell Lymphoma with Extended Treatment
• Soligenix's HyBryte™ (synthetic hypericin) demonstrates improved response rates in cutaneous T-cell lymphoma (CTCL) with extended treatment and increased light doses.
• Presentations at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting highlight the utility of longer treatment times with HyBryte™.
• Studies show HyBryte™ has minimal systemic exposure and is relatively efficacious and tolerable compared to Valchlor® in CTCL treatment.
• A second Phase 3 trial, FLASH2, is expected to begin before the end of 2024, building on positive results from the initial FLASH study.
HyBryte Shows Promising Results in Early-Stage Cutaneous T-Cell Lymphoma Treatment
Extended treatment with SGX301 (HyBryte) has shown significant lesion responses in patients with early-stage cutaneous T-cell lymphoma (CTCL), according to updated data from an interim analysis of the phase 2 RW-HPN-MF-01 trial. The treatment has been safe and well-tolerated, with no documented treatment-related adverse effects. The study aims to evaluate the efficacy of HyBryte in a real-world treatment setting, supporting previous positive phase 2 and 3 clinical trial results.
HyBryteâ„¢: A Promising Photodynamic Therapy for Cutaneous T-Cell Lymphoma (CTCL)
HyBryteâ„¢, a photodynamic therapy using synthetic hypericin and visible fluorescent light, shows promise as a safe and effective treatment for Cutaneous T-Cell Lymphoma (CTCL), particularly in early-stage disease. With no FDA-approved first-line therapy for CTCL, HyBryteâ„¢ aims to reduce disease progression and toxic side effects, offering a new hope for approximately 20,000 patients in the US affected by this chronic condition.
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