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.
相关临床试验
14
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1987
进行中（未招募）
2
14.3%
已完成
8
57.1%
招募中
1
7.1%
终止
3
21.4%
暂无批准数据
- Soligenix's optimized gel formulation of SGX302 (synthetic hypericin) demonstrated clinical success in Cohort 3 of its Phase 2a psoriasis trial, with one patient achieving "Almost Clear" status and over 50% PASI score improvement. - The photodynamic therapy uses safe visible light activation and was well tolerated with no drug-related adverse events, potentially offering a non-carcinogenic alternative to current UV-based treatments. - The global psoriasis treatment market is valued at approximately $15 billion in 2020 and projected to reach $40 billion by 2027, with 60-125 million people worldwide living with the condition. - Soligenix plans to continue pursuing SGX302 development in psoriasis while advancing its confirmatory Phase 3 trial for HyBryte™ in cutaneous T-cell lymphoma, with topline results expected in the second half of 2026.
- Aethlon Medical's Hemopurifier showed encouraging changes in extracellular vesicles, microRNAs, and lymphocytes in cancer patients not responding to anti-PD-1 therapy. - Envoy Medical received FDA approval to expand its pivotal trial for the fully implanted Acclaim cochlear implant, shortening commercialization timeline by 3-6 months. - Soligenix's Data Monitoring Committee confirmed no safety concerns for HyBryte in treating cutaneous T-cell lymphoma, with topline results expected in H2 2026. - MBX Biosciences achieved statistical significance in its Phase 2 trial of canvuparatide for chronic hypoparathyroidism, with 63% of patients meeting the primary endpoint.
- Soligenix priced a public offering of 5.56 million shares and warrants at $1.35 per unit, raising approximately $7.5 million in gross proceeds. - The late-stage biopharmaceutical company will use funds for research and development activities, commercialization efforts, and general corporate purposes. - The company's pipeline includes HyBryte for cutaneous T-cell lymphoma treatment and vaccine candidates for biodefense applications. - Existing warrants from previous offerings will be amended to reduce exercise price to $1.35 per share to align with the new offering terms.
- Soligenix's SGX945 demonstrated biological efficacy in a Phase 2a trial for Behçet's disease, achieving a 40% improvement in oral ulcer outcomes compared to 37% for FDA-approved apremilast. - The treatment showed sustained benefits through an 8-week follow-up period despite stopping therapy at week 4, with 7 of 8 patients reporting perceived clinical benefit. - SGX945 was well-tolerated with no treatment-related adverse events, contrasting with apremilast's common side effects including diarrhea, nausea, and headache. - The company plans to reformulate SGX945 for home-based subcutaneous administration and advance to a placebo-controlled Phase 2 study targeting this rare inflammatory disease affecting up to 1 million people worldwide.
- Soligenix successfully transferred manufacturing of synthetic hypericin from Europe to the U.S. through partnership with Sterling Pharma Solutions, establishing scalable cGMP production for clinical trials. - The synthetic hypericin serves as the active ingredient in HyBryte™ and SGX302, topical photodynamic therapies being developed for cutaneous T-cell lymphoma and psoriasis treatment. - HyBryte™ demonstrated significant efficacy in Phase 3 trials with 16% of patients achieving 50% lesion reduction versus 4% with placebo, leading to FDA orphan drug and fast track designations. - A second confirmatory Phase 3 trial (FLASH2) is planned to enroll approximately 80 patients with early-stage CTCL, following EMA agreement on key design components.
- Soligenix is developing SGX943 (dusquetide), a novel broad-spectrum therapy designed to treat bacterial infections without relying on conventional antibiotics. - The treatment addresses the urgent medical need for alternatives to traditional antibiotics amid rising antibiotic resistance threats to public health. - Preclinical studies have demonstrated the efficacy of SGX943 in various models of bacterial infection, positioning it as a potential breakthrough therapy. - The development comes as the overuse and misuse of antibiotics have led to the emergence of antibiotic-resistant bacteria, creating significant public health challenges.
- 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 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 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 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.
