Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases and areas of unmet medical need, has a portfolio of products aimed at treating orphan diseases. The United States (U.S.) Food and Drug Administration (FDA) defines an orphan disease as a rare disease or condition that affects fewer than 200,000 people in the U.S.. By focusing primarily on rare diseases, Soligenix can address the needs of niche but critical markets while having a long-lasting impact on patients’ outcomes and quality of life.
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00:00With rare diseases on the rise, the demand for next-generation pharmaceutical solutions has never been greater.
00:07Soligenics, a late-stage biopharmaceutical company, is making significant strides with an innovative dual focus on specialized biotherapeutics and public health solutions.
00:16This dual strategy spans treatments for orphan conditions, such as cutaneous T-cell lymphoma, psoriasis, oral mucositis, and Bessett's disease,
00:26as well as medical countermeasures against emerging threats like ricin toxin, pseudantipolavirus, and other viruses.
00:33Among Soligenics' diverse pipeline, Hybrite is at the forefront for the treatment of CTCL, a chronic skin cancer.
00:40It's a cutting-edge photodynamic therapy, harnessing synthetic hypericin, which is applied topically to the cancerous lesions and then activated by safe, visible light.
00:49The result? Oxygen radicals form, selectively destroying malignant T-cells.
00:54Having demonstrated statistically significant and rapid efficacy across Phase I, II, and III clinical trials,
01:00Hybrite is now actively enrolling in a second conformatory Phase III trial in 80 CTCL patients.
01:06Top-line results are anticipated in 2026.
01:09According to Soligenics' Chief Medical Officer, Dr. Richard Straub,
01:13this approach features a very benign safety profile, setting a new benchmark for CTCL therapies.
01:19In addition to Hybrite, Soligenics is advancing SGX-302, also leveraging synthetic hypericin, for psoriasis,
01:26as well as SGX-945 for Bessett's disease, among other drug candidates.
01:31Meanwhile, government-backed funding north of $60 million to date supports the company's Bryvax, a ricin toxin vaccine,
01:38and Suvax, a Sudan Ebola virus vaccine.
01:42From a market standpoint, CTCL alone is expected to expand to over $4.5 billion by 2030,
01:49and psoriasis can reach a global value of $40 billion by 2027.
01:54By targeting these potentially lucrative niches and having options for large-scale public health needs,
01:59Soligenics positions itself for broad impact in both patient outcomes and commercial success.
02:05As the company forges ahead, its dual-focused approach could help redefine how rare diseases
02:11and emerging global threats are treated in the years to come.