Soligenix Advances HyBryte Platform for Rare CTCL Therapy, Establishes Domestic Manufacturing

Soligenix Inc. is advancing its HyBryte platform to address the growing need for effective CTCL therapies. The company has established U.S.-based manufacturing for the active ingredient, positioning itself to meet the demands of the rare disease market, which affects over 30 million Americans. Soligenix's efforts align with the "Make America Healthy Again" initiative, aiming to enhance treatment accessibility and medical advances for the aging population.

Soligenix Inc. (NASDAQ: SNGX) is making significant strides in addressing the growing need for effective treatments in cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer primarily affecting older adults. The company has successfully established U.S.-based manufacturing for HyBryte™'s active ingredient, positioning itself to meet the demands of the rare disease market, which affects over 30 million Americans [1].

This development aligns with the "Make America Healthy Again" initiative, which aims to improve treatment accessibility and accelerate medical innovation, particularly for an aging population facing complex healthcare needs and often experiencing diagnostic delays [2]. The aging population's increasing life expectancy leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years [2].

Soligenix's HyBryte™ platform is a novel photodynamic therapy utilizing safe visible light for the treatment of CTCL. The company is currently in the final stages of clinical trials, having successfully completed the second Phase 3 study. With regulatory approvals sought to support potential commercialization worldwide, Soligenix is poised to make a meaningful impact on this underserved patient population [1].

In addition to its focus on CTCL, Soligenix is also developing other products to treat rare diseases where there is an unmet medical need. These include expansion of synthetic hypericin into psoriasis, the company’s first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, and SGX945 in Behçet’s disease [1].

Soligenix's efforts in the rare disease market are supported by government grants and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA) [1].

References:
[1] https://www.stocktitan.net/news/SNGX/soligenix-inc-nasdaq-sngx-proprietary-platform-aims-to-meet-growing-5jjsu5ov4cqg.html
[2] https://www.stocktitan.net/news/SNGX/soligenix-inc-nasdaq-sngx-innovative-platform-provides-novel-2qb6rra55x6n.html