Soligenix Expands Advisory Board to Enhance Rare Disease Treatment Development for HyBryte™

Soligenix Strengthens Position in Rare Disease Treatments with Strategic Advisory Expansion

Soligenix, Inc., a late-stage biopharmaceutical company specializing in treatments for rare diseases, is making significant strides in its operations as it prepares for a critical Phase 3 clinical study of its drug candidate, HyBryte™. The company has announced the expansion of its European Medical Advisory Board (MAB) to include prominent dermatologists, Drs. Scarisbrick and Vermeer. This strategic enhancement aims to provide expert guidance as Soligenix seeks marketing approvals in Europe for HyBryte™, which is designed to treat early-stage cutaneous T-cell lymphoma (CTCL). The expanded MAB now consists of five recognized leaders in dermatology, who will play a pivotal role in advising on clinical strategies, health economics, and reimbursement issues as the company navigates the complexities of regulatory approval.

The upcoming Phase 3 clinical trial, a multicenter, double-blind, placebo-controlled study, is set to enroll approximately 80 patients and will last 18 weeks. Soligenix anticipates reporting top-line results in the latter half of 2026, making the MAB's expertise particularly timely. Christopher J. Schaber, PhD, President and CEO of Soligenix, emphasizes the importance of this advisory board in shaping the development and approval processes for HyBryte™ within the European Union (EU) and the United Kingdom (UK). With the MAB's guidance, Soligenix aims to ensure that its clinical trial aligns closely with patient needs, ultimately driving towards successful commercialization.

This expansion of the MAB represents a concerted effort by Soligenix to bolster its strategic planning as it approaches key milestones in its research and development pipeline. The insights provided by the board members are expected to enhance the overall efficacy of the trial and address any potential hurdles related to market entry. By leveraging the expertise of esteemed dermatologists, Soligenix positions itself to effectively engage with regulatory bodies and maximize the potential impact of HyBryte™ for patients suffering from CTCL.

In addition to its advisory board expansion, Soligenix has recently closed a public offering that raised approximately $7.5 million, reinforcing its financial stability as it ventures forward. The funds will be allocated towards research and development, commercialization efforts, and general corporate purposes. This funding, coupled with the advisory board's strategic insights, positions Soligenix well as it aims to meet the unmet medical needs in the realm of rare diseases.

As Soligenix moves ahead with its plans, the collaboration with its expanded MAB and the recent funding boost highlight the company's commitment to advancing innovative therapies while ensuring a solid foundation for its future endeavors.