A West Windsor biotech firm says it is entering a pivotal year as new clinical data and regulatory milestones build momentum for two of its key drug candidates.
Soligenix Inc., headquartered on Emmons Drive, has reported a series of recent developments across its rare disease pipeline, including newly published results for its HyBryte treatment candidate in cutaneous T-cell lymphoma, a European orphan drug designation for SGX945 in Behçet’s disease, and additional findings presented at a national workshop.
The late-stage biopharmaceutical company said April 2 that results from a comparative study evaluating HyBryte, also known as synthetic hypericin, against Valchlor, or mechlorethamine, for cutaneous T-cell lymphoma were published in the journal “Oncology and Therapy.”
According to the company, the study found that HyBryte demonstrated a more rapid and robust treatment response than Valchlor during a 12-week treatment period. Soligenix said the findings add to the clinical evidence supporting HyBryte as a non-invasive, skin-directed treatment option for patients with early-stage disease.
Cutaneous T-cell lymphoma is a rare form of non-Hodgkin lymphoma that primarily affects the skin. Patients can experience persistent rashes, lesions, scaling, discoloration and itching, and the condition often must be managed over a long period of time rather than cured quickly. Existing treatment options can include topical therapies, light-based therapies and other medications, but effectiveness and tolerability can vary from patient to patient.
HyBryte is designed as a light-activated therapy. In simple terms, the drug is applied to the skin and then exposed to a specific wavelength of visible light, which activates the compound and is intended to destroy cancerous cells while limiting damage to surrounding healthy tissue. The company has said that approach could offer a more targeted alternative to traditional skin-directed chemotherapy treatments.
The April 2 announcement followed a March 20 company release stating that findings from supportive HyBryte trials were scheduled to be presented March 26 at the United States Cutaneous Lymphoma Consortium Workshop, held ahead of the American Academy of Dermatology Annual Meeting.
Soligenix said the presentation was delivered by Dr. Ellen Kim, director of the Penn Cutaneous Lymphoma Program, vice chair of clinical operations in the dermatology department, and a professor of dermatology at the Hospital of the University of Pennsylvania.
The company identified Kim as the principal investigator for both the first Phase 3 FLASH study and the ongoing Phase 3 FLASH2 study. FLASH stands for Fluorescent Light Activated Synthetic Hypericin.
According to Soligenix, the workshop presentation detailed positive results from a recently completed investigator-initiated study involving HyBryte in patients with cutaneous T-cell lymphoma. The company said those findings further supported the treatment’s potential as it continues development of FLASH2, its confirmatory late-stage study.
In a separate March 26 announcement, Soligenix said the European Commission granted orphan drug designation to dusquetide, the active pharmaceutical ingredient in SGX945, for the treatment of Behçet’s disease.
Behçet’s disease is a rare inflammatory disorder that can affect blood vessels throughout the body and can cause painful mouth and genital sores, skin lesions, eye inflammation and other complications. Because the disease is driven by abnormal immune system activity, flare-ups can be painful, disruptive and difficult to control.
SGX945 is designed to regulate the body’s immune response. In simple terms, the drug is intended to calm excessive inflammation by helping the immune system respond in a more controlled way. The goal is not to attack cancer cells, as HyBryte does, but to reduce the inflammatory overreaction that contributes to symptoms and flare-ups in Behçet’s disease.
The company said the European designation followed a positive recommendation from the European Medicines Agency’s Committee for Orphan Medicinal Products and a review of Phase 2a clinical results that it said demonstrated biological efficacy and safety in patients with Behçet’s disease.
Soligenix also said SGX945 has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for the same condition, adding regulatory support on both sides of the Atlantic.
According to the company, orphan drug designation in the European Union provides a 10-year period of marketing exclusivity after approval, along with other incentives that can include regulatory assistance and certain fee reductions. For smaller biotech firms developing drugs for rare conditions, those incentives can be important because they may improve the economics of bringing a treatment to market.
Recent company updates have pointed to what Soligenix sees as a potentially important year ahead. In a March 31 investor release, President and CEO Christopher J. Schaber said the company is “entering a pivotal year with several high-impact clinical and regulatory milestones” across its pipeline, including anticipated interim and top-line results from the Phase 3 FLASH2 trial of HyBryte later in 2026, according to published reports.
Published reports also note that Soligenix expects additional clinical data readouts and is evaluating possible partnership, financing and other strategic options to advance its programs.
The company reported it ended 2025 with approximately $7.9 million in cash and said it expects current resources to fund operations into late 2026, according to published reports.
Soligenix trades on Nasdaq under the symbol SNGX and focuses on developing and commercializing treatments for rare diseases where there is an unmet medical need.
