Soligenix Announces Promising Interim Results for Extended HyBryte™ Treatment in Cutaneous T-Cell Lymphoma Study; Shares Surge over 200% Premarket

Results Show Sustained Efficacy and Safety in Extended Treatment of CTCL

Soligenix, Inc. (Nasdaq: SNGX), a late stage biopharmaceutical company, has released an interim update on an ongoing study for HyBryte™ in treating early-stage cutaneous T-cell lymphoma (CTCL). The study, led by Dr. Ellen Kim of the Hospital of the University of Pennsylvania, is supported by a $2.6 million FDA Orphan Products Development Grant and explores the extended use of HyBryte™ up to 12 months.

Study Highlights:

• Enrollment and Treatment: Six patients have been enrolled, with treatments spanning up to 44 weeks. Three out of four patients completing at least 12 weeks of therapy have achieved “Treatment Success,” defined as a ≥50% improvement in their cumulative mCAILS score from Baseline.
• Early Successes: Of the successes, two were recorded within the first 12 weeks of treatment, and one at 18 weeks.
• Safety Profile: To date, HyBryte™ has been well-tolerated by all participants, with no treatment-related adverse events reported.

This ongoing investigator-initiated study (IIS) aims to gather real-world data to support the use of HyBryte™ beyond the controlled clinical trial setting. This data will supplement findings from previous Phase 2 and Phase 3 trials, which have already demonstrated the treatment’s efficacy and safety. Notably, a recent 12-week comparability study showcased HyBryte™ outperforming the standard of care, Valchlor®, with a more favorable safety profile and superior treatment response.

Lead Investigator’s Perspective: “In the Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a promising safety profile. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our U.S. Food and Drug Administration (FDA)-funded study, initial results evaluating the expanded use of HyBryte™ in a ‘real world’ treatment setting are promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials,” noted Dr. Kim, Principal Investigator of the IIS. “We look forward to continuing to work with the FDA to complete this study and to participating in the upcoming confirmatory Phase 3 placebo-controlled study.”

CEO’s Perspective: “We are pleased with the initial study results and with the FDA’s support of the IIS that provides CTCL patients an opportunity to access HyBryte™ in an open-label setting,” stated Christopher J. Schaber, President and CEO of Soligenix, Inc. “CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. Following the initial Phase 3 FLASH study which demonstrated the safety and efficacy of shorter courses of HyBryte™ therapy, we are pleased to see that continuing treatment for longer time periods is resulting in the anticipated improved outcomes for patients. As the body of compelling data continues to grow in support of this novel therapy, we look forward to working with Dr. Kim on this important study as well as embarking on our confirmatory Phase 3 replication study later this year. We will continue to provide additional updates on the IIS as data becomes available.”

The study, titled RW-HPN-MF-01 “Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients,” is still enrolling and may include up to 50 participants across selected U.S. clinical centers. The primary endpoint is the number of treatment successes as defined by significant reductions in the mCAILS score from baseline. These early results reinforce the positive data from the previously completed Phase 3 FLASH study, confirming HyBryte™’s efficacy over a short treatment period. Soligenix is also preparing to initiate a second Phase 3 study, FLASH2, in response to EMA feedback and is in discussions with the FDA to finalize HyBryte™’s development pathway to potential marketing approval worldwide.