Soligenix Reports Positive Interim Findings from Investigator-Initiated Study, Highlighting Safety and Efficacy in Real-World Setting
Soligenix (SNGX), a late-stage biopharmaceutical company dedicated to developing and commercializing therapies for rare diseases, has announced encouraging interim results from an ongoing open-label, investigator-initiated study (IIS) of HyBryte. The study evaluates extended treatment of up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is led by Dr. Ellen Kim, Director of the Penn Cutaneous Lymphoma Program and a prominent figure in the Phase 3 FLASH study for early-stage CTCL.
As of now, six patients have been enrolled and treated with HyBryte™ for up to 44 weeks. The interim results are promising, with 75% of the patients (3 out of 4 who have completed at least 12 weeks of therapy) achieving “Treatment Success.” This success is defined by the study’s protocol as a 50% or greater improvement in the cumulative modified Composite Assessment of Index Lesion Severity (mCAILS) score from baseline. Notably, two of these patients reached the success threshold within the first 12 weeks, and the third within 18 weeks. Among the remaining patients, two have recently begun treatment and have yet to reach their first efficacy evaluation at Week 6, while one patient showed significant improvement at Week 18 but has not yet met the success criteria.
Importantly, HyBryte has demonstrated a favorable safety profile, with no treatment-related adverse events reported to date. This is consistent with findings from the Phase 3 FLASH study, which also highlighted the efficacy and safety of HyBryte.
Dr. Ellen Kim, the Principal Investigator of the IIS, stated, “In the Phase 3 FLASH study, HyBryte showed promising efficacy with a strong safety profile. Given the limited treatment options available, particularly in the early stages of CTCL, patients are in need of alternative therapies. The initial results of our FDA-funded study in a real-world setting further support and extend the positive outcomes from previous Phase 2 and 3 trials. We are eager to continue collaborating with the FDA to complete this study and to participate in the forthcoming confirmatory Phase 3 placebo-controlled study.”
Christopher J. Schaber, President and CEO of Soligenix, Inc., expressed his satisfaction with the interim results and the FDA’s support. “We are pleased with the initial study outcomes and the opportunity the IIS provides for CTCL patients to access HyBryte in an open-label setting. CTCL is a challenging orphan disease with few safe and effective treatment options. Following the initial Phase 3 FLASH study, which demonstrated the safety and efficacy of shorter HyBryte therapy courses, we are encouraged to see that extended treatment is yielding improved outcomes. As more compelling data emerges in support of this novel therapy, we look forward to working with Dr. Kim on this critical study and initiating our confirmatory Phase 3 study later this year. We will continue to provide updates as new data becomes available.”
The clinical study, RW-HPN-MF-01, titled “Assessment of Treatment with Visible Light Activated Synthetic Hypericin Ointment in Mycosis Fungoides Patients,” is designed as an open-label, multicenter trial aiming to enroll up to 50 patients across select U.S. clinical centers. Patients can be treated for up to 12 months with twice-weekly dosing, involving visible light activation 24 ± 6 hours post-ointment application. The study also explores the potential transition to a real-world setting with home-use administration. The primary endpoint is the number of treatment successes, defined as a 50% or greater reduction in the cumulative mCAILS score from baseline to the end of treatment.
In summary, the interim results of the IIS indicate that HyBryte could be a valuable treatment for early-stage CTCL, offering a combination of efficacy and safety in a real-world setting. As Soligenix continues to gather data and work towards the confirmatory Phase 3 study, the potential for HyBryte to address the unmet medical needs of CTCL patients remains strong.
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