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Phase 3 CTCL Trial to Initiate Before End of 2024
Soligenix, Inc. (NASDAQ:SNGX) is on track to initiate a confirmatory Phase 3 trial of HyBryte for the treatment of cutaneous T cell lymphoma (CTCL) before the end of 2024. The FLASH2 trial will be very similar in design to the Phase 3 FLASH trial, as shown in the following figure, which provides a comparison between the two studies. This similarity in design increases our confidence in a positive outcome for the FLASH2 trial. With the trial expected to begin enrollment prior to the end of 2024, we anticipate topline results in the second half of 2026. After reaching agreement with the European Medicines Agency (EMA) on the key design elements of the FLASH2 trial, the company is continuing discussions with the U.S. Food and Drug Administration (FDA) on an appropriate study design as the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial.
Results from Additional, Supportive Trials of HyBryte Presented at EORTC
On October 7, 2023, Soligenix announced that findings from recent additional, supportive trials with HyBryte in the treatment of CTCL were presented at the European Organization for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Tumor Group Annual Meeting. The presentations included:
• An oral presentation by Dr. Brian Poligone on results from two expanded treatment studies: HPN-CTCL-02 that showed a lack of significant systemic exposure to hypericin after topical application and HPN-CTCL-04 that showed HyBryte treatment was more effective than Valchlor® along with a more favorable safety profile.
• A poster presentation by Dr. Ellen Kim that presented results from an investigator-initiated study examining longer treatment times with hypericin in CTCL. Thus far, eight patients have enrolled and six are actively receiving treatment (two patients withdrew for logistical reasons). One patient completed 55 weeks, two completed at least 25 weeks, and three completed at least five weeks. Results show that 3/4 (75%) of patients who have received treatment for at least 18 weeks have achieved the primary endpoint of index lesion response rate, defined as ≥50% reduction in mCAILS score of index lesions from baseline to end of treatment. There have been no serious adverse events reported. Enrollment is continuing with the potential to include additional sites.
Partnership Agreement for Hypericin Production
On October 3, 2024, Soligenix announced a manufacturing partnership agreement with Sterling Pharma Solutions for a scalable production technology for synthetic hypericin, which is the active pharmaceutical ingredient in the topical drug product formulations for HyBryte and SGX302. The two companies are currently working to transfer and optimize the manufacturing processes to enable GMP manufacturing and establish a long-term collaboration. The ultimate goal is to reduce the overall cost of goods as the company pushes toward potential commercialization.