By David Bautz, PhD
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Business Update
Interim Data from IIS Study Shows 75% Response Rate and Three Complete Responses
On April 14, 2025, Soligenix, Inc. (NASDAQ:SNGX) announced interim data from the ongoing, open label, investigator-initiated study (IIS) of HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T cell lymphoma (CTCL). Thus far, eight patients could be evaluated through Week 18. The results show that six (75%) achieved ‘treatment success’, which is defined as a ≥50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to baseline. In addition, four patients have completed the 54-week treatment period and showed an average maximum improvement in mCAILS score of 85%. Three other patients are still on treatment and one patient dropped out of the trial due to a logistical issue. In addition to the 75% treatment success rate, thus far three patients have achieved a complete response. Lastly, HyBryte continues to appear to be safe and well tolerated in all patients.
The 75% treatment success rate at 18 weeks in the IIS is important since the company is currently conducting the FLASH2 trial of HyBryte in approximately 80 CTCL patients. The FLASH2 trial is evaluating the primary endpoint of treatment success after 18 weeks of treatment. A comparison of the successful FLASH trial and the ongoing FLASH2 trial are given below:
These IIS results add to our confidence that the FLASH2 trial will ultimately be a success, and with many other CTCL therapies taking six to 12 months to generate a clinically meaningful response, we believe results like these for HyBryte support its eventual commercial success, if approved.
Conclusion
The data updates for HyBryte continue to show CTCL patients achieving treatment success in a relatively short timeframe while being a safe and well tolerated therapy. We look forward to additional updates from the IIS study as well as the FLASH2 trial as the year progresses. In addition, we anticipate results from the Phase 2 trial of SGX302 in mild-to-moderate psoriasis and SGX945 in Behcet’s disease. With no changes to our model, our valuation remains at $35 per share.
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