NASDAQ:SNGX
READ THE FULL SNGX RESEARCH REPORT
Business Update
Additional Positive Data for IIS of HyBryte in CTCL
On January 14, 2025, Soligenix, Inc. (NASDAQ:SNGX) announced additional positive data from the open-label, investigator-initiated study (IIS) of HyBryte (synthetic hypericin) for patients with cutaneous T cell lymphoma (CTCL) for up to 12 months. During the study patients are treated twice a week and the protocol allows for the potential transition to a “real-world” setting with at-home use. The trial is being sponsored by Dr. Ellen Kim, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania and is being funded by a $2.6 million Orphan Products Development Grant from the FDA.
Thus far, nine patients have been enrolled into the study, with six patients having completed at least 18 weeks of therapy. Of those six, five have achieved “treatment success”, which is defined in the study protocol as a ≥50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to baseline. Of the five treatment successes, three were achieved within the first 12 weeks of treatment and two have achieved a “complete response” by 18 weeks. Of the remaining patients, two recently started the study and two had to drop from the study for logistical reasons, although one of those showed a substantial improvement (>30%) by 18 weeks. Importantly, HyBryte continues to be safe and well tolerated.
To put these results into context, the following chart shows the response rate seen for HyBryte treatment from different studies that examined various treatment lengths. The data shows that there appears to be a direct correlation between treatment length and response rate, and extrapolating these results to the recently initiated Phase 3 FLASH2 trial (in which patients will receive treatment twice a week for 18 weeks) shows that a response rate of approximately 80% for those treated with HyBryte is likely.
Conclusion
We continue to be very encouraged by the results from studies testing HyBryte as a treatment for CTCL. The results announced today show that extended treatment with HyBryte is leading to improved outcomes for patients. We anticipate additional updates from this study as more data becomes available. In addition, the company recently initiated the Phase 3 FLASH2 trial, and we expect updates on the progress of that trial later in 2025. With no changes to our model our valuation remains at $35 per share.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
