- Nearly half of all patients in Phase 3 trial continue to see sustained and statistically significant improvement in their response rates when treated with SGX301 through 18 weeks (Cycle 3), reinforcing positive SGX301 primary endpoint treatment response
- SGX301 remains safe and well tolerated with no systemic exposure through 6 months including the optional, final cycle of the trial (Cycle 3)
- SGX301 demonstrates statistically significant response in both patch and plaque lesions through 12 weeks of treatment (Cycle 2), highlighting the unique benefits of deeper skin penetration
Princeton, NJ – Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to significantly improve responses and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study. This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further improved response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or greater reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients demonstrating such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046). In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study has revealed that 12 weeks of treatment (Cycle 2) with SGX301 is equally effective on both patch (response 37%, p=0.0009) and plaque (response 42%, p<0.0001) lesions of cutaneous T-cell lymphoma (CTCL) when compared to Cycle 1 placebo lesion responses, further demonstrating the unique benefits of the more deeply penetrating visible light activation of hypericin. SGX301 continued to be very well tolerated, benefiting from the lack of hypericin circulation in the blood stream after targeted topical application to the lesions, as well as the use of visible light.