NASDAQ:SNGX
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Business Update
Phase 3 FLASH2 Trial of HyBryte in CTCL is Underway
On December 16, 2024, Soligenix, Inc. (NASDAQ:SNGX) announced that patient enrollment has opened up for the confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) trial of HyBryte™ in patients with cutaneous T cell lymphoma (CTCL).
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. One key difference between the trials is that in the FLASH trial patients were treated for three cycles of six-weeks each, with a two-week break in between cycles and the primary efficacy endpoint was measured after the first treatment cycle, while in the FLASH2 trial patients will be treated for 18 consecutive weeks before the primary efficacy endpoint is assessed. Based on this, we believe the trial has a high probability of success given the response rate at 18 weeks in the FLASH study (49%, P<0.0001 vs. placebo).
The randomized, double blind, placebo controlled, multicenter trial is expected to enroll approximately 80 patients with CTCL across the U.S. and E.U. Extending the treatment period for 18 consecutive weeks before assessing the primary efficacy endpoint is expected to show the efficacy of HyBryte over a more prolonged, “real world” treatment course that is typical for CTCL patients. We anticipate trial updates from the company throughout 2025.
HyBryte Shows Continued Improvement Post-Treatment in Comparator Trial
On December 2, 2024, Soligenix announced the analysis of post-treatment data from the open label study comparing HyBryte to Valchlor® (protocol HPN-CTCL-04). The company had previously announced results from this study in June 2024, which showed that 60% of patients treated with HyBryte achieved “treatment success” compared to 20% of Valchlor-treated patients after 12 weeks of treatment. Following the four-week follow-up period, an additional at least 10% improvement was noted in three out of the five HyBryte-treated patients, with one patient achieving a “complete response”. Of the four patients treated with Valchlor, during the four-week follow-up period one patient worsened, one had a modest decrease, one remained static, and one had a modest improvement.
Lesion responses also continued to improve over time. At the 12-week timepoint, the HyBryte-treated plaque lesions were statistically significantly improved compared to the Valchlor-treated plaque lesions (63% [10/16] with HyBryte vs. 17% [2/12] with Valchlor, P=0.02). By week 16 this improved to 75% for the HyBryte-treated plaque lesions compared to 17% with Valchlor (P=0.006). There were no new safety concerns noted for HyBryte during the follow-up period and it was well tolerated during the study, while one of the five patients treated with Valchlor had to be withdrawn during the trial due to a clinically significant contact dermatitis from Valchlor.
Phase 2 Trial of SGX945 in Behcet’s Disease Initiates
On November 14, 2024, Soligenix announced the initiation of the Phase 2 trial of SGX945 (dusquetide) for the treatment of Behcet’s disease. This pilot, open label study is expected to enroll approximately 25 patients age 18 years or older with mild to moderate Behcet’s Disease and active oral and/or genital ulcers. SGX945 will be administered as a twice-weekly 4-minute intravenous infusion for four weeks followed by four weeks of follow-up. Efficacy endpoints include lesion clearance, time to lesion clearance, and patient reported quality of life assessments. We anticipate topline results in the first half of 2025.
Conclusion
We’re glad to see the company has initiated the confirmatory Phase 3 trial for HyBryte in CTCL and we look forward to updates on the trial during 2025. We are very confident in a positive outcome in the trial based on the results from the FLASH trial and the fact that patients will be treated for a longer, continuous time. Looking ahead to next year, we continue to expect data from the ongoing Phase 2 trial of SGX302 in mild-to-moderate psoriasis and the Phase 2 trial of SGX945 in Behcet’s disease in the first half of 2025. With no changes to our model our valuation remains at $35 per share.
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