By David Bautz, PhD
NASDAQ:SNGX
READ THE FULL SNGX RESEARCH REPORT
Business Update
Expanding SGX302 Phase 2a Study in Mild-to-Moderate Psoriasis
On July 11, 2023, Soligenix, Inc. (NASDAQ:SNGX) announced that the company will be expanding the ongoing Phase 2a clinical trial of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis. A clear biological signal was seen following evaluation of the first five subjects enrolled in the trial as evidenced by an improvement in the PASI (psoriasis area and severity index) score. At least an additional five patients will now be enrolled into the trial, which will allow Soligenix to evaluate SGX302 in the context of accelerated light treatment and additional adjunct treatment. We anticipate results from the Phase 2a trial before the end of 2023.
The Phase 2a trial is a randomized, double blind, placebo controlled study this is enrolling patients with mild-to-moderate, stable psoriasis covering 2% to 30% of their body. Placebo or SGX302 is being administered twice weekly for up to 18 weeks, with each treatment consisting of application followed approximately 24 hours later with visible light activation. The efficacy endpoints include lesion clearance along with patient quality of life indices.
Update on FDA Interactions for HyBryte
In April 2023, Soligenix conducted a Type A meeting with the FDA regarding the design of a second Phase 3 clinical trial for HyBryte in the treatment of cutaneous T cell lymphoma (CTCL). The FDA will require a second, confirmatory study with a longer comparative treatment duration than was conducted in the FLASH study to support an NDA filing for HyBryte in CTCL. We spoke with Soligenix management and learned that while they do not have a final FDA agreement as yet, they remain in active discussions with the FDA and will be communicating the outcome of these interactions as soon as possible once they have definitive clarity. Dr. Schaber noted that, while he had hoped the process would have moved a bit quicker, it’s important to maintain positive and productive dialogue when working to gain potential agreement on a feasible and highly executable clinical trial design. The company anticipates having that clarity before the end of the year and will update investors as soon as possible.
Conclusion
The initial results from the Phase 2a psoriasis trial are encouraging and we look forward to the full results before the end of 2023. In addition, we anticipate the company providing additional clarity on the second Phase 3 clinical trial for HyBryte in CTCL before the end of the year. With no changes to our model, our valuation remains at $3.50 per share.
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