Soligenix Announces Top-line Results of the Phase 2a Study of SGX302 (Synthetic Hypericin) in Patients with Mild-to-Moderate Psoriasis
Clinical Success Achieved in Second Cohort of Patients
Excerpt from the Press Release:
PRINCETON, N.J., Jan. 4, 2024 /PRNewswire/ — 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 preliminary top-line results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. In the expanded portion of the trial (Cohort 2), an additional five patients were enrolled and the treatment guidelines for use of light activation were adjusted to allow for a more rapid escalation and higher final dose level of light than in the initial cohort (Cohort 1) of patients, which is expected to more closely mirror the way the drug will eventually be used in a “real world” clinical setting.
The Cohort 2 patients were treated more aggressively than the patients enrolled in Cohort 1 during an 18-week treatment period. SGX302 therapy was well tolerated by all patients with no drug related adverse events identified. In the four evaluable patients from Cohort 2 (one patient withdrew early in the treatment course for personal reasons unrelated to the study), two reached a disease status of “Almost Clear” represented by an Investigator Global Assessment (IGA) score of 1, which is considered the standard clinical measure for treatment success in psoriasis. In addition, the Psoriasis Activity and Severity Index (PASI) score, another well-characterized measure of treatment success, for patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment.
“Having shown that topical synthetic hypericin has biologic activity in patients with mild-to-moderate psoriasis in Cohort 1, we are very pleased that, when the treatment is administered in a similar manner that has proven successful with HyBryte™ in cutaneous T-cell lymphoma (CTCL) patients, we also see evidence of clinical success in patients with psoriasis,” stated Richard Straube, MD, Chief Medical Officer and Senior Vice President of Soligenix.
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