- Soligenix reported that SGX302 was well tolerated by all patients in cohort 3, with no drug-related adverse events identified during the treatment period.
- An optimized gel formulation was designed to improve the patient experience, with both easier dispensation and skin application.
- SGX302 utilizes visible light-activated synthetic hypericin, a first-in-class photodynamic therapy mechanism.
Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases where unmet medical need exists, announced extended top line results from its Phase 2a clinical trial of SGX302 (synthetic hypericin) in patients with mild-to-moderate psoriasis. The updated findings highlight clinical improvements with an optimized gel formulation of the investigational therapy, underscoring the potential of SGX302 as a noncarcinogenic, photodynamic treatment.
According to the company, the Phase 2a trial has progressed into an extension cohort (cohort 3) that enrolled an additional four patients treated with an improved topical gel formulation of SGX302. SGX302 gel was applied to psoriasis lesions twice a week over an 18-week period, the same duration as prior cohorts in the study. The gel formulation was designed to improve ease of application, particularly for larger or more extensive areas of affected skin.
Soligenix reported that SGX302 was well tolerated by all patients in cohort 3, with no drug-related adverse events identified during the treatment period. Among the three evaluable patients (one patient discontinued for personal reasons unrelated to the therapy), improvements were observed across multiple clinical measures. Measures used included the Investigator Global Assessment (“IGA”) and the Psoriasis Activity and Severity Index (“PASI”), standard scales used in dermatology to quantify disease severity and response to treatment.
One patient reached a disease status categorized as “Almost Clear” on the IGA scale, which is widely regarded as a marker of meaningful clinical success in psoriasis studies. This was accompanied by a substantial PASI improvement exceeding 50%, a benchmark that developers and clinicians consider evidence of therapeutic effect in skin disease trials. The outcomes seen with the optimized gel formulation were described as similar to or improved relative to prior responses seen with earlier SGX302 ointment formulation, consistent with expectations given the comparable release characteristics of the drug and the improved ease of application inherent to the gel.
“We are pleased with the preliminary findings from our ongoing Phase 2a trial,” said Soligenix president and CEO Christopher J. Schaber. “The optimized gel formulation was designed to improve the patient experience, with both easier dispensation and skin application. The expansion of this psoriasis study continues our evaluation of synthetic hypericin into other disease indications, including non-orphan indications, where there remains an unmet medical need.” Schaber also emphasized that the expansion of the psoriasis study continues the company’s evaluation of synthetic hypericin in indications beyond those historically targeted, addressing disease settings with large populations and significant unmet needs.
Current estimates show as many as 60 million to 125 million people worldwide living with psoriasis, a chronic inflammatory skin disease that can greatly impact quality of life. Psoriasis was projected to represent a global treatment market valued at approximately $15 billion in 2020, with forecasts suggesting the market could reach as much as $40 billion by 2027.
SGX302 utilizes visible light-activated synthetic hypericin, a first-in-class photodynamic therapy mechanism. Unlike some traditional photodynamic therapies that activate with ultraviolet (“UV”) light, which can be associated with DNA damage and long-term safety concerns, SGX302’s use of the red-yellow spectrum of visible light may provide deeper tissue penetration and a safer profile. The therapy works by absorbing visible light to induce apoptosis (programmed cell death) in target cells, addressing the underlying dysregulated immune activity in psoriasis lesions. This mechanism is conceptually similar to that observed in the positive Phase 3 FLASH study of synthetic hypericin in cutaneous T-cell lymphoma.
The ongoing Phase 2a study has enrolled sequential cohorts, each treated over an 18-week regimen. In cohort 1, five patients were treated with a 0.25% SGX302 ointment formulation applied twice weekly, followed by visible light activation approximately 24 hours later. While the initial cohort demonstrated biological signal and generally tolerated therapy well with improvements in PASI scores, none of the cohort reached a predefined clinical success threshold (IGA score of 0 or 1) by week 18 under the original dosing protocol.
Based on safety and tolerability observed in cohort 1, the second cohort was enrolled with an accelerated visible light dosing schedule allowing higher doses to be reached earlier in the treatment cycle. Among the four evaluable patients in cohort 2, two achieved clinical success at some point during the 18-week period and all demonstrated improvement, averaging about a 50% reduction in PASI score, further validating the biological activity of SGX302 across formulations and dosing strategies.
Soligenix’s SGX302 program is part of the company’s broader pipeline exploring synthetic hypericin in both rare and more common disease indications. In addition to mild-to-moderate psoriasis, synthetic hypericin is also being pursued under the name HyBryte(TM) in late-stage development for cutaneous T-cell lymphoma (“CTCL”), an orphan dermatologic cancer with high unmet need. A confirmatory Phase 3 study of HyBryte continues to advance, and topline results are expected as part of the company’s clinical roadmap in 2026.
The positive data from cohort 3 support continued development of SGX302 as a noncarcinogenic, nonmutagenic photodynamic therapeutic. The demonstrated improvements in clinical endpoints and quality of life measures with the optimized gel form reinforce the potential for the therapy to expand into commercial development pathways, especially if confirmatory Phase 3 trials replicate and extend these early results.
As psoriasis remains a prevalent chronic disease with limited curative options, the announcement of these extended Phase 2a results represents a meaningful milestone for Soligenix and an important step forward in the broader validation of synthetic hypericin as a therapeutic platform. With data indicating improved application characteristics, strong tolerability and clear biological signals of efficacy, the company is poised to pursue further clinical advancement while navigating regulatory and commercial strategy in indications with significant unmet patient need.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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