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HyBryte™ Clinical Results Demonstrate Continued Improvement Post-Treatment
Monday, 2nd December at 7:30 am
Significant Efficacy against Plaque Lesions Also Demonstrated with HyBryte™
PRINCETON, N.J., Dec. 2, 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 that analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte™ (synthetic hypericin) to Valchlor® (mechlorethamine) has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment.
Monday, 2nd December at 7:30 am
Significant Efficacy against Plaque Lesions Also Demonstrated with HyBryte™
PRINCETON, N.J., Dec. 2, 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 that analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte™ (synthetic hypericin) to Valchlor® (mechlorethamine) has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment.
The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response rate (60% in the HyBryte™ group vs. 20% in the Valchlor® group) at the end of treatment.
After the 4-week follow-up period (Week 16), the majority (3 of 5) of HyBryte™ patients continued to demonstrate improvement with at least a further 10% improvement (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of the HyBryte™ patients achieving a "complete response".
In contrast, of the four patients that completed the Valchlor® arm of the study, none achieved this level of improvement by Week 16.
For patients, a treatment response was defined as a ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score over 3 to 5 lesions. Treatment response was also assessed on individual lesions. There was a similar continued improvement in the lesion responses over time, with the plaque lesions of particular interest given their increasing association with risk of overall disease progression and long-term mortality.
At the 12-week (end of treatment) timepoint, the HyBryte™ treated plaque lesions were statistically significantly improved compared to the Valchlor® treated plaques (63%, [10/16] treatment success with HyBryte™ vs. 17%, [2/12] with Valchlor®, p=0.02). By Week 16, the response rates in lesions treated with HyBryte™ were statistically significant responses for all lesions (72% HyBryte™ vs 28% Valchlor®, p=0.02) and specifically for plaque lesions (75% responding plaque lesions with HyBryte™ treatment vs. 17% with Valchlor®, p=0.006) relative to the Valchlor® group.
No safety concerns with HyBryte™ were raised during the follow-up period.
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