Veloce BioPharma announced positive results of its Phase 2b study of dilute povidone-iodine in a novel DMSO solvent system for the topical treatment of chemotherapy-associated paronychia, or painful and inflamed nail units resulting as a side effect of chemotherapy.
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The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study was designed to evaluate the safety, tolerability and efficacy of two strengths of VBP-926 (1% PVP-I, 2% PVP-I) vs. vehicle in 102 subjects with chemotherapy-associated paronychia. Results from the study showed that VBP-926 (2%) met the primary efficacy endpoint of grade-improvement on the Paronychia Severity Grading Scale. Consistent with previously reported case series results, VBP-926 was well-tolerated at both doses and provided both morphological resolution and symptomatic relief in affected nails.
"This trial clearly demonstrated the clinical benefit of VBP-926 2% solution," said Dr. Kara Capriotti, MD, President and Director of Dermatology programs at Veloce. "We are well positioned to move VBP-926 into Phase 3 development and continue advancing a product that targets an indication with no approved therapies. Addressing the pain and discomfort suffered by patients with chemotherapy-associated paronychia is an enormous unmet need and we are encouraged to be getting closer to a topical therapy that can solve this problem."
Phase 2b results showed that VBP-926 at the higher concentration met the primary efficacy endpoint. The 2% dose reached statistical significance for nail grade improvement from baseline to the end of therapy for change in the Paronychia Severity Grading Scale (p=.0003). No treatment-related serious adverse events were reported. Adverse events were mild in severity and reversible when treatment was discontinued.
"Chemotherapy-associated paronychia is a frequent side effect of cancer treatments, and may impair quality of life and administration of anti-cancer treatments,” Mario Lacouture, MD, Director, Oncodermatology Program at Memorial Sloan Kettering Cancer Center and Lead Investigator of the trial, said. “This study is of interest, as it showed a significant reduction in paronychia score at the higher concentration of VBP-926 solution." Dr. Lacouture's research was funded by Veloce BioPharma.
VBP-926 is a broad-spectrum, resistance-free biocidal topical solution that has the ability to eradicate all known microorganisms including bacteria, viruses, yeasts, molds, fungi and protozoa.