PRINCETON, N.J., June 16, 2020 -- Vyome Therapeutics, a clinical-stage company developing locally-acting, next generation therapeutics for immuno-inflammatory diseases, today announced positive data from its Phase 2 trial of VB-1953, a firstin-class topical bactericidal and TLR-MD2 inhibitor being developed for the treatment of moderate to severe inflammatory facial acne vulgaris. Results from the trial demonstrated a statistically significant difference in the primary endpoint, the mean absolute change in inflammatory lesions at week 12, for VB 1953, when applied once a day (QD) vs. combined vehicle group (p <0.012). In the comparison between the VB1953 QD arm versus vehicle QD, the mean absolute change in the inflammatory lesions at week 12 in the intent to treat (ITT) group showed 20.4 and 17.8 respectively, with p<0.003, and 20.4 and 16.6 respectively in per protocol group with p<0.001. In addition, VB-1953 exhibited an excellent safety profile and there were no drug related adverse or serious adverse events. "These results demonstrate that VB-1953, with its dual mechanism of action directly killing resistant and non-resistant C. acnes strains while blocking inflammation through TLR-MD2 inhibition, has the potential to become a safe and effective topical treatment for facial acne and an alternative to oral, systemic drugs," said Dr. Shiladitya Sengupta, scientific co-founder of Vyome.
The Phase 2 randomized, multicenter, double-blind, dose-ranging study was designed to evaluate the safety and efficacy of VB-1953 topical gel when applied once daily and twice daily for 12 weeks in subjects with moderate to severe inflammatory facial acne vulgaris. The Company enrolled 471 patients across 13 trial sites in the U.S. Once daily (QD) application was found to be as effective as twice daily application in the mean absolute change in the inflammatory lesions.
Venkat Nelabhotla, Chief Executive Officer of Vyome Therapeutics, added, "We are very pleased to have met the primary endpoint of the study, and to demonstrate the continued safety of the molecule. Patients need a highly effective drug, and our data shows a very high response, which is encouraging as we plan to advance to Phase 3 with a once daily dose. We look forward to delivering a next-generation solution to patients."
Although the study was not powered to test for significance in secondary end points, the drug (VB 1953 QD group) achieved a 66.6% mean reduction in inflammatory lesions at week 12 with p<0.020 in ITT and p<0.004 per protocol group versus vehicle group, and a 49.6% successful improvement in the IGA score (minimum two-grade improvement and achieving clear or almost clear IGA score at week 12) with p<0.361 in ITT group and p<0.069 per protocol group versus vehicle group.
Vyome’s lead clinical drug candidate, VB-1953, is a first-in-class, topical, bactericidal small molecule with a novel mechanism of action in acne. VB-1953 reduces inflammatory lesions in C. acnes by blocking inflammatory cytokine production through TLR-MD2 inhibition and has demonstrated the ability to treat antibiotic-resistant C. acnes strains. VB-1953 is the first bactericidal drug candidate to be tested for the treatment of C. acnes. VB-1953 is delivered topically with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. Acne caused by antibacterial-resistant C.acnes currently poses an emerging and unmet need for patients worldwide, with a potential $2B market opportunity in the US alone.
About Vyome Therapeutics
About Vyome Therapeutics Vyome Therapeutics is a Princeton, New Jersey based clinical stage specialty pharmaceutical company working to treat inflammatory diseases of unmet need with locally acting, next-generation therapeutic solutions. Vyome's portfolio of therapeutic assets are identified and developed to address validated targets with novel drugs for site-targeted applications. Vyome has assembled a world-class team of experts.
Craig Tooman, Chief Operating and Chief Financial Officer
Vyome Therapeutics Inc.
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