Vyome’s acne treatment demonstrates positive phase 2 results
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VB-1953, a first-in-class topical bactericidal and TLR-MD2 inhibitor, showed a statistically significant difference in inflammatory lesions in the treatment of moderate to severe acne, according to a press release from Vyome Therapeutics.
The phase 2 randomized, multicenter, double-blind, dose-ranging trial evaluated the safety and efficacy of VB-1953 gel when applied once or twice daily for 12 weeks. It included 471 subjects across 13 U.S. sites.
“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,” Shiladitya Sengupta, PhD, scientific co-founder of Vyome, said in the release.
In the intent to treat group, the mean absolute inflammatory lesion change in the VB-1953 once-daily group was 20.4 compared with 17.8 in the vehicle group (P < .003). In the per protocol group, the mean change was 20.4 in the treatment arm and 16.6 in the vehicle arm (P < .001).
“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, and our data shows a very high response, which is encouraging as we plan to advance to phase 3 with a once-daily dose,” Vyome CEO Venkat Nelabhotla said in the release.
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