The primary objective of the study is to compare efficacy, tolerability and safety of VB 1953 in Patients with Moderate to Severe Acne
Vyome Biosciences has completed enrollment in its proof-of-concept study of VB 1953, a topically administered gel, for patients with moderate to severe acne. The first patient was dosed in January and results are expected to be available later this year.
A total of 161 patients with moderate to severe acne have been enrolled in the randomised, double-blind, vehicle-controlled study being conducted in three sites in Central America and the Dominican Republic.
The primary objective of the study is to compare efficacy, tolerability and safety of VB 1953 versus vehicle gel applied topically once or twice daily for up to 12 weeks. The primary endpoints of the study are change in inflammatory and non-inflammatory lesions from baseline to week 12, as well as percentage of patients with IGA success to week 12, compared to vehicle.
“In prior studies, VB 1953 has shown potential to treat moderate to severe acne with a promising dermal safety signal and tolerability, and we look forward to demonstrating efficacy in this proof-of-concept clinical study as we work to develop a much-needed therapeutic option for these patients,” said Venkateswarlu Nelabhotla, Co-founder and CEO, Vyome Biosciences.