Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, announced top-line data from its phase 1 clinical trial evaluating VB-1953, a topically administered gel designed to treat patients with moderate to severe acne. VB-1953 exhibited a promising dermal safety signal, was generally well tolerated and showed the potential to treat moderate to severe acne.
According to a preliminary analysis of the data from 12 patients, VB-1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. Also, in addition to demonstrating safety in this 12-patient study, treatment with VB-1953 resulted in a reduction of inflammatory and non-inflammatory lesions and in IGA scores, compared to baseline, suggested a potential efficacy signal in these moderate to severe acne patients.
"VB-1953 was generally well tolerated with a good dermal safety signal and the early parameters of efficacy were encouraging after only a short duration of treatment," said study investigator Neal Bhatia, MD, of Therapeutics Clinical Research in San Diego, CA. "Based on these results, VB-1953 appears to demonstrate the potential to be a promising new treatment as further development continues."
"These data are encouraging for patients with moderate to severe acne, especially the one-third of whom do not respond to available treatment options due to microbial resistance. With a promising dermal safety signal, and potential anti-acne and anti-inflammatory activity, VB-1953 has the potential to fill this gap in acne treatment," said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.
Trial patients received VB 1953 twice daily for a treatment period of 14 days following a required screening period. The clinical study was conducted in San Diego.