New Delhi based Vyome Biosciences, a clinical-stage specialty biopharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, announced that it administered the first in-human dose of its lead candidate VB 1953 in its phase 1 clinical trial being conducted in the United States to treat patients with moderate to severe facial acne.
This open-label study is designed to evaluate the safety, tolerability and pharmacokinetics of VB 1953, a topically administered gel developed to treat patients with moderate to severe acne. According to the study protocol, VB 1953 will be administered twice daily for a treatment period of 14 days following a 30-day screening period. The clinical study, which is being conducted by a CRO (Therapeutics Inc.), continues to enroll patients at a single clinical site; Therapeutics Clinical Research, in San Diego, CA.
“Microbial resistance often limits the effectiveness of treatment of moderate to severe acne. We are looking forward to evaluating VB 1953 in this patient population,” said Investigator Neal Bhatia, MD, of Therapeutics Clinical Research.
"One-third of patients with moderate to severe acne do not respond to available treatment options which is due, at least in part, to microbial resistance. We believe VB 1953 can address this significant unmet need. This milestone is an important step in that direction,” said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.
Approximately 240 million people are diagnosed with moderate to severe acne globally, and studies show that nearly 40 per cent of these patients are affected by antibiotic resistance. According to the American Academy of Dermatology, acne represents the most common skin disease, affecting 40-50 million people in the United States alone, including 85 per cent of teenagers.
VB 1953 is Vyome Biosciences’ lead program focused on the treatment of antibiotic resistant acne. It is currently in evaluation in US FDA phase 1 clinical studies. As a first-in-class topical treatment option, VB 1953 has bactericidal properties, addresses antibiotic resistance and also exerts an anti-inflammatory effect. Vyome has developed the product using micro-technology gel system that optimizes skin deposition and minimizes systemic exposure.