Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, today 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 mg/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.

Approximately 240 million people are diagnosed with moderate to severe acne, with nearly 40 percent of those patients suffering from 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, including 85 percent of teenagers.

VB 1953 is Vyome Biosciences’ lead drug candidate focused on the treatment of antibiotic resistant acne entering phase 2 studies to treat moderate to severe facial acne vulgaris. As a topical treatment option, VB 1953 exerts an bactericidal anti-inflammatory effect and impedes the development of resistance. Vyome merges this next-generation antibiotic with a patent-protected micro-technology gel system that ensures the active drug ingredient is retained at optimum levels at the site of infection and minimizes systemic exposure.

Vyome Biosciences is an innovation-driven, clinical stage specialty pharmaceutical company, which has novel platforms technologies and a deep pipeline of novel drugs for antibiotic resistant acne, other opportunistic pathogens and antifungal agents in dermatology. Vyome has a deep pipeline of preclinical new chemical entities, unique in their ability to overcome the development of resistance based on its patented Dual Action Rational Therapeutics (DARTs) technology. The company has developed clinically proven antifungal products based on innovative technology platform Molecular Replacement Therapy (MRT).