Clinical-stage specialist pharmaceutical company Vyome Biosciences has reported positive top-line results from the Phase I clinical trial of topical VB-1953 to treat patients with moderate-to-severe acne.
VB 1953 is an antibiotic developed as an topically administered gel for the treatment of antibiotic resistant acne using its bactericidal anti-inflammatory activity and to inhibit the development of resistance.
Conducted in San Diego, US, the Phase I trial was designed to evaluate the safety, efficacy and tolerability of VB-1953 in 12 patients for a period of 14 days.
Vyome Biosciences co-founder and chief executive officer Venkateswarlu Nelabhotla said: "This data is encouraging for patients with moderate-to-severe acne, especially the one-third 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.”
The results from the trial showed positive tolerability and efficacy. It is found that the drug can reduce the inflammatory and non-inflammatory lesions.
The drug achieved dermal tolerability and a plasma concentration of less than 1ng/ml, in addition to demonstrating safety.
The firm has combined the antibiotic with a patented micro-technology gel system to ensure that the active drug ingredient is retained at optimum levels at the site of infection and decreases systemic exposure.
Vyome Biosciences develops pathogens, antifungal agents and drugs for dermotological conditions such as antibiotic resistant acne. The firm leverages its patented Dual Action Rational Therapeutics (DARTs) technology to overcome the development of resistance.