Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, 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 randomized, double-blind, vehicle-controlled study being conducted in three sites in Central America and the Dominican Republic. The study is comprised of four arms. In arm one of the study, 64 patients will receive the 2 per cent VB 1953 topical gel applied once daily, while in the second arm, 64 patients will apply the 2 per cent VB 1953 topical gel twice daily. In the third and fourth arms, 32 patients in each arm will receive vehicle gel once or twice daily, respectively.
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 (N. Venkat), co-founder and chief executive officer of Vyome Biosciences.
VB 1953 is a potent next-generation antibiotic and anti-inflammatory compound combined with a patented micro-technology gel system designed to maximize effect at the site of infection and minimize systemic exposure. As a topical treatment option, VB 1953 exerts an anti-inflammatory effect and impedes the development of resistance. In a US-based phase 1 clinical trial conducted in 12 patients with moderate to severe acne receiving 14 days of treatment, VB 1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability. In addition to demonstrating safety, treatment with VB 1953 resulted in a reduction of inflammatory and non-inflammatory lesions, as well as a reduction in IGA scores, compared to baseline that were suggestive of a potential efficacy signal.
Following completion of the proof-of-concept study, Vyome plans to initiate a phase 2B trial to further evaluate VB 1953 for the treatment of moderate to severe acne by the end of 2017.