Exclusive: Vyome Biosciences set for regulatory filing for new acne treatment by year-end

India-based Vyome Biosciences plans a regulatory filing by the end of the year with US Food and Drug Administration for its lead molecule (VB 1953), which targets the vast drug resistant acne prescription market, co-founder and chief executive N Venkat told The Pharma Letter in an exclusive interview.

“The product will move into the clinics in the next quarter. Subsequently, we expect Phase I, Phase II be done in one-and-a-half years. Then we will have a big serious, value inflection after which we might licence it out or we might raise money in the US to take it to Phase III," said Mr Venkat.

Mr Venkat says the company is in a very unique place in the dermatology segment, given the space of research Vyome Biosciences is invested in. “We are actually looking at some of these microbes that actually cause this opportunistic infection and some of them are very hard to treat. The idea is to understand the reason for this resistance by studying the genetic makeup of these microbes. Then from there [go on to] develop IP-based platform technologies, pharmaceutical as well as OTC (over the counter) products," he said.