US FDA accepts Vyome Biosciences' IND...
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Jan
8
ragupathyrenganathan
US FDA accepts Vyome Biosciences’ IND application for acne drug, VB-1953
Pharma News
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Vyome Biosciences, a dermatology focused innovative bio-pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for the initiation of clinical studies for its lead programme VB 1953, a topical therapeutic candidate for the treatment of moderate-to-severe acne. Vyome plans to start the phase I clinical trials very soon.

According to the American Academy of Dermatology, acne represents the most common skin disease, affecting 85 per cent of teenagers and affects 40-50 million people in the US. Approximately 40 per cent of acne patients are suffering from antibiotic resistance. Physicians around the world have cited a large unmet need for new, improved topical therapy options, vis-à-vis the current available topical products. Vyome’s programme VB 1953 targets this large unmet need of an effective topical treatment option.

“Today marks an important milestone for Vyome Biosciences. With US FDA accepting our first IND application for the lead programme VB 1953, we have become a clinical stage company in USA, which is an important value inflection milestone for us. This should pave way for further filings with the US FDA in future. VB 1953 is a first-in-class new product in acne therapy for addressing one of the very important and a large unmet need,” remarked N. Venkat, co-founder & CEO at Vyome.

“Successful IND acceptance of VB 1953 by the USFDA, is a culmination of tremendous efforts by Vyome’s product discovery and development team. I am extremely delighted at Vyome’s significant achievement and look forward to more of them in future,” said Dr. Raghunath Mashelkar, chairman of Vyome’s Board of Directors.

Apart from the lead programme VB 1953, Vyome has a deep R&D pipeline of Dual Action Rational Therapeutics (DARTs) antibiotics that are very less prone to resistance development. Vyome also has a portfolio of clinically tested and commercialized products with superior efficacy for various fungal indications, developed using its breakthrough technology platform Molecular Replacement Therapy (MRT).



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