PRINCETON, N.J., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Vyome Therapeutics, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, today announced the completion of enrollment of 471 subjects in its Phase 2 clinical trial of VB-1953, a first-in-class topical bactericidal antibiotic, for the treatment of moderate to severe inflammatory acne.
The Phase 2 dose ranging trial (NCT03900676), initiated in April of 2019, is a double-blind, randomized, vehicle controlled, dose ranging study evaluating the safety and efficacy of VB-1953 topical gel when applied once versus twice daily for twelve weeks in subjects with moderate to severe inflammatory facial acne vulgaris.
"We are pleased to have completed enrollment in our Phase 2 dose ranging clinical trial of our promising topical therapeutic candidate for the treatment of moderate to severe inflammatory acne" said Venkat Nelabhotla, president & chief executive officer of Vyome Therapeutics. "VB-1953 represents not only an innovative and promising approach to tackling the growing problem of antibacterial resistance in this dermatological condition, but a potentially effective anti-inflammatory solution to reducing inflammatory lesions in C. acnes and we look forward to reporting data from this Phase 2 trial in the first quarter of 2020."
"There are currently 10 million Americans suffering from antibiotic resistant and inflammatory acne, whose only effective treatment options are oral systemic drugs, commonly associated with a risk of side effects that are often severe." said Dr. Angelo Secci, chief medical officer of Vyome Therapeutics. "We believe that VB-1953 has the potential to significantly change the treatment paradigm for this large and increasing patient population by providing an effective topical acne treatment, allowing resistant patients to stay off of systemic drugs."
Vyome’s lead molecule, VB-1953, is a first-in-class & novel topical bactericidal clinical drug candidate with a novel mechanism of action that includes inflammation-reducing capabilities through immune-modulatory effect as well as the demonstrated ability to treat antibiotic resistant C. acnes strains. VB-1953 is currently being studied in a Phase 2 dose ranging clinical trial in the United States. In preclinical studies, VB-1953 showed activity against clindamycin-resistant P. acnes bacteria, a low emergence of resistance and the ability to reduce inflammation. VB-1953 is delivered with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. Acne caused by antibacterial-resistant C.acnes currently poses an emerging and unmet need for patients worldwide, with a potential $2B market opportunity in the US alone.
About Vyome Therapeutics
Vyome Therapeutics is a clinical stage specialty pharmaceutical company based in Princeton, New Jersey, developing a deep pipeline of drugs for the treatment of drug-resistant skin pathogens & inflammatory conditions, including for inflammatory acne. Vyome recently closed a $22 million fund raise in January 2019 from new and existing investors, including Perceptive Advisors, Romulus and Iron Pillar. Vyome advanced its lead clinical candidate, VB-1953, into a Phase 2 clinical trial for the treatment of moderate to severe inflammatory acne.
Vyome has a deep pipeline of preclinical new chemical entities, based on its patented Dual Action Rational Therapeutics (DARTs) technology, which are unique in their ability to overcome antimicrobial resistance and work on inflammatory conditions . Vyome has developed clinically validated antifungal products based on its innovative and patented technology platform Molecular Replacement Therapeutics (MRT™), a platform for which Vyome has recently signed an out-licensing deal of marketing rights with a large specialty pharmaceutical company. More information is available at http://www.vyometx.com and @VyomeTx.
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