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news.Myriad Genetics has submitted an investigational new drug application to the FDA to begin human clinical trials with its drug candidate, Vivecon for the treatment of AIDS.
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Vivecon is a novel, small-molecule drug candidate that Myriad has designed to be taken orally and to inhibit viral maturation. Vivecon has been tested extensively for anti-viral activity and safety with both in-vitro and in-vivo models, in preclinical studies. It demonstrated anti-viral activity of less than 10 nanomolar IC50 against the HIV virus, with at least a 1,000-fold therapeutic safety index.
Vivecon has also shown a well-tolerated safety profile in a variety of preclinical studies. The first Phase I trial is intended to assess the pharmacokinetics, absorption and tolerability of the compound. This trial is formatted as a single-ascending dose in healthy volunteers.
Adrian Hobden, president of Myriad Pharmaceuticals, said: “Vivecon is an important addition to our pipeline of drug candidates in development to treat some of the most serious, costly and devastating diseases of our time.”