Presidio Pharmaceuticals, Inc. announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the initiation of a Phase 1 first-in-human clinical trial of PPI-461, an orally administered NS5A inhibitor for the treatment of hepatitis C virus (HCV). The Phase 1 clinical trial will be conducted in healthy volunteers.
“We are pleased to advance PPI-461 into clinical development to evaluate its safety, tolerability and pharmacokinetic profile in healthy volunteers”
"We are pleased to advance PPI-461 into clinical development to evaluate its safety, tolerability and pharmacokinetic profile in healthy volunteers," stated Nathaniel Brown, M.D., Chief Medical Officer at Presidio.
At the recent European Association for the Study of the Liver (EASL) conference, Presidio's Richard Colonno, Ph.D., Chief Scientific Officer, said, "PPI-461 exhibited potent and selective activity against all HCV genotypes in the in vitro replicon system, showed good oral bioavailability in multiple animal species and was well tolerated in a variety of animal studies. PPI-461 exhibited elevated liver concentrations relative to plasma levels that may be advantageous for lower dose regimens and a pharmacokinetic profile that indicated the potential for once daily dosing in humans."
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