Antibe Therapeutics Inc. announced the completion of the pharmacokinetic/pharmacodynamic (?PK/PD?) study of otenaproxesul?s faster-absorbing formulation for acute pain. The study was designed to confirm the drug?s
safety and inform treatment regimens for the upcoming Phase II trial, on track to launch in calendar First Quarter 2024. The PK/PD study involved 36 healthy volunteers randomized across three treatment arms: a single high dose and two five-day regimens of otenaproxesul. The five-day regimens were chosen to correspond to regimens envisaged for the upcoming Phase II trial. Subjects remained in-clinic for the duration of their treatment. All subjects
completed the study with no clinically significant, drug-related adverse events and no elevation in liver enzymes during treatment or in post-treatment follow up.