Antibe Therapeutics Inc. announced the PK results of the pharmacokinetic/pharmacodynamic ("PK/PD") study of otenaproxesul's faster-absorbing formulation. The study was designed to confirm the drug's safety and inform the selection of 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 o tenaproxesul.

Subjects remained in-clinic for the duration of their treatment. As previously reported, all subjects completed the study with no clinically significant, drug-related adverse events and no increase in liver enzymes. In line with preclinical data and DILIsym liver safety modeling, the study confirmed the new formulation's linear, dose-proportional PK, with substantially lower doses needed to achieve target plasma levels compared to the original formulation.

More rapid elimination was also observed, expanding the drug's safety envelope. These data provide the basis for selecting treatment regimens to achieve the pain relief expectations of patients, doctors and regulators. They also advance Antibe's exploration of potential treatment regimens for chronic pain.