TMS Co., Ltd. announced that the first subject was dosed on June 19 in the Phase I clinical trial (Phase I single-dose, dose escalation study of TMS-008 in healthy adult male subjects; the Study) of TMS-008, which is being developed as a potential treatment for acute kidney injury. The results of previous non-clinical studies have confirmed the efficacy and safety of TMS-008 in the non-clinical phase of the study. In this Study, TMS-008 will be administered to healthy adult male subjects in escalating doses to confirm safety, tolerability, and pharmacokinetics in humans.

The study will be conducted at the University of Tokyo Hospital. All subjects will be administered and observed by the end of this fiscal year, and the first readout is scheduled in the first quarter of fiscal year 2025. TMS-008 is a compound of SMTP (Stachybotrys microspora triprenyl phenol) family compounds derived from a type of black mold.

The compound has strong anti-inflammatory and antioxidant activity by inhibiting soluble epoxide hydrolase (sEH) and is expected to have potential as a treatment for acute kidney injury.