ABBISKO-B (02256): HuYu Medicine will present the dose selection study results guided by the pirfenidone model at the 2024 ACoP conference.

ABBISKO-B (02256) announced that its subsidiary and honor medicine presented the results of dose selection studies for their orally administered, highly selective, active CSF-1R small molecule inhibitor, Peminternib (ABSK021), for the treatment of tenosynovial giant cell tumor (TGCT) at the 2024 American Conference on Pharmacometrics (2024 ACoP conference). The study integrated drug metabolism kinetics, safety, and efficacy information to guide model-guided dose selection. The results supported the recommendation of 50mg QD as the optimal dose for Peminternib for the global development and treatment of TGCT. Peminternib is an orally administered, highly active, highly selective CSF-1R small molecule inhibitor with minimal inhibitory effects on c-Kit and PDGFR. It is currently being developed for the treatment of TGCT patients, a rare locally aggressive tumor primarily caused by overexpression of the CSF-1 gene. The purpose of this analysis was to develop a population pharmacokinetic (popPK) model and identify intrinsic/extrinsic factors significantly influencing the PK behavior of Peminternib. Additionally, exposure-response analysis was conducted to describe the relationship between Peminternib exposure and efficacy/safety endpoints to support the selection of appropriate doses in subsequent clinical development in TGCT patients. The study characterized the population pharmacokinetics of Peminternib, exposure-response relationships, and their relationship with efficacy and safety. These models were used to determine the optimal dose selection for Peminternib, with the study results supporting the recommendation of 50mg QD as the optimal dose for the global development and treatment of TGCT.