Idorsia Initiates P-III (FAB-KLEAR) Trial of Lucerastat for Fabry Disease and Partners with Nxera for Japan and APAC

Shots: Idorsia has initiated the pivotal P-III (FAB-KLEAR) kidney biopsy trial of lucerastat, an oral substrate reduction therapy, in 16 treatment-naïve or pseudo-naïve adult male pts with Fabry disease, assessing change in kidney Gb3 BLISS score at Mos. 18 as its 1EP The P-III program also includes the 74-pt FAB-SWITCH trial vs SoC ERTs; both trials are expected to support a regulatory filing as early as 2029 under an FDA-aligned strategy Separately, Nxera Pharma exercised its option to gain exclusive rights to lucerastat in Japan & selected APAC markets (ex-China), paying CHF 7M upfront & contributing to the global P-III program, while Idorsia remains eligible for royalties Ref: GlobeNewswire  |   Image: Idorsia & Nxera Pharma  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Idorsia Initiates P-III (FAB-KLEAR) Trial of Lucerastat for Fabry Disease and Partners with Nxera for Japan and APAC appeared first on PharmaShots.