Health AI Central
Peer-Reviewed Publication
Pharmacogenomics J2026;26(5)September 28, 2026Clinical Trial, Phase II

Risk of drug-induced liver injury in multiple system atrophy patients treated with KM-819 is potentially associated with the HLA-DPB1*05:01:01:01 allele.

Jeong-Hoon Han1, Raúl J Andrade2,3, Einar Stefán Björnsson4,5, James Hendricks Lewis6, M Isabel Lucena3,7, Suyoung Go1, Simona Stankeviciute8, Guruprasad P Aithal9, Kyuchan Kim1, Chong Sik Lee10, Carrolee Barlow1, Eunhee Kim11
1Kainos Medicine, Inc., Seongnam-si, Gyeonggi-do, Republic of Korea.
2Department of Medicine and Gastroenterology Service, IBIMA-Plataforma Bionand, Hospital Universitario Virgen de la Victoria, University of Málaga, Málaga, Spain.
3Centro de Investigación en Red en el Área Temática de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
4Department of Internal Medicine, Landspitali University Hospital, University of Iceland, Reykjavík, Iceland.
5Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
6Division of Gastroenterology, Department of Medicine, Georgetown University, Washington, D.C., USA.
7Servicio de Farmacología Clínica, IBIMA-Plataforma Bionand, Hospital Universitario Virgen de la Victoria, University of Málaga, Málaga, Spain.
8Regulatory Consulting, Parexel International, 2520 Meridian Parkway, Durham, NC, 27713, USA.
9NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, and the University of Nottingham, Nottingham, UK.
10Department of Neurology, CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, Republic of Korea.
11Kainos Medicine, Inc., Seongnam-si, Gyeonggi-do, Republic of Korea. eunhee@kainosmedicine.com.
PubMed DOI

Abstract

KM-819, a first-in-class inhibitor of Fas-associated factor 1 (FAF1), was investigated in a Phase 2 clinical trial in Korean patients with multiple system atrophy (MSA). Among 34 KM-819-treated patients, 11 met the case definition for suspected DILI, and 9 of these (26%) were adjudicated by an independent hepatic adjudication committee (HAC) as KM-819-related DILI; no cases occurred among the 34 p…

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