Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease with limited treatment options that can progress to more severe forms of liver damage such as cirrhosis or hepatocellular carcinoma. Targeting peroxisome proliferator-activated receptors (PPARs) with compounds such as elafibranor (GFT-505) is a feasible strategy for the prevention and treatment of NASH.
Celloram Inc. has signed a licensing agreement with Genfit SA to advance Celloram’s first-in-class inflammasome inhibitor, CLM-022. The agreement grants Genfit exclusive global rights to develop CLM-022 in liver disease indications.
Sequana Medical NV has reported additional data on safety, survival and quality of life from its POSEIDON pivotal study in North America, evaluating its Alfapump device used in the treatment of patients with recurrent or refractory ascites caused by liver cirrhosis. The data were recently presented at the European Association for the Study of the Liver 2023 congress in Vienna.
Researchers from Inipharm Inc. presented preclinical data for INI-822, a small-molecule inhibitor of HSD17B13, being developed for the treatment of liver disease.
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
Echosens SA obtained clearance from the U.S. FDA to expand the indications for screening with its Fibroscan system. The approval removes contraindications for pregnancy and active implant and includes patients with confirmed or suspected liver disease. It designates Fibroscan as a noninvasive aid for clinical management, diagnosis and monitoring of adult and pediatric patients with liver diseases. The age has been removed as the first selection probe and exam-type step.
Mirum Pharmaceuticals Inc. plans to “move rapidly toward regulatory filings” to expand use of IBAT inhibitor Livmarli (maralixibat) into progressive familial intrahepatic cholestasis (PFIC), President and CEO Chris Peetz told investors during a conference call Oct. 24 to discuss the positive top-line results from the phase III March study, which not only hit its primary endpoint in patients with PFIC2 but showed statistical improvements in pruritis across a range of PFIC subtypes.
