Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter 2024.
Using interactions between viral peptides and human proteins as a starting point, researchers from Enyo Pharma Inc., the University of Lyon and other institutions were able to bootstrap themselves to a mitochondria-targeting small molecule that showed activity in a mouse model of nonalcoholic steatohepatitis (NASH) with chronic kidney disease.
Sagimet Biosciences Inc. stock (NASDAQ:SGMT) more than doubled Jan. 22 as shares closed 170% higher at $18.42 each as a phase IIb study of lead candidate denifanstat performed well against nonalcoholic steatohepatitis (NASH) compared to placebo. Top-line data from the 52-week, randomized, double-blind Fascinate-2 trial showed the oral fatty acid synthase inhibitor resulted in statistically significant improvements in biopsy-confirmed NASH patients with stage 2 or stage 3 fibrosis, which is moderate to severe disease, at week 52.
Boehringer Ingelheim GmbH’s start to the new year includes two fresh deals across two continents. BI struck one deal with Kunshan, China-based Suzhou Ribo Life Science Co. Ltd. and its Mölndal, Sweden-based subsidiary, Ribocure Pharmaceuticals AB, to develop small interfering RNA (siRNA) treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis. It struck a second deal with San Francisco-based 3T Biosciences Inc. to develop cancer immunotherapies, which builds on an earlier collaboration formed last year. Combined, the two deals are worth more than $2.5 billion.
Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies.
Boehringer Ingelheim Pharma GmbH & Co. KG has identified 17-β-hydroxysteroid dehydrogenase 13 (HSD17B13; 17-β-HSD 13) inhibitors reported to be useful for the treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).