A new assay developed by Metadeq Inc. may be bringing the days of the invasive liver biopsy for non-malignant conditions to a close. The company’s liquid biopsy successfully used the presence of two proteins in blood to identify and stage non-alcoholic steatohepatitis (NASH) and liver fibrosis in a study published in Gut.
More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy.
New data confirming that Gilead Sciences Inc.’s Hepcludex (bulevirtide) effectively cures hepatitis delta virus (hepatitis D), one of the most severe viral infections of the liver, and favorable phase III results from Madrigal Pharmaceuticals Inc.’s nonalcoholic steatohepatitis (NASH) contender were among the highest-profile scientific announcements at the International Liver Congress (ILC) 2022.
Glympse Bio Inc.’s diagnostic platform has demonstrated the ability to detect hepatocellular carcinoma (HCC) in blood, offering a non-invasive method for diagnosing the disease much earlier and more reliably than current approaches. The platform uses biosensors and machine learning to measure protease activity in plasma samples. Details of studies demonstrating the system’s accuracy in HCC will be presented at the International Liver Conference 2022 in London.
Intent on expanding both the reach and approved uses of its farnesoid X receptor agonist, Ocaliva (obeticholic acid), Intercept Pharmaceuticals Inc. is selling both its ex-U.S. operations and rights to the primary biliary cholangitis drug to U.K.-based Advanz Pharma Corp. Ltd. for $405 million up front. The deal, including an additional $45 million earnout tied to EU regulatory advances, represents an important step toward strengthening Intercept's balance sheet and options, said CEO and President Jerry Durso.
With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
LONDON – Metabolic diseases specialist Northsea Therapeutics BV closed a $80 million series C to fund phase II development in two further indications, as it awaits the final results from the phase IIb trial of its lead product, icosabutate, in the treatment of nonalcoholic steatohepatitis (NASH), which are due at the start of 2023.
An international collaborative study led by Chinese researchers at Wuhan University is the first to have discovered a new small molecule, termed IMA-1, and shown it to be safe and effective for the treatment of nonalcoholic steatohepatitis (NASH) in mouse and macaque models.
Glaxosmithkline plc (GSK) tapped Arrowhead Pharmaceuticals Inc. for its foray into nonalcoholic steatohepatitis (NASH), as the pair signed an exclusive global licensing deal (excluding China) for GSK to develop and commercialize phase I/II-stage ARO-HSD, Arrowhead’s RNAi therapy targeting HSD17B13.
