PARIS – Biopsy data from a subgroup of patients enrolled in Intercept Pharmaceuticals Inc.'s phase III POISE study of Ocaliva (obeticholic acid, or OCA) for the treatment of primary biliary cirrhosis (PBC) confirmed stabilization or regression of fibrosis/cirrhosis in 85 percent of the cohort following three years of treatment. The findings provided the first evidence that improvements in biochemical markers of PBC observed in previous studies are accompanied by antifibrotic effects suggested in preclinical trials of Ocaliva, which gained accelerated approval in 2016 to treat individuals with PBC who had an incomplete response to ursodeoxycholic acid (UDCA).
PARIS – Assembly Biosciences Inc. presented much-anticipated interim results Thursday from the phase Ia and ongoing phase Ib study of ABI-H0731, an antiviral directed at chronic hepatitis B virus (HBV) infection, in a late-breaking poster at the International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL).
PARIS – Clinicians were the target audience during the first day of presentations at the International Liver Congress (ILC), hosted by the European Association for the Study of the Liver (EASL). On Wednesday morning, EASL interactive research think tanks – a new format at this year's ILC – examined emerging studies in eight areas of importance to treating physicians. Topics ranged from identification of targets and pharmacotherapy in nonalcoholic steatohepatitis (NASH) to options and trends in managing advanced hepatocellular carcinoma (HCC), new directions in treating liver disease and the integration of care for HCV infection and substance use among people who use drugs.
PARIS – Clinicians were the target audience during the first day of presentations at the International Liver Congress (ILC), hosted by the European Association for the Study of the Liver (EASL). On Wednesday morning, EASL interactive research think tanks – a new format at this year's ILC – examined emerging studies in eight areas of importance to treating physicians. Topics ranged from identification of targets and pharmacotherapy in nonalcoholic steatohepatitis (NASH) to options and trends in managing advanced hepatocellular carcinoma (HCC), new directions in treating liver disease and the integration of care for HCV infection and substance use among people who use drugs.
The global scourge that is Alzheimer's disease (AD) claimed another biopharma victim as azeliragon (formerly TTP-488), the orally active small-molecule antagonist of receptor for advanced glycation end products, or RAGE, from Vtv Therapeutics Inc., crashed and burned in part A of the phase III STEADFAST study.
In three sentences, Incyte Corp. and Merck & Co. Inc. threw the immuno-oncology (I-O) world into a tailspin, revealing that the pivotal phase III ECHO-301/KEYNOTE-252 study evaluating Incyte's epacadostat in combination with Merck's Keytruda (pembrolizumab) in individuals with unresectable or metastatic melanoma failed a review by the external data monitoring committee (DMC).
Following Wednesday's market close, Steven Mento, president, CEO and co-founder of Conatus Pharmaceuticals Inc., carefully walked analysts and investors through the rationale, design and opportunities to learn from the phase IIb POLT-HCV-SVR trial of individuals with post-transplant fibrosis and cirrhosis – a group, he emphasized on the conference call, that's not been studied previously.
Call it the 150-day wonder. The formation of Allogene Therapeutics, which took off with a $300 million series A financing and a portfolio of assets from Pfizer Inc. related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, began with a conversation at a dinner on Nov. 3, 2017, celebrating the close of another big deal: the acquisition of autologous CAR T therapy player Kite Pharma Inc. by Gilead Sciences Inc.
Compugen Ltd. moved toward the next iteration of its transition from discovery engine to integrated development organization and showed some dealmaking might by giving Astrazeneca plc's Medimmune unit an exclusive license to develop bispecific and multispecific immuno-oncology (I-O) antibody products. The deal provides the Holon, Israel-based company with $10 million up front and up to $200 million in development, regulatory and commercial milestones for a first product as well as tiered royalties on sales.
Analysts quickly weighed in on abstracts from the International Liver Congress (ILC) 2018, set for next month in Paris, disclosed early Wednesday by the European Association for the Study of the Liver (EASL).