SFA Therapeutics Inc. has received FDA clearance of its IND application to investigate SFA-001N in patients with nonalcoholic steatohepatitis (NASH) with or without fibrosis.
Obesity and chronic inflammation in the liver trigger the most severe form of nonalcoholic fatty liver disease (NAFLD), steatohepatitis. Scientists at the University of Texas (UT) have shown how damaged hepatocytes accumulated in the liver after a vicious cycle of cytokine expression induced shedding of a critical liver receptor.
“Far superior to what almost anyone expected,” was how H.C. Wainwright analyst Ed Arce described the top-line readout for Madrigal Pharmaceuticals Inc.’s phase III study of resmetirom, which hit both of its dual endpoints in patients with nonalcoholic steatohepatitis (NASH) and is expected to form the basis of an accelerated approval application to the U.S. FDA in the first half of 2023.
Farnesoid X receptor (FXR) has been previously identified as an important drug target for nonalcoholic steatohepatitis (NASH) and other related diseases, with GW-4064 being the first nonsteroidal FXR agonist used to explore the biological functions of FXR. Scientists at KBP Biosciences Co. Ltd. and Shandong University designed a novel series of FXR agonists as potential candidates for the treatment of NASH.
Olix Pharmaceuticals Inc. has obtained promising data with OLX-702-A, an investigational GalNAc-asiRNA therapeutic for the treatment of nonalcoholic steatohepatitis (NASH), in a nonhuman primate NASH model. Administration of OLX-702-A resulted in a significant reduction in liver fat content, measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Altimmune Inc. has come under scrutiny from investors after weight loss data from a phase Ib trial of its nonalcoholic fatty liver disease drug, pemvidutide, sent its shares on a roller coaster ride.
Shares in Akero Therapeutics Inc. more than doubled in value after the company announced results from a phase IIb nonalcoholic steatohepatitis trial that it believes show lead candidate efruxifermin could challenge other candidates in development for the fatty liver disease targeted by so many biotechs and big pharmas.
China's National Medical Products Administration (NMPA) has cleared CSPC Pharmaceutical Group Limited to conduct clinical trials of TG-103 injection for the treatment of Alzheimer's disease and for the treatment of nonalcoholic steatohepatitis (NASH).
