SAN FRANCISCO – A new online map of hepatitis C virus (HCV) screening, diagnosis and treatment data built by Abbvie Inc. is shedding added light on where the infection is most common in the U.S. and where gaps in treatment exist. HCV is the most common chronic infectious disease in the country, with an estimated 3.4 million people infected, the company said. It plans to update the data twice yearly.
SAN FRANCISCO – Surprising no one, progression to cirrhosis in patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) cirrhosis in the U.S. is associated with increased health care resource utilization (HCRU) and costs, a Bristol-Myers Squibb Co.-sponsored study has found. The analysis could provide critical ammunition for drug developers such as BMS seeking to deploy economic arguments for the role of pharmaceutical intervention in reducing the condition's contribution to the upward march of health care costs.
SAN FRANCISCO – New preliminary phase II data on a 1-mg dose of NGM-282 and existing data on a 3-mg dose of the nonalcoholic steatohepatitis (NASH) candidate, in development by NGM Biopharmaceuticals Inc., show "unprecedented antifibrotic activity" at week 12 of an open-label study, the study's principal investigator, Stephen Harrison said.
SAN FRANCISCO – Seal Rock Therapeutics Inc., a small West Coast company moving a preclinical candidate for nonalcoholic steatohepatitis (NASH) toward a 2020 clinical debut, poked its head above water for the first time during Friday's kickoff of the American Association for the Study of Liver Diseases. The startup, founded in late 2016 and led by several Takeda Pharmaceutical Co. Ltd. veterans, revealed an internally discovered inhibitor of apoptosis signal-regulating kinase 1 (ASK1) as its lead candidate.
Newark, Calif.-based Incarda Therapeutics Inc., a company developing an inhaled therapy for recent-onset paroxysmal atrial fibrillation (PAF), has closed a $42 million series B financing. Proceeds from the round will be used primarily to fund the company's recently initiated phase II study of Inrhythm, an inhaled flecainide drug-device combo. Results from the study will be available in the second half of 2019, Incarda's president and CEO, Grace Colón, told BioWorld.
Mirum Pharmaceuticals Inc., a San Diego-based startup picking up the unfinished work of Shire plc's 2014 buy, Lumena Pharmaceuticals Inc., has landed a $120 million series A led by New Enterprise Associates (NEA) to advance what it sees as a viable and well-validated therapy for a pair of rare liver diseases. Its team plans to advance the candidate, maralixibat, into phase III trials next year, targeting progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS).
Sanofi SA’s Genzyme Corp. has agreed to pay Denali Therapeutics Inc. $125 million to kickstart development of multiple small-molecule inhibitors of receptor-interacting serine/threonine-protein kinase 1 (RIPK1), a signaling protein that regulates inflammation and cell death in a variety of diseases. The candidates could potentially benefit people with Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Should all succeed, Denali could earn nearly $1.1 billion in milestone payments from Sanofi.
Shares of Clearside Biomedical Inc. (NASDAQ:CLSD) fell 62.8 percent to $2.07 Monday on news that combining its suspension of triamcinolone acetonide (TA) with Regeneron Pharmaceuticals Inc.'s Eylea (aflibercept) failed to help people with retinal vein occlusions (RVO) see any better than treatment with Eylea alone. The Alpharetta, Ga.-based company is discontinuing the RVO program to focus on an application of the same suprachoroidally administered drug as a monotherapy for treating uveitis-associated macular edema. Plans to submit a new drug application in that indication by year-end remain on track, said CEO and President Daniel White.
Adverum Biotechnologies Inc. is quitting development of a phase I/II gene therapy for alpha-1 antitrypsin deficiency (A1ATD) and abandoning plans to submit an investigational new drug application for another candidate employing the same capsid after the A1AT trial failed to show clinically meaningful protein expression. Company shares (NASDAQ:ADVM) fell $1.21, or 26.6 percent, to $3.34 on Friday.
