Viking Therapeutics’ nonalcoholic steatohepatitis candidate VK2809 significantly improved secondary histologic endpoints at 52 weeks with no worsening of fibrosis, as assessed by hepatic biopsy.
Tag Archive for: NASH
The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
In a collaboration agreement announced today, Boehringer Ingelheim will gain access to Ribo’s platform to target hepatocytes with investigational siRNA therapies for non-alcoholic steatohepatitis.
Once a hot target for investors, the non-alcoholic steatohepatitis space has hit a succession of snags this year—so many that some analysts believe big pharma is no longer interested in taking the risk. This could make getting the first targeted therapies to the market tricky, but experts say the adjacent weight loss space offers a compelling opportunity.
Akero Therapeutics said on Tuesday its lead drug missed the main goal in a mid-stage trial treatment of patients with a severe type of fatty liver disease, sending its shares tumbling 63% in premarket trading.
With Intercept’s failure to emerge as the non-alcoholic steatohepatitis market leader, Madrigal Pharmaceuticals is seeking to take leadership of the space fueled by a half-a-billion-dollar public offering.
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
The drug, efruxifermin, also met secondary efficacy goals when tested alongside a diabetes treatment belonging to a class of drugs known as GLP-1 receptor agonists in the trial.
Shares of Intercept Pharmaceuticals fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.