Resmetirom scores well in Ph III NASH and liver fibrosis trial

Shares of Pennsylvania, USA-based liver disease specialist Madrigal Pharmaceuticals (Nasdaq: MDGL) skyrocketed 270% to $227.90 after reporting success in non-alcoholic steatohepatitis (NASH), a therapy sector that so far has been littered with disappointments.

Madrigal announced positive top-line results from the pivotal Phase III MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. MAESTRO-NASH, a registrational Phase III trial, has achieved both liver histological improvement endpoints that the US Food and Drug Administration (FDA) proposed as reasonably likely to predict clinical benefit to support accelerated approval for the treatment NASH with liver fibrosis.

NASH is an area of very significant unmet medical need, with analysts forecasting revenue potential of up to $20 billion in the USA and Europe, should current pipeline efforts come to fruition.