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Phase III Data In Suspected NASH Boost Madrigal’s Profile, But Bigger Data To Come

 
• By Joseph Haas

Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.

Madrigal office
Madrigal unveils additional data de-risking NASH candidate resmetirom • Source: Madrigal

Madrigal Pharmaceuticals, Inc. continued the process of de-risking Phase III non-alcoholic steatohepatitis (NASH) candidate resmetirom on 31 January, releasing positive top-line data from the Phase III MAESTRO-NAFLD-1 study in suspected NASH patients, a precursor to the biopsy-driven pivotal Phase III MAESTRO-NASH study, which is expected to report data in the third quarter of 2022.

The MAESTRO-NAFLD-1 results showed the drug’s safety and tolerability and suggested hepatic fat-reducing and LDL cholesterol-lowering capabilities on secondary endpoints.

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GSK’s Nucala Set For Dupixent Face-Off After FDA COPD Nod

 
• By Kevin Grogan

The UK major's asthma drug gets a key expanded approval.

Merus Bispecific Impresses In Head And Neck Cancer

 
• By Andrew McConaghie

Updated Phase II results from petosemtamab have impressed ahead of ASCO, outshining Keytruda monotherapy and its bispecific rival from Bicara.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By Kevin Grogan

The French drugmaker is expanding its neurology activities with the $470m deal.

More from R&D

Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
• By Kevin Grogan

The French drugmaker is expanding its neurology activities with the $470m deal.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By Joseph Haas

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Merck KGaA Plans Phase III For Enpatoran After Mixed Phase II Lupus Data

 
• By Jessica Merrill

The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.