Merck’s efinopegdutide shows promise in nonalcoholic fatty liver disease
14 Jun 2023
Phase 2License out/inDrug ApprovalFast Track
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Source: PMLiVE
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonistGLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD).
NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD.
There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition.
The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound's efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients.
The candidate was recently granted fast track designation from the US Food and Drug Administration (FDA) as a potential treatment for patients with nonalcoholic steatohepatitis (NASH), a more severe form of NAFLD that includes inflammation and damage to the liver.
Efinopegdutide will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate the review of drugs to treat serious conditions and fill an unmet medical need.
Sam Engel, associate vice president, global clinical development, Merck Research Laboratories, said: “Significant patient need remains for new treatment options for NASH. This compelling data in patients with NAFLD, along with the recent receipt of fast track designation from the FDA, provides strong rationale for advancing efinopegdutide into phase 2b development for patients with NASH.”
Merck entered into a licensing agreement with Hanmi Pharmaceutical in 2020 for the licensing rights to efinopegdutide.
The latest announcement regarding the compound comes just over a week after the Merck’s Prevymis (letermovir) was approved in the US to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients.
The company and AstraZeneca’s Lynparza (olaparib) was also granted approval by the FDA this month as a treatment option for metastatic castration-resistant prostate cancer (mCRPC).
Specifically, the PARP inhibitorPARP inhibitor is now authorised in combination with Johnson & Johnson's anti-androgen therapy Zytiga (abiraterone) and a corticosteroid to treat patients with mCRPC whose tumours have BRCA mutations.
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