NGM Bio’s NASH drug fails phase 2; focus shifts to programs in partnership with Merck

An experimental NGM Biopharmaceuticals treatment for non-alcoholic steatohepatitis, fatty liver disease more commonly known as NASH, has lack in clinical trials, a surprising result given that an earlier mid-stage study showed statistically significant improvement in the patient on several measures of disease.

In view of the failed clinical trial, NGM said on Monday that resources that had been set aside for the late-stage development of the NASH drug, aldafermine, will now be applied to other drug candidates discovered internally in its pipeline, including mid-stage drug candidates for eye disease and cancer.

NASH is a fatty liver disease that causes scarring that damages the organ and can get worse to the point of requiring an organ transplant. The prevalence of the disease increases due to fatty and sugary diets. The lack of any FDA-approved therapy for NASH is prompting a growing number of companies to develop one. But over the past year, several biotechs have stumbled into clinical trials, and a company’s application for its drug NASH has been rejected by the FDA.

NGM Bio’s drug, aldafermine, is a technical version of Fibroblast Growth Factor 19 (FGF19), a human hormone that plays a role in bile acid control and also has an effect on lipid metabolism. and glucose. Last August, during the digital meeting of the International Liver Congress, NGM Bio presented data from phase 2 showing that his drug led to statistically significant results in fibrosis, or scarring of the liver, as well as resolution of the disease.

NGM Bio had continued its evaluation of aldafermine in a phase 2b study which enrolled 171 NASH patients with hepatic fibrosis. These patients were randomly assigned to receive one of three doses of the study drug or a placebo. The severity of NASH is measured on a scale from stage 1, which is the lowest severity, to stage 4, which is characterized by excessive fibrosis and loss of liver function. The main objective of the phase 2b study was to show improvement in liver fibrosis by more than one stage without worsening disease after 24 weeks.

Although they did not meet the primary goal of the Phase 2b study, NGM Bio executives noted that aldafermine achieved statistically significant results on secondary endpoints, including resolution of NASH. , which was observed at the highest of the three doses tested. The medium and high doses also achieved secondary goals assessing the reduction in liver fat content.

Nonetheless, aldafermin’s inability to meet the primary goal of the clinical trial’s primary goal means that the drug is now joining others left out of the development of NASH. Others include a small molecule developed as part of a partnership between Novo Nordisk and Gilead Sciences which in 2019, lack to improve fibrosis in a phase 3 study. The R&D alliance continues with clinical trials of other drugs, alone and in various combinations.

Last May, Genfit reported that its drug elafibrinor failed to beat a placebo in an advanced NASH test. The failure triggered a corporate restructuring which shifted the focus of the France-based company to another liver disorder. Genfit’s drug failure was followed by the FDA rejection of obeticholic acid, a NASH drug candidate from Intercept Pharmaceuticals.

While NGM Bio focuses on aldafermine, its only wholly-owned program, the company’s most advanced programs are NGM621, an antibody drug candidate for geographic atrophy of eye disorders, and NGM120, a potential treatment for it. metastatic pancreatic cancer and cachexia, which is the weight loss and wasting caused by cancer. Both drugs are in phase 2 testing and are covered by a partnership with Merck, according to a investor presentation.

The Merck alliance, which began in 2015, gives NGM Bio the ability to determine scientific direction and areas of therapeutic interest with input from the pharmaceutical giant. NGM Bio is responsible for preclinical and clinical development up to proof-of-concept studies in humans. Merck prepaid $ 94 million to NGM Bio and made an equity investment valued at around $ 106 million.

Merck, based in Kenilworth, New Jersey, is also contributing cash to its partner’s R&D. Until the end of 2020, the pharmaceutical giant paid NGM Bio $ 495.8 million as part of the collaboration, according to the biotech. Annual report 2020. If Merck licenses collaborative programs, it must pay $ 20 million for each.

According to NGM Bio’s first quarter financial report, the company had total assets of $ 425 million at the end of March, including $ 148.1 million in cash and cash equivalents.

Public domain image by Flickr user NIH Image Gallery

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