Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022.
Preliminary Phase 2 results show 83% of those treated with Boehringer Ingelheim and Zealand Pharma drug survodutide met the main goal of improvement in the fatty liver disease MASH. Boehringer contends this drug has best-in-class potential in a competitive field that includes an Eli Lilly drug that recently posted positive Phase 2 results.
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Non-invasive liver tests provide an accessible means for healthcare providers to monitor the positive effects of patient lifestyle changes over time, reinforcing the positive behaviors that lead to improved liver health – halting or even reversing the progression of liver disease
A Madrigal Pharmaceuticals drug for the fatty liver disease NASH has data from a pivotal clinical trial showing improvements in the organ. Based on those results, which sent Madrigal's stock price soaring more than 200%, the biotech is planning to seek what could become the first regulatory approval of a therapy for this metabolic disorder.
Akero Therapeutics’ experimental NASH drug, efruxifermin, met the main and secondary goals of Phase 2b clinical trial. The biotech will still need to show that the drug’s efficacy can hold up in a pivotal study, but the results so far are a positive sign for the NASH field, which has been marred by clinical trial failures.
GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for rights to the experimental therapy. The Arrowhead drug uses RNA interference to “silence” an enzyme associated with the progression of the fatty liver disease.
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The FDA has requested additional data from the company's clinical trial. Intercept's CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.
The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.
The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept's obeticholic acid.
In a note to investors, an analyst wrote that the news bodes well for the company's anticipated Phase III readout for the drug, elafibranor. Another company, Intercept Pharmaceuticals, said the FDA had accepted its application for its investigational NASH drug, obeticholic acid.
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The deal comes days after Gilead partnered on clinical development in NASH with Denmark's Novo Nordisk, and two months after the high-profile failure of a Phase III study in the disease.
The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.
Shares of the New York-based company jumped nearly 20 percent Tuesday on news that the REGENERATE study of obeticholic acid showed strong improvement in NASH-related liver fibrosis.
The company said a Phase III study of selonsertib had failed, sending shares down 4 percent and feeding analyst pessimism on another Phase III study of the drug in patients with less advanced disease.
A new report by GlobalData has underscored the extreme blockbuster potential of fatty liver disease and non-alcoholic steatohepatitis (NASH), projecting that the current $618 million market will balloon to $25.3 billion by 2026.