89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.
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
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Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
The startup, which licensed three NASH candidates from Eli Lilly, raised $87 million from the drugmaker and Deerfield Management.
Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
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The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
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.
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Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. This marks the second delay of data since September and means it will likely be announced in the second quarter rather than the first.
These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.
In an interview at the BIO CEO & Investor Conference in New York Monday, CEO Pascal Prigent said barriers to access rather than reimbursement represent the biggest concern for NASH drugs like elafibranor. As a ballpark estimate, a list price in the $10,000 range is possible.
The German drugmaker announced a partnership with Enleofen to develop the company's suite of preclinical antibodies targeting IL-11 in diseases like NASH.
BI said it would continue to develop the drug, BI 1467335, in other diseases and remain committed to NASH overall. Shares of the Australian company from which it licensed the drug, Pharmaxis, fell more than 40%.