The FDA turned down an Intercept Prescribed drugs drug software for the fatty liver illness NASH, a choice that comes practically three years after the regulator first rejected the molecule. The company remains to be asking for extra information, however this time the corporate gained’t strive once more. Intercept introduced a company restructuring late Thursday that may refocus its efforts on different liver illnesses.
Intercept was as soon as thought of a frontrunner within the race to develop and commercialize the primary drug for non-alcoholic steatohepatitis, or NASH, a illness that results in irritation and scarring within the liver. The illness, which might in the end result in liver failure, has been rising in prevalence. Morristown, New Jersey-based Intercept aimed to deal with the dysfunction with obeticholic acid, an analog of a bile acid present in people. The drug is designed to bind to a receptor within the liver and the intestines that regulates pathways governing irritation, fibrosis, and metabolism.
The FDA accepted obeticholic acid in 2016 for treating main biliary cholangitis, a uncommon illness of the bile ducts. For that indication, Intercept markets the once-daily tablet beneath the model identify Ocaliva. It accounted for $285.7 million in 2022 income, in response to Intercept monetary stories. However the firm hoped the drug’s mechanism of motion would additionally work for NASH and it ran scientific trials in that indication utilizing a distinct dose.
In 2020, the FDA rejected the Intercept’s software looking for accelerated approval in NASH and known as for extra information. The company didn’t ask the corporate to run one other scientific trial. As a substitute, the FDA stated it wanted to see extra information from the continued Section 3 research. Intercept went on to provide extra information, reaching outcomes it felt supported a resubmission of a brand new drug software. As issues turned out, the trail has not been smoother the second time round.
Final month, an FDA advisory voted that based mostly on the accessible information, obeticholic acid’s advantages don’t outweigh its dangers. The committee additionally voted that an FDA determination on accelerated approval of the drug ought to wait till end result information from the continued Section 3 research are submitted and reviewed. The FDA in the end agreed. In accordance with Intercept, the FDA’s letter to the corporate requested for, at minimal, profitable completion of the long-term outcomes section of the Section 3 research.
Whereas Intercept has been attempting to carry obeticolic acid throughout the regulatory end line, rival NASH drug builders have had time to catch up. Madrigal Prescribed drugs is making ready an FDA submission for resmetirom, a small molecule that works differently than Intercept’s drug. Viking Therapeutics has reported optimistic mid-stage information for its NASH drug candidate. Others gaining floor within the NASH drug race embody Akero Therapeutics and 89bio.
Intercept stated its restructuring will minimize headcount by about one third. On the finish of 2022, Intercept reported having 341 staff. Restructuring prices are estimated to be about $16 million, in response to a securities submitting. With the company shake-up, Intercept tasks it should obtain profitability in 2024.
“We consider that taking decisive motion to reshape Intercept will enhance our long-term potential to develop our enterprise, innovate for sufferers, and create worth for shareholders,” Intercept President and CEO Jerry Durso stated in a ready assertion. “We stay dedicated to the liver neighborhood and can proceed to advance our management in uncommon and critical liver illnesses the place Intercept has deep experience and a acknowledged dedication to therapeutic innovation.”
Going ahead, Intercept will nonetheless have Ocaliva, which inserts inside its uncommon liver illnesses technique. The corporate has additionally reached Section 2 testing of that drug and bezafibrate in main biliary cholangitis. One other program, INT-787, has reached Section 2a testing for extreme alcohol-associated hepatitis. The compound works differently than Ocaliva, binding to and activating a receptor known as FXR. The corporate has stated that in preclinical analysis, this strategy has proven anti-fibrotic and anti inflammatory results.
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