Intercept's NASH drug fails late-stage trial, shares tumble

[October 01, 2022] 

By Khushi Mandowara

(Reuters) -Intercept Pharmaceuticals Inc said on Friday its treatment for patients with advanced liver scarring due to non-alcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study, sending its shares down as much as 21%.

Non-alcoholic steatohepatitis is a serious progressive liver disease that is one of the fastest-growing causes of liver transplant and does not have any FDA-approved treatments.

It causes fibrosis, an earlier stage of scarring that leads to the buildup of scar tissue, cirrhosis in its advanced stages and serious liver diseases such as cancer.

Several companies such as Madrigal Pharmaceuticals are racing to develop a NASH drug. Intercept has been hoping to file for approval of the drug obeticholic acid, in NASH patients with less advanced liver scarring.

Despite Friday's failure, Intercept said its plan to file for approval of the drug for treating fibrosis with NASH were still on track for the end of the year.

The U.S. Food and Drug Administration had earlier declined to approve the drug on uncertainty over whether benefits of treatment outweigh its risk.

Intercept said in July interim data from a new study showed the drug helped reduce fibrosis in patients with NASH compared to the placebo, but some analysts had expressed concerns over its efficacy. (https://reut.rs/3CmSfh9)

"Expectations were low, but this is consistent with our view the effect of the drug is modest," said Jefferies analyst Michael Yee.

In the current study, obeticholic acid, when compared to placebo, was not statistically significant in improving fibrosis, with no worsening of NASH.

Shares of New Jersey-based Intercept were down at $13.78 in morning trading.

(Reporting by Khushi Mandowara in Bengaluru; Editing by Arun Koyyur)

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