Bausch Health's brain dysfunction treatment fails late-stage trials

Jan 23 (Reuters) - Bausch Health BHC.TO said on Friday its experimental treatment failed to prevent the first clinically visible symptoms of a neurological condition in patients with a type of liver disease, missing the main goal of two late-stage studies.

The studies were testing a new version of the company's antibiotic rifaximin, which is approved in the United States to reduce the risk of hepatic encephalopathy (HE), a condition where the liver can not remove toxins from the blood, allowing them to build up and impair brain function.

The two late-stage trials, involving more than 1,000 patients, evaluated rifaximin SSD for the delay of the first episode of HE in adults with liver cirrhosis who had no prior HE episodes.

"We are disappointed in the results, as there is currently no approved treatment for these patients," CEO Thomas Appio said, adding that the company is reviewing the data for other potential development opportunities.

U.S.-listed shares of the company BHC.N fell 8% in morning trading.

Hepatic encephalopathy is very common in advanced liver disease, especially cirrhosis, affecting up to 50% of patients, according to U.S. government data.

Sales of rifaximin, branded as Xifaxan in the U.S., reached $1.99 billion in 2024, accounting for about 20% of Bausch's total revenue.

The company has been fighting to protect Xifaxan from cheaper copies, with a U.S. appeals court upholding a ruling in 2024 that bars a proposed Alvogen generic until 2029. Bausch said it had reached settlement deals that would allow some generics to enter in 2028.

It is also working to complete a long-planned separation of its Bausch + Lomb eye-health business, a process currently stalled after earlier efforts failed to produce a deal.