Boehringer Ingelheim ends BI 1467335 development for NASH

Boehringer Ingelheim has discontinued BI 1467335 development for non-alcoholic steatohepatitis (NASH) treatment after reviewing results from a Phase I clinical trial.

BI 1467335 is an anti-inflammatory amine oxidase copper-containing 3 (AOC3) inhibitor being developed to treat NASH and diabetic retinopathy. Boehringer acquired the drug in 2015 from Australia-based Pharmaxis.

BI 1467335 was well tolerated and without any serious adverse events in a multi-centre, double-blind, 114-patient Phase IIa trial.

The study also achieved the pre-specified targets for AOC3 activity inhibition, compared to placebo, along with clinically relevant changes in NASH biomarkers.

This Phase IIa trial aimed to determine the proof-of-clinical principle, assess suitable dosing, and establish the safety of the drug candidate.

Boehringer said that the decision to end the development for NASH was based on a recent Phase I trial, which indicated a risk of drug interactions.

Pharmaxis CEO Gary Phillips said: “We are disappointed that BI 1467335 is not advancing in NASH. We look forward to further scientific discussion when the full data and analysis from this Phase IIa clinical trial and Boehringer Ingelheim’s recently reported Phase I study are available for review.”

Boehringer noted that other studies of BI 1467335, including a Phase IIa trial in diabetic retinopathy patients, will continue unchanged.

The Phase IIa diabetic retinopathy study has closed patient enrolment and results are expected to be available in the second half of next year.

Boehringer will continue to develop other therapies for the treatment of NASH, which is a key cause of liver fibrosis and cirrhosis.

In October, the company started recruiting patients in the Phase II BALANCE-CF trial of BI 1265162, an epithelial sodium channel (ENaC) inhibitor, to treat cystic fibrosis.