We may be nearing the first-ever approval for a nonalcoholic steatohepatitis (NASH) drug next year, but the road to approval is not getting easier.
Just ask German pharma Boehringer Ingelheim and partner Pharmaxis, which today have dumped their effort to treat fatty liver disease when the midstage drug, an SSAO/VAP-1 inhibitor known as BI 1467335, didn’t so much fail directly but was canned due to interactions with other meds.
Boehringer spent $250 million on Sydney-based Pharmaxis' NASH drug back in 2015, when it was in phase 1, on the hopes that it could get in on a market potentially worth billions of dollars a year.
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Intercept and Genfit are currently the front-runners, vying for a first approval that could come next year, but both those companies and a host of others, including the likes of Gilead Sciences, have been beset by setbacks and failures in this area, with questions over marketability and diagnosis also still to be decided.
BI and Pharmaxis’ drug is designed to work by blocking leukocyte adhesion and tissue infiltration during inflammatory processes, an approach that differs from those taken by Intercept and Genfit.
But in this instance, while the drug met its “pre-specified targets for inhibition of plasma amine oxidase copper-containing 3 (AOC3) activity compared to placebo as well as clinically relevant changes in NASH biomarkers,” it will now be discontinued after a phase 1 test found it increased “the risk of drug interactions of the compound in NASH patients” the company couldn’t resolve.
The investigators did not specify which drug interactions, but many NASH patients would likely also be on a series of other meds for conditions such as diabetes and cardiovascular disease.
But while dead in the water for NASH, other tests are ongoing for BI 1467335, including a phase 2a study in diabetic retinopathy that has completed recruitment and is due to report in the second half of next year.
Pharmaxis' shares were nearly halved on the news.