Boehringer Ingelheim dumps NASH drug program amid concerns over drug interactions

BI said it would continue to develop the drug, BI 1467335, in other diseases and remain committed to NASH overall. Shares of the Australian company from which it licensed the drug, Pharmaxis, fell more than 40%.

The race by drugmakers to develop drugs to treat a form of fatty liver disease that currently has no approved treatments just had its latest crash.

German drugmaker Boehringer Ingelheim and its development partner, Australian biotech company Pharmaxis, said Wednesday that they would discontinue development of the drug BI 1467335 in nonalcoholic steatohepatitis, also known as NASH. The drug, which BI acquired from Frenchs Forest, Australia-based Pharmaxis in 2015, was shown in a Phase IIa clinical trial to be well-tolerated and successful on multiple biomarkers of NASH, but raised concerns about possible interactions with other drugs. BI is continuing to develop the drug in other studies, such as in diabetic retinopathy, and the company said it remains committed to developing other drugs for NASH.

Shares of Pharmaxis were down more than 40% on the Australian Stock Exchange when the market closed Wednesday. BI, based in Ingelheim am Rhein, Germany, is the largest privately owned drugmaker.

“We are disappointed that BI 1467335 is not advancing in NASH,” Pharmaxis CEO Gary Phillips said in a statement. “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.”

BI isn’t the first company to suffer a setback in its NASH efforts. On Monday, Gilead Sciences said its Phase II study of the drugs firsocostat and cilofexor – testing the drugs in combination and as monotherapies – failed to show a statistically significant increase in the proportion of patients achieving at least one stage’s worth of improvement in fibrosis without worsening of the disease. Earlier this year, Gilead suffered two Phase III study failures of another drug it had been developing for NASH, selonsertib.

By contrast, Intercept Pharmaceuticals had only a minor setback earlier this week when the Food and Drug Administration scheduled an expert panel meeting for after the original date when it was supposed to decide on whether or not to approve its drug, obeticholic acid. An analyst wrote that Intercept’s drug is likely to become the first to win FDA approval and NASH, with strong uptake anticipated.

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