Boehringer Ingelheim discontinues work on NASH therapy candidate

Boehringer Ingelheim and Pharmaxis announced that development of BI 1467335 for the treatment of nonalcoholic steatohepatitis would be discontinued, according to a press release.

“We are disappointed that BI 1467335 is not advancing in NASH,” Gary Phillips, CEO of Pharmaxis said in the release. “We look forward to further scientific discussion, when the full data and analysis from this phase 2a clinical trial and Boehringer Ingelheim’s recently reported phase I study are available for review.”

Boehringer Ingelheim previously acquired BI 1467335 from Pharmaxis in 2015.

Results from the phase 2a study in patients with clinical evidence of NASH showed that the treatment was well-tolerated with no related serious adverse events. Additionally, BI 1467335 met the prespecified target for inhibition of plasma amine oxidase copper-containing 3 activity compared with placebo, along with other clinically relevant changes in NASH biomarkers.

However, data from the phase 1 study indicated risk for drug interactions of the compound in patients with NASH, which led to the decision to discontinue clinical development.

Ongoing studies of BI 1467335 remain unaffected by the decision. These include a phase 2a study in patients with diabetic retinopathy for which the investigators have completed enrollment and expect a report in the second half of 2020.

Reference: www.pharmaxis.com