Boehringer Ingelheim said that it has decided to discontinue its development of BI 1467335, nonalcoholic steatohepatitis (NASH) treatment candidate acquired from Sydney-based Pharmaxis. The company acquired the candidate substance for $250 million in 2015.
According to Boehringer Ingelheim, in a 12-week phase 2a trial investigating BI 1467335 in patients with clinical evidence of NASH, the treatment was well-tolerated, and no related serious adverse events occurred. The study met the pre-specified targets for inhibition of plasma amine oxidase copper-containing 3 (AOC3) activity by BI 1467335 compared to placebo as well as clinically relevant changes in NASH biomarkers.
However, following the assessment of another recently completed phase 1 study, Boehringer Ingelheim decided not to develop BI 1467335 in this indication based on the risk of drug interactions of the compound in NASH patients.
Boehringer Ingelheim noted that the decision would not affect other studies in BI 1467335, including a phase 2a clinical research of diabetic retinopathy.
“The phase 2a clinical trial of diabetic retinopathy has been recruited, and the results will be announced in the second half of next year,” the company said in a statement.
Despite hitting a snag in their NASH treatment development, Boehringer Ingelheim said it is developing various portfolios for the illness in partnership with companies such as Yuhan, Dicerna and Mina.