No side effects! Bringer ingelham abandons Bi 1467335 for NASH indications

Fan Dongdong just two days ago, Gilead scientific's product line of nonalcoholic steatohepatitis (NASH) failed In a phase II study, neither single drug nor combination therapy could change the patients' liver scar There has been another setback in this area On December 18, local time, Boehringer Ingelheim and partner pharmaxis announced that their SSAO / VAP-1 inhibitor Bi 1467335 had no direct failure in the latest clinical research, but due to the interaction between the drug and other drugs, the two sides decided to abandon the development of the drug for the treatment of fatty liver disease In 2015, Boehringer Ingelheim purchased Bi 1467335 from pharmaxis for us $250 million, hoping that the drug could enter the Nash market with huge unmet treatment needs Bi 1467335 is an oral copper containing amine oxidase 3 inhibitor (aoc3) 1, which can block leukocyte adhesion and tissue infiltration during Nash inflammation In 2016, the US FDA awarded Bi 1467335 compound a fast channel qualification for NASH Although the drug has achieved the predetermined goal of "inhibiting the activity of aoc3 and enabling the clinical related changes of Nash biomarkers", it was found in the phase 1 test after drug withdrawal that the treatment with the drug will increase the "risk of drug interaction in NASH patients", which is the side effect that the two companies cannot solve at present The researchers did not specify which drug Bi 1467335 would interact with, but many NASH patients may be receiving other drugs, such as diabetes, cardiovascular disease treatment drugs Affected by the black swan incident, pharmaxis stock plummeted directly, almost halving Despite the "end of life" of Nash indications, Bi 1467335 is still in the process of testing other indications, including the phase 2A study of diabetic retinopathy, which has completed the recruitment of subjects and will report relevant test results in the second half of next year Currently, in the field of Nash, intercept and genfit, which are different from Bi 1467335 treatment mechanism, are in the leading position and are expected to obtain the first approval next year Source: Boehringer's $250m Nash drugs the skids as development path gets rockier 37