Boehringer Ingelheim Completes Enrollment of Phase 2a Clinical Trial of Pharmaxis Developed Drug in NASH
Release Date: 25/02/2019 11:45am
Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced completion of enrollment in Boehringer Ingelheim’s Phase 2a clinical trial in patients with non-alcoholic steatohepatitis (NASH). The trial is assessing BI 1467335 (formerly known as PXS-4728A), an oral inhibitor of amine oxidase, copper containing 3 (AOC3), that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH. BI 1467335 was acquired from Pharmaxis in May 2015 and is also in an ongoing Boehringer Ingelheim Phase 2a clinical trial for diabetic retinopathy.
The Phase 2a NASH trial is a multi-centre, double-blind design in 114 patients with clinical evidence of NASH. The trial is being conducted in nine countries across North America and Europe. The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335. Patients have been randomized to either one of four dosages of BI 1467335 or to placebo for a 12-week treatment period followed by a 4-week observation period. The trial is expected to report in the second half of 2019. A subsequent Phase 2b study will seek to confirm and extend these findings.
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