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Boehringer begins Phase IIa trial of BI 1467335 in patients with NASH.

M2 EQUITYBITES-August 25, 2017-Boehringer begins Phase IIa trial of BI 1467335 in patients with NASH


Medicines company Boehringer Ingelheim reported on Thursday the launch of a European and North American Phase IIa trial of BI 1467335 in patients with NASH.

Non-alcoholic fatty liver disease (NAFLD), the most common liver disorder in West, and its more serious form NASH, is highly prevalent amongst patients with type 2 Diabetes. NASH is a major cause of liver fibrosis and cirrhosis and is an area of high unmet medical need with no treatments currently available.

In 2015, Boehringer acquired BI 1467335 (formerly known as PXS-4728A) from Pharmaxis (ASX:PXS), a pharmaceutical company. In 2016, Boehringer Ingelheim obtained Fast Track Designation from the US Food and Drug Administration (FDA) for the development of BI 1467335 in NASH.

The company said BI 1467335 is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)1 and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

This multi-centre, double-blind design Phase IIa trial in 150 patients with clinical evidence of NASH's will establish proof of clinical principle, investigate suitable dosing as well as to evaluate the safety of BI 1467335. Patients will be randomised to either one of four dosages of BI 1467335 or to placebo for a 12-week treatment period.2 A subsequent Phase IIb study will seek to confirm and extend these findings.

Concurrently, Pharmaxis will receive EUR18m milestone payment in further endorsement of Boehringer's ability to generate value from its early stage pipeline.

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Publication:M2 EquityBites (EQB)
Date:Aug 25, 2017
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