Date: 2017-08-24
Type of
information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany) Pharmaxis (Australia)
Product: BI 1467335 (formerly known as PXS-4728A)
Action
mechanism:
- protein inhibitor/vascular adhesion protein-1 (VAP-1) inhibitor. PXS4728A is a highly selective oral small molecule inhibitor of vascular adhesion protein-1 (also known as amine oxidase, copper containing 3 (AOC3)) that has shown activity in preclinical investigation in non-alcoholic steatohepatitis (NASH). This oral inhibitor works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.
- Pharmaxis has developed it through to phase 1 clinical studies, demonstrating oral bioavailability, long-lasting target inhibition and good tolerability and safety.
- Boehringer Ingelheim has signed an Option and Asset Purchase agreement for PXS4728A that expired on May 15, 2015. In 2016 Boehringer Ingelheim obtained Fast Track Designation from the FDA for the development of BI 1467335 in NASH.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic
area: Liver diseases - Hepatic diseases
Country: Canada, Netherlands, USA
Trial
details:
- The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.
- To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, ?-GT and CK18 fragments). Safety will be assessed throughout the study to provide key information regarding the use of BI 1467335 in patients with NASH. (NCT03166735)
Latest
news: • On August 24, 2017, Boehringer Ingelheim and Pharmaxis announced that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015.
This Phase IIa trial is a multi-centre, double-blind design in 150 patients with clinical evidence of NASH. The primary objectives are to establish proof of clinical principle, investigate suitable dosing, and to evaluate the safety of BI 1467335. Patients will be randomized to either one of four dosages of BI 1467335 or to placebo for a 12?week treatment period. A subsequent Phase IIb study will seek to confirm and extend these findings.
Is
general: Yes
