Clinical Trials

Date: 2018-01-11

Type of information: Initiation of the trial

phase: 2a

Announcement: initiation of the trial

Company: Boehringer Ingelheim (Germany)

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: diabetic retinopathy

Therapeutic area: Ophtalmological diseases

Country: Greece, Italy, Norway, Spain, UK, USA

Trial details:

The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME) (NCT03238963)

Latest news:

• On January 11, 2018, Pharmaxis announced dosing of the first patient in Boehringer Ingelheim’s Phase 2a clinical trial in patients with diabetic retinopathy (DR), triggering a €10 million (~A$15 million) milestone payment to Pharmaxis. The Phase 2a clinical trial of BI 1467335 in diabetic retinopathy will randomise 100 patients to either drug or placebo for a 12?week treatment period with an additional 12?week follow?up period. The study is expected to report in the second half of 2018. A subsequent Phase 2b study will seek to confirm and extend these findings.