Boehringer Ingelheim has launched a Phase IIa clinical trial (ROBIN) of its product candidate BI 1467335 to treat patients with non-proliferative diabetic retinopathy (NPDR).
Acquired from Australian pharmaceutical research firm Pharmaxis in 2015, BI 1467335 is an oral inhibitor of amine oxidase, copper containing 3 (AOC3).
The multi-centre, double-blinded Phase IIa ROBIN trial will evaluate BI 1467335 in 100 subjects with moderately severe to severe NPDR without centre-involved diabetic macular edema (CI-DME).
Boehringer Ingelheim chief medical officer Dr Christopher Corsico said: “We are delighted to advance BI 1467335 into Phase II clinical research for a second indication, targeting a severe complication of diabetes. This is important news for the millions of patients threatened by losing their vision.
“Boehringer Ingelheim is committed to developing novel treatments designed to address unmet medical need and improve public health and looks forward to studying this novel compound in NPDR patients.”
The trial’s primary objectives are determination of proof-of-clinical principle and assessment of the safety and tolerability of BI 1467335 during a 12-week treatment and an additional 12-week follow up periods.
Boehringer plans to perform a subsequent Phase IIb trial to validate and extend the Phase IIa results.
According to its agreement with Pharmaxis, Boehringer will provide a €10m milestone payment upon initiation of dosing in the ROBIN trial.
In addition to the NPDR clinical development programme, BI 1467335 is being studied in a Phase II programme for the treatment of non-alcoholic steatohepatitis (NASH).