Pharmaxis set to trigger another milestone

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A new boost for Pharmaxis with partner Boehringer Ingelheim deciding to initiate another trial for the compound discovered by the Sydney-based company.

Following an announcement earlier last week on progressing development of its LOXL2 inhibitor, the company announced more positive news in the development of BI 1467335, an oral inhibitor of amine oxidase, copper containing 3, which works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying non-alcoholic steatohepatitis (NASH).

Boehringer Ingelheim is initiating a new Phase 2a trial of BI 1467335 in a second indication, following the previously announced Phase 2a trial studying the compound in 150 patients with clinical evidence of NASH, targeting a severe diabetes complication.

According to CEO Gary Phillips, “I’m delighted that our partner Boehringer Ingelheim has decided to pursue a second indication for the drug acquired from Pharmaxis in 2015. It will be very rewarding for the Pharmaxis team to see another group of patients benefit from our initial work.

"The deal structure negotiated with BI recognised the potential that the drug had in multiple indications so expanding the development plan to include diabetic retinopathy as well as NASH means that we will receive a €10m milestone payment when the first patient is dosed in the DR Phase IIa study and that all the potential development milestones in the deal (€418.5m /A$625m), would be payable to Pharmaxis should both indications be approved.

"Our belief that Boehringer Ingelheim would be a company that sought to maximize the potential of the drug was central to our choice of partner and this latest development reaffirms that view,” he said.

According to Dr Christopher Corsico, chief medical officer of Boehringer Ingelheim, “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 new trial, ROBIN (Randomised study of Orally administered BI 1467335 in patients with Non-proliferative diabetic retinopathy without center-involved diabetic macular edema), will involve 100 patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME).

The primary objectives of the new trial are to establish proof of clinical principle and to evaluate the safety and tolerability of BI 1467335. Patients will be randomized to either BI 1467335 or to placebo for a 12-week treatment period with an additional 12-week follow-up period afterwards.