Investor Centre

A recording of the Pharmaxis Investor conference call held 18 December 2019 at 9.15am is available here.

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today provided an update on its business plan following a decision by Boehringer Ingelheim (BI) not to progress studies of the AOC3 inhibitor acquired from Pharmaxis in 2015 for the treatment of NASH.

A second study of the drug in diabetic retinopathy with associated milestone payments will continue with future development to be decided by BI following completion of the current phase 2a study due to report 2H 2020.

Pharmaxis closed the September quarter with $23 million cash, and in October received its 2019 R&D tax incentive of $6.2 million. In addition, Pharmaxis anticipates receipt of a US$10 million milestone payment for Bronchitol® from its US licensee Chiesi in Q3 2020 subject to FDA approval midyear.

The company’s drug development pipeline includes two drug projects that can be brought to significant valuation points with the current cash position:

Boehringer Ingelheim and Pharmaxis Ltd today announced the discontinuation of the development of BI 1467335 for the treatment of NASH (non-alcoholic steatohepatitis). BI 1467335 was acquired from Pharmaxis in 2015.

In a 12 week Phase IIa trial investigating BI 1467335 in patients with clinical evidence of NASH, treatment was well tolerated and no related serious adverse events occurred. The study met the pre specified targets for inhibition of plasma amine oxidase copper-containing 3 (AOC3) activity by BI 1467335 compared to placebo as well as clinically relevant changes in NASH biomarkers. However, following assessment of another recently completed Phase I study, Boehringer Ingelheim decided not to further develop BI 1467335 in this indication based on the risk of drug interactions of the compound in NASH patients.

Further studies with BI 1467335, including a Phase IIa study in diabetic retinopathy which has completed recruitment and is due to report 2H 2020, remain unaffected by the decision.

Updated investor presentation

Shareholder update for the quarter ended 30 September 2019