Investor Centre

Media release in relation to today's announcements.

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) has received a R&D tax incentive of $5,048,452 in relation to the 2020 financial year. The receipt of this incentive adds to the Company’s cash funds, which were $15 million at 30 June 2020. 

Pharmaxis CEO Gary Phillips said, “The R&D tax incentive is a significant source of non-dilutive funding for the Company’s development of new drugs, providing a 43.5% cash payment in relation to eligible research expenditure. Pharmaxis’ current drug development focus is the commencement of a phase 1/2 clinical trial of its pan-LOX inhibitor PXS-5505 in myelofibrosis which was recently given permission to proceed by the US Food and Drug Administration (FDA) under its Investigational New Drug program. PXS-5055 has also been granted orphan drug designation by the FDA for the treatment of myelofibrosis.”

• BI 1467335 was acquired from Pharmaxis in 2015 as part of Boehringer Ingelheim’s growing Retinal Health R&D pipeline portfolio.
• Boehringer Ingelheim has terminated the agreement with Pharmaxis with 90 days’ notice during which time Pharmaxis can request return of all existing data and intellectual property. 
• Pharmaxis will continue its development of small molecule amine oxidase inhibitors with a phase 2 study in myelofibrosis due to commence later this year.
• Boehringer Ingelheim will continue to advance its comprehensive portfolio of next generation retinal therapy approaches.

Boehringer Ingelheim and Pharmaxis Ltd today announced the discontinuation of the development of anti-inflammatory AOC3 inhibitor BI 1467335 for the treatment of patients with moderate-severe non-proliferative diabetic retinopathy (NPDR). BI 1467335 was acquired from Pharmaxis in 2015 and Boehringer Ingelheim will now terminate the agreement.

In a Phase IIa trial in patients with moderate-severe NPDR, BI 1467335 met its primary endpoint in ocular safety with the treatment being well tolerated. Boehringer Ingelheim decided not to further develop BI 1467335 in this indication based on the lack of a clear efficacy signal and risk of dose dependent drug interactions of the compound in NPDR patients identified in another Phase I study.

Pharmaxis CEO, Gary Phillips said, “We understand Boehringer Ingelheim’s decision to stop development of BI 1467335 in NPDR based on the risk of dose dependent drug interactions at the dose level that was tested in the Phase IIa trial. Based on recent publications AOC3 remains an important clinical target. We will review the data collected in more detail to evaluate potential opportunities in other indications that already have supportive pre-clinical data and where the risk of drug interactions are of less concern. In the meantime, we look forward to the upcoming FDA decision on granting a marketing authorisation for Bronchitol in the US cystic fibrosis market and our focus remains on advancing our anti-cancer pan-LOX inhibitor program into a phase 2 myelofibrosis study following the recent IND approval.”