Pharmaxis Ltd (ASX:PXS) has now completed the first year of operation following a business restructure which concluded with the sale of our drug candidate PXS-4728A to Boehringer Ingelheim (Boehringer) in May of 2015.
Progress under the new business model over the 2016 financial year has been substantial.
Importantly, Boehringer’s most recent status report on the development program for PXS-4728A has again confirmed its expectation that a phase 2 trial of PXS-4728A will commence in the first quarter of 2017, at which time a milestone payment of approximately A$25 million will be payable to Pharmaxis.
Gary Phillips, CEO, commented: "I believe Boehringer to be a perfect partner for this drug.
"It is a company with an extensive metabolic franchise and a clear belief in SSAO as a well validated target in NASH – an increasingly common disease with a high unmet need and a huge potential market.
"Our drug is Boehringer’s lead clinical candidate for this new and emerging market so there is a great strategic fit that I expect will benefit Pharmaxis and its shareholders for many years."
Drug discovery program
Pharmaxis Ltd's drug discovery program to develop new drugs for fibrotic diseases such as NASH and pulmonary fibrosis (IPF) has delivered several very suitable drug candidates that the company will now assess in conjunction with its UK collaborator Synairgen to determine which should be progressed into human clinical trials in 2017.
The search for good anti fibrotic medications remains highly competitive and the once-a-day oral small molecule inhibitors of the enzyme LOXL2 produced by the company's in house program offer great hope for patients.
Phillips added: "Interest in this program from large pharmaceutical companies with whom we have an ongoing dialogue remains strong and is actively shaping our pre-clinical development program.
"Our other drug discovery programs have also made substantial progress.
"In particular the neuro inflammation program where we have identified a lead compound and have started assessing the appropriate disease indication for further development based on feedback from potential partners."
Bronchitol clinical trial
Early in the month the company completed the recruitment of its phase 3 Bronchitol clinical trial in cystic fibrosis.
That trial is designed to meet the remaining clinical requirements of the complete response letter received from the US Food and Drug Administration (FDA) in 2013.
Pharmaxis Ltd expects to receive the results of the trial in the second quarter of 2017 and assuming a positive outcome, the submission of the trial results to the FDA by Chiesi later that year.
Well-funded
The company finished the financial year with a cash balance of $39 million and net cash usage over the year of $15 million.
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