Pharmaxis Ltd (ASX:PXS) has quickly adapted its operations to keep its clinical research work and Australian-based manufacturing on track during COVID-19.
Despite global disruption caused by the pandemic, chief executive officer Gary Phillips believes Pharmaxis remains a solid investment for the following reasons:
Boehringer AOC3 inhibitor acquired from Pharmaxis
It’s down but not out. A recent discussion with Boehringer emphasized that despite the decision to stop development in NASH, a separate clinical trial in diabetic retinopathy will complete on time (Q2 2020) and that a decision on its progression is expected in H2 2020.
Boehringer already has a plan for the next study should the current 3‐month phase 2a study show significant efficacy in this patient group.
LOXL2 partnering
The Lysyl Oxidase Like 2 (LOXL2) enzyme is fundamental to the fibrotic cascade that follows chronic inflammation in the liver disease NASH, cardiac fibrosis, kidney fibrosis, and idiopathic pulmonary fibrosis (IPF) and it also plays a role in some cancers.
The Pharmaxis drug discovery group developed two small molecule inhibitors to the LOXL2 enzyme that have completed phase 1 clinical trials and 3‐month toxicology studies.
The company is currently pursuing a number of different partnering options with international pharma companies to enable this drug to enter the clinic in phase 2 trials.
While slowed by the diversion of attention of potential partners in the last quarter there has certainly been no reduction in the number interested parties.
Anti‐cancer Systemic pan‐LOX program
This is the third distinct program from the company’s amine oxidase platform and, having shown promise in several cancer models, Pharmaxis now has its first phase 1 safety study in healthy volunteers successfully completed and sufficient data from long term toxicity studies to allow the company to conduct 6‐month phase 2 cancer studies.
Following discussion with key opinion leading clinicians Pharmaxis believes that myelofibrosis is a firm opportunity and preliminary feedback from the FDA has encouraged the company to submit an IND (investigational new drug) application mid‐ year with the aim of starting a 6‐month safety and efficacy study in primary myelofibrosis starting in Q4 2020.
Bronchitol US FDA review
Pharmaxis’ US licence partner Chiesi completed the human factor study requested by the FDA in its complete response letter last year and remain on schedule to submit its response to the FDA this quarter.
The US$10 million milestone due to Pharmaxis in the event of an approval would be payable on receipt of the launch stock which is forecast to be in Q4 2020.
Cash preservation is critical
In an environment reshaped by COVID ‐19, cash preservation is critical and Phillips remains confident that the company’s strategy of laying off development risk on projects that require significant investment via partnering, and fast tracking programs like the systemic pan‐LOX inhibitor which can reach clinical proof of concept with smaller shorter clinical trials, are the right blend of risk mitigation and value driving events for shareholders.
Pharmaxis has $20 million of cash on hand and other programs in its pipeline will receive minimal investment until the partnering of the LOXL2 program is completed and the Bronchitol FDA review is complete.
NWR Virtual Health Conference presentation
Gary Phillips will present at the NWR Virtual Health Conference to be held on Friday May 1 and Monday May 4 2020.
The CEO will provide details of recent progress in the Pharmaxis drug discovery pipeline and additional commentary on the information included in the company’s latest quarterly shareholder update.
The event is free and shareholders and investors should register in advance to view the presentation at https://t.co/sY5jB3KKEi?amp=1