The first is the commencement of a phase 2 NASH trial by Boehringer Ingelheim, triggering the payment of an €18 million or circa A$25 million.
The second is completion of preclinical toxicology studies for the LOXL2 program which is the last step before commencing human phase 1 clinical studies.
Third will be the top line results from an international clinical trial of Bronchitol® (CF303) designed to meet the remaining clinical requirements of the Food and Drug Administration (FDA) in order to market the drug in the USA.
Pharmaxis ended the March quarter with $26.5 million cash and during the quarter, two major institutional shareholders increased their holdings to become the company’s largest holders.
Pharmaxis is a pharmaceutical research company with a portfolio including two respiratory products approved in various world markets and a research pipeline focused on areas of high unmet clinical need in inflammatory and fibrotic diseases.
The company’s product pipeline is founded on its expertise in the chemistry of amine oxidase inhibitors.
Catalyst #1: Phase 2 NASH trial
Pharmaxis’ partner Boehringer Ingelheim is on track to commence a phase 2 clinical trial of the drug PXS‐4728A for the liver disease NASH in the second quarter of 2017.
The commencement of the trial will trigger a milestone payment to Pharmaxis of €18 million (~A$25 million).
Catalyst #2: LOXL2 preclinical toxicology studies
Preclinical toxicology studies for the LOXL2 program which are being conducted with U.K. collaborator Synairgen are approaching completion.
This is the last step before commencing human phase 1 clinical studies in the second half of 2017 and move towards a formal partnering process.
Catalyst #3: Top line results from Bronchitol trial
A third international multicentre clinical trial of cystic fibrosis patients designed to meet the remaining requirements of the US Food and Drug Administration (FDA) was completed in February and is scheduled to report top line results in the current quarter.
Bronchitol is a precision spray‐dried form of mannitol, delivered to the lungs by a specially designed, portable inhaler.
Pharmaxis has partnered its work on Bronchitol for the U.S. with global pharmaceutical company Chiesi Farmaceutici SpA, who has funded US$22 million of the expected US$26 million trial cost.
The U.S. is the largest market for Bronchitol and the pending trial results will potentially make it available in clinics across the U.S.