Phase Ib follows the success of phase Ia which commenced in February 2019 and consisted of 40 healthy subjects divided into five groups, each taking a dose or a placebo.
The drug was well tolerated and no safety signals were identified in phase Ia.
Phase Ib involves 16 subjects in two groups with each group receiving a different dose or placebo for 14 days.
The clinical trial is due to report in the March quarter of 2020.
Aim to progress to clinical proof of concept studies
Pharmaxis’ CEO Gary Phillips said: “The second part of this study was originally due to report mid‐year but we delayed it while we completed 3‐month toxicity testing to further de‐risk the drug.
“This means that with successful completion of this phase 1 study we will have all the data required to support the commencement of clinical proof of concept studies in either myelofibrosis or pancreatic cancer.
“Pharmaxis plans to discuss this program with the FDA in coming months prior to filing an IND that supports entering phase 2 studies in 2H 2020.”
Proprietary technology to be used
Phillips added: “Our expertise in the biology and chemistry of lysyl oxidase inhibitors, including the LOX and LOXL2 programs has been featured in a number of international conferences and publications in recent months.
“We have developed proprietary technology to measure LOX and its related family of enzymes in both animal models and human plasma that enables us to clearly understand the role these enzymes have in fibrotic disease.
“This will significantly aid patient selection and proof‐of‐mechanism in the upcoming phase 2 trials.”
Pharmaxis ranked in top 100
Pharmaxis was recently included in a report ranking it among the top 100 most innovative pharma companies in the Asia Pacific (APAC) region.
The report was prepared by Cortellis and is entitled ‘Pharmaceutical innovation in the APAC region’.
It studied a cohort of 929 companies including multi-nationals across 14 countries/regions that have or are developing innovative pharmaceutical products.
Notably, 14 Australian companies featured in the top-100 and Pharmaxis was the second-highest ranked.