Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) has made great strides toward commercialisation in a Phase 1C study of its topical Pan LOX inhibitor, achieving a well-tolerated safety profile and a marked change in scar composition.
Importantly, the study’s results mark the first-ever proof that LOX inhibition reduces skin collagen, having achieved a 30% reduction in the scar’s collagen content.
The company says this proof-of-concept supports its decision to expand into new skin fibrosis indications in collaboration with Professor Fiona Wood and researchers at The University of Western Australia (UWA).
High tolerability and inhibition
Led by renowned surgeon Professor Fiona Wood AM and a team of researchers at The University of Western Australia (UWA), the study aimed to evaluate the safety and tolerability of Pharmaxis' drug PXS-6302 when topically applied to established scar areas in adult patients.
“This exploratory clinical study has significantly enhanced our understanding of the role of LOX enzymes in scarring and the scar process itself,” UWA Professor Wood said.
“PXS-6302 safely inhibits these key enzymes to a significant degree and leads directly to an unprecedented change to the scar composition that we have not seen with any other form of treatment.
“We estimate that up to 50% of the excess collagen in these patients’ scars has been removed and while the length of this Phase 1c safety study was not sufficient to change the appearance of an established scar the remodelling process will be ongoing and I’m confident we would see an improvement in scar appearance and physical characteristics if we observed them for longer.
“The collected data also bodes well for studying the effect of LOX inhibition on the prevention of scars after surgery and in younger scars where the remodelling process is more aggressive and probably more sensitive to intervention with a LOX inhibitor.
“This work is a particular passion of mine, and I am looking forward to extending our collaboration with Pharmaxis for future studies.”
Researchers collected skin biopsies to measure enzyme inhibition and assess scar composition.
Additionally, a visual and physical evaluation of the scars was included as an exploratory endpoint as Pharmaxis couldn’t determine the necessary length of treatment from pre-clinical data alone.
No serious adverse events were reported and only two patients withdrew from the study after reporting redness and itching at the site of application which resolved after treatment was stopped.
Extension of UWA collaboration
“The pre-clinical work conducted by Professor Wood’s team at UWA and published recently in Nature Communications clearly pointed to the significant role played by LOX enzymes in skin scarring,” Pharmaxis CEO Gary Phillips said.
“This first in human clinical study has underlined those findings and pointed the way for future clinical research for our pan-LOX inhibitors.
“I am pleased to announce an extension of our collaboration with Professor Wood and her team at UWA and look forward to updating further details in the near future.”