Pharmaxis Ltd's novel topical drug treatment (PXS‐6302) for scarring has cleared the phase 1 clinical trials and will now advance to the next stage of development in patients.
According to the company, a study conducted on healthy volunteers led by renowned surgeon Professor Fiona Wood has revealed that its drug candidate PXS‐6302 has demonstrated good tolerability and full inhibition of the enzymes being targeted to prevent scarring.
The phase I trial tested four different strengths formulated as an easy to apply cream in four subjects as a single dose, scaling to the highest dose applied daily for seven days in a further six subjects.
Positive results
The positive results from the study, which was conducted by a research team at the University of Western Australia (UWA) and Fiona Stanley Hospital, have triggered the next steps in initiating a longer-term study in patients with scars.
In welcoming the early study results, Professor Wood said: “Scars are a constant reminder of trauma with both physical and psychological impact. Our aim is to reduce the scar and reduce the impact.
“We have two studies planned with Pharmaxis; this first one in established scars and an additional one in patients with burn injuries after they have had surgery.”
PXS-6302 discovery
The drug candidate ‘PXS‐6302’ was discovered by the Pharmaxis research team at the company’s French Forest Laboratories (NYSE:FRX) in Sydney.
The project was supported by a National Health and Medical Research Council (NHMRC) development grant funding extensive pre‐clinical work executed in collaboration with UWA.
PXS-6302 has shown promising results in pre‐clinical models of scar tissue development under the direction of Dr Mark Fear, a senior research fellow at the Stan Perron Centre for excellence in childhood burns.
Dr Fear said: “We now understand from our research that even scars which are stable and many years old are in fact replenishing a significant proportion of mature, stiff collagen in a matter of a few months.
“This presents an opportunity for a drug like PXS‐6302 to potentially improve even established scars.”
Preparing for next study
The next clinical study in patients with established scars and patients with burns will be conducted, under the guidance of Professor Wood at Fiona Stanley Hospital in Perth, with financial support from the company and is scheduled to start in the fourth quarter of 2021.
UWA School of Biomedical Sciences senior research fellow and principal investigator of the study
Dr Kylie Sandy‐Hodgetts said: “Based on the encouraging results from the phase 1 study in healthy volunteers, we are now preparing for a study in patients with established scars.
“We will be investigating the safety of 3 months’ treatment with PXS‐6302, and exploring if 3 months’ treatment with PXS‐6302, at a dose that we now know will significantly inhibit an enzyme implicated in scar formation, can make a difference to both the appearance and structure of their scars.”
Pharmaxis shares have been as much as 8.33% higher to 13 cents.