Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) announces that the clinical trial of its topical anti-scarring drug PXS-6302 has completed recruitment with the last of the 42 patients dosed earlier this week.
The study is being conducted by the University of Western Australia (UWA) under the leadership of Professor Fiona Wood AM, director of the West Australian Burns Service.
Placebo arm of the trial
The trial, known as SOLARIA2, is being conducted in 50 adult patients treated for scars of greater than one year in age and more than 10 square centimetres in size for a period of three months.
The first eight patients treated were on the active drug, while the following 42 were randomised 1:1 to active or placebo.
Results are expected in the second quarter of the new year, assessing safety profile, improvements in scar appearance and function, and evidence that LOX inhibition is modifying scar tissue at a structural and biochemical level.
Active drug showed positive changes
Preliminary results were released in September from the open label phase treating eight patients for up to three months with the active drug. They showed a high level of inhibition of enzymes and changes in biomarkers that are implicated in scarring.
“We have noted positive changes in appearance and pliability of scares in those patients on active drug that now need to be confirmed by the results from the placebo-controlled phase of this trial,” Professor Wood said.
When the final results are in, Pharmaxis hopes to confirm an acceptable safety profile, improvements in scar appearance and function for patients on active drug relative to those treated with placebo and evidence that LOX inhibition is modifying scar tissues at a structural and biochemical level.
“The study being conducted with UWA has recruited rapidly and we now eagerly await the outcome of this placebo-controlled study,” Pharmaxis CEO Gary Phillips said.
Encouraging data
“The study being conducted with UWA has recruited rapidly and we now eagerly await the outcome of this placebo-controlled study.
"Interim data from the first patients that were on active treatment were encouraging and we are already working with Professor Wood and her team to design a follow-up study that will address the need for objective endpoints to meet anticipated regulatory hurdles and explore further indications that suit the profile of PXS-6302.”
PXS-6302 was discovered by the Pharmaxis research team at the company’s Frenchs Forest laboratories.
The project was supported by a National Health and Medical Research Council (NHMRC) development grant that funded extensive pre-clinical work executed in collaboration with UWA.
The ongoing clinical trial in patients with established scars and the planned follow-up study will both be conducted at the Fiona Stanley Hospital in Perth with financial support from Pharmaxis.