While clinical trials could be tricky for companies who struggle to convince fearful and pessimistic volunteers to participate, luckily this is not the case for clinical stage drug developer Pharmaxis (ASX: PXS). The Company has wrapped up patient recruitment of its topical anti scarring drug PXS-6302, with the last of the 42 patients dosed earlier this week.
The trial, known as SOLARIA2 is being conducted by the University of Western Australia (UWA) under the leadership of Professor Fiona Wood AM, Director of the Western Australia Burns Service. The trial involves treating 50 adult patients, using a topical cream, with scars of greater than one year in age and over 10 cm in size, over a three-month period. The first 8 patients were treated using the active drug, while the remaining 42 were randomised 1:1 to active or placebo.
According to Professor Fiona Wood, the preliminary results of the trial released in September 2022 showed positive changes in appearance and pliability of scars in patients, drawing widespread attention from mainstream media which broadcast these breakthroughs nationwide.
Gary Phillips, Pharmaxis CEO, was pleased with how quickly the UWA study finalised recruitment, highlighting the public interest in the trials garnered by Professor Wood.
“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,” said Phillips.
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 which funded extensive pre-clinical work done 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.
Full results of the Phase 1 trial are due to be released around June 2023. Pharmaxis hopes to confirm an acceptable safety profile, improvements in scar appearance, function for patients on active drug compared to those treated with placebo, and evidence that LOX inhibition is modifying scar tissue at a structural and biochemical level.
In 2019, the total scar treatment market was valued at more than USD $19 billion with the segment for keloid and hypertrophic scars valued at $3.5 billion.
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