Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) is targeting a potential breakthrough treatment for patients with problematic scar tissue to service unmet demand and a global market estimated at US$3.5 billion per year.
The three-month, placebo-controlled study, led by renowned surgeon Professor Fiona Wood AM and researchers at the University of Western Australia, will assess the safety and tolerability of the once-daily application of the drug candidate PXS-6302 when applied to established scar tissue on adult patients.
Efficacy is also an endpoint of the trial – as well as conducting visual and physical assessments of the scar tissue, the team will take skin biopsies to study the impact on scar structure.
Scar breakthrough
“Scars are a constant reminder of trauma, with both physical and psychological impact,” Professor Wood said. "Our aim is to reduce the scar and reduce the impact. Long‐term scars are notoriously hard to improve, so it is potentially ground‐breaking that a simple cream may make a difference.”
PXS-6302 is a first-in-class inhibitor of lysyl oxidase enzymes (LOX), which are involved in the formation and maintenance of scars. This is a potential breakthrough treatment for patients with problematic scars, in a market estimated at US$3.5 billion per year.
Pharmaxis’ research team discovered the drug candidate at the company’s Frenchs Forest laboratories. The project was supported by a National Health and Medical Research Council (NHMRC) development grant, which funded pre-clinical work done in collaboration with UWA.
The clinical trials in patients with established scars and patients with burns will be conducted at Fiona Stanley hospital in Perth with financial support from Pharmaxis.
Worldwide health issue
Scar formation following a burn or skin injury is a considerable health issue worldwide.
Following an injury, the body is unable to regenerate normal skin, and the repair process can lead to scar formation.
Scar tissue is both aesthetically and functionally inferior to normal skin, and can impact not only the bodily function for a patient, but also their mental health.
Key factors in the poor appearance and pliability of scars, and in particular hypertrophic scars, are the changes to the structure and quality of collagen in the dermal layer.
Unmet global need
Current treatments aim to rectify the scar in the acute phase – during wound healing and scar maturation – through options such as compression therapy, silicone gel sheeting or later when the scar is established by using cryotherapy, scar revision or laser therapy.
LOX plays a critical role in scar formation by cross-linking the collagen fibres. The resulting changes in collagen structure and increased rigidity of the tissue stimulates greater production of collagen and LOX which in turn leads to more scar tissue.
Next steps
Pharmaxis and its collaborators at UWA will now test if inhibiting LOX in established scar tissue with PXS‐6302 can safely and effectively improve scarring when administered as a cream once a day for a three‐month period.
“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,” Dr Mark Fear, senior research fellow at the Stan Perron Centre for Excellence in Childhood Burns, said.
“It is really exciting to be commencing studies with PXS-6302 in people with established scars as a next step towards better scar treatment.”
Pharmaxis CEO Gary Phillips added: “We place enormous value on our collaboration with Fiona Wood and the team at UWA. They identified the opportunity of using our expertise in drug development, and extensive knowledge of lysyl oxidase enzymes, to help patients with scars and have provided the clinical leadership to get this study underway.
“I look forward to reporting on the results later this year for a project that has significant potential both clinically and commercially.”