Clinical trials deliver promising data for anti-scar skin treatment

Patients who suffer from permanent scars are one step closer to a treatment that could alleviate both the physical and mental effects thanks to promising interim data released by clinical stage pharmaceuticals company Pharmaxis (ASX: PXS) and a team at the University of Western Australia, led by Professor Fiona Wood AM.

The trial of drug PXS-6302 commenced three months ago with 24 patients out of a targeted 50 patients enrolled in the SOLARIA2 study. Each enrolled into the trials having had a permanent scar of more than 10cm² in size, and had been receiving the topical treatment at the University of Western Australia (UWA) under Prof Wood’s guidance.

The 8 patients who commenced the first round of treatments were all receiving the Pharmaxis drug PXS-6302. They had skin biopsies taken at the end of the 3 months of treatment that showed excellent penetration of the skin, with inhibition of the lysyl oxidase enzymes that are responsible for the formation of scars.

Professor Fiona Wood said, “We have noted positive changes in appearance and pliability of scars in those patients on active drug that now need to be confirmed by the results from the placebo controlled phase of this trial later this year.”

“We are learning a lot as we move from the promising pre‐clinical work done at UWA and into the clinic where we have many patients who are in great need of a treatment that can improve both the cosmetic appearance of their scars and improve the functionality of their scarred skin; factors that have a huge impact on patient’s wellbeing.”

The remaining 42 patients enrolled in the SOLARIA2 study will receive either active drug or a placebo and have their skin biopsies taken at the end of their 3 month treatment period. Final results are expected to be published by June 2023. The aim is to provide definitive evidence of LOX enzyme inhibition that can modify scar tissue at a structural and biochemical level – essentially ‘“un-scarring the scar” as Professor Wood has previously described.

Further validating PXS-6302, a drug discovered and developed by Pharmaxis, is pre-clinical data that was recently released in medical journal Nature Communications, by Dr Mark Fear, Senior Research Fellow at the Stan Perron Centre for Excellence in Childhood Burns.

Dr Fear’s studies confirmed that the enzymes that lead to scarring, were inhibited by PXS-6302, thus playing a critical role in normalising collagen and elastin which enabled skin to heal without permanent scarring.

“In these scar models we found that topical application of PXS-6302 reduces collagen deposition and cross-linking and improves scar appearance without reducing tissue strength,” said Dr Fear.

“This is a unique way of modulating a critical stage in scar formation and maintenance and holds out great promise for the treatment of scars.”

The pre-clinical data has previously been favourably reviewed by the US Food and Drug Administration (FDA) which will assist Pharmaxis in any Investigative New Drug application in the pathway towards commercialising PXS-6302.

Beyond the ability to provide life-changing treatment to those suffering from permanent scars, the commercial opportunity for PXS-6302 is substantial with more than USD $19 billion spent in 2019 on scar treatments, of which none can ‘un-scar a scar’ like PXS-6302 has the potential to.

Pharmaxis CEO Gary Phillips presented the interim data results in further detail at an investor briefing which can be viewed below.

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