The world is one step closer to scarless healing with clinical data released by the University of Western Australia (UWA) where their trials led by Professor Fiona Wood AM have delivered highly encouraging results from a topical cream that can reduce scar tissue formation.
The vital ingredient within the cream used is the drug PXS-6302 which was discovered by Australian biotech company Pharmaxis (ASX: PXS) before extensive preclinical work into the drug was executed in collaboration with UWA. Since progressing to Phase 1c human trials, expert review of the data has produced the world’s first proof that LOX (lysyl oxidase enzymes) inhibition reduces skin collagen.
Data collected from 42 patients revealed that treatment over a 3-month period with the topical cream met its primary objective of being well tolerated with a good safety profile. The cream also reached a secondary endpoint with patient data showing a 66% reduction in LOX which are responsible for the cross linking of collagen fibres implicated in adverse scarring. Collagen was reduced by an unprecedented 30%.
Leading the trials at UWA is the latest scientific development in Professor Wood’s distinguished career as one of the world’s most respected plastic surgeons in the field of scarring and burn recovery.
Earlier in her career, Wood blazed a trail in the field as the co-founder of Spray-on-Skin while her life-saving work in the field was well publicised as one of the heroes in the aftermath of the Bali Bombings. Now, the UWA trials have confirmed the potential of LOX inhibition to limit the biological process of scar formation.
“This exploratory clinical study has significantly enhanced our understanding of the role of LOX enzymes in scarring and the scar process itself,” said Prof. Wood.
“PXS‐6302 safely inhibits these key enzymes to a significant degree and leads directly to an unprecedented change to the scar composition that we have not seen with any other form of treatment.”
Patients that were enrolled in the Phase 1c trial presented with any type of scars older than 1 year and at least 10cm2. The average age of the scars treated was 12.8 years old. Being long-established and only treated over a short 3-month period, the appearances of the scars did not change visually. Based on the reduction in collagen achieved in the trial Professor Wood was confident that an improvement in scar appearance and physical characteristics would be seen if the patients were observed for a longer period.
“The collected data also bodes well for studying the effect of LOX inhibition on the prevention of scars after surgery and in younger scars where the remodelling process is more aggressive and probably more sensitive to intervention with a LOX inhibitor,” added Wood.
“This work is a particular passion of mine and I am looking forward to extending our collaboration with Pharmaxis for future studies.”
Scarring continues to be a major health issue worldwide where trauma events such as burns or lacerations can have an adverse affect on life quality both physically and psychologically. In the developed world alone, there are more than 100 million patients with scars after operations or trauma. Hypertrophic scars are those with structural changes where excess collagen contributes to the buildup of scar tissue and tightening of surrounding skin. This lack of elasticity often creates further issues when attempting to stretch the skin with current treatments in the global market for hypertrophic scars, valued at USD $3.5 billion per annum.
Most of those treatments however, such as compression therapy, silicone gel sheeting or cryotherapy) take place after a scar is formed whereas LOX inhibition from the trials has demonstrated an ability to prevent the scar forming all together based on the reduced collagen levels presented in the skin biopsies.
With this opportunity to address scar formation before they have lifelong effects on people. Pharmaxis CEO Gary Phillips is excited by the next steps for PXS-6302 and its research partners.
“The pre-clinical work conducted by Professor Wood’s team at UWA and published recently in Nature Communications clearly pointed to the significant role played by LOX enzymes in skin scarring,” said Phillips.
This first in man clinical study has underlined those findings and pointed the way for future clinical research for our pan-LOX inhibitors. I am pleased to announce an extension of our collaboration with Prof Wood and her team at UWA and look forward to updating further details in the near future.”
With encouraging results from the Phase 1c trials for PXS-6302, Pharmaxis will now consider plans for further clinical development in scars.
In a call with investors, Phillips outlined possibilities to target specific scars such as younger scars, post-surgery scars, keloids or surgical adhesions with a further update expected in the coming weeks.
While those planning discussions take place, Pharmaxis is on track to report new data from their Phase 2 clinical trials targeting myelofibrosis before the end of the year having recently conducted discussions with the FDA to establish a clear path to commercialisation.
Investors interested in updates on these trials from Pharmaxis can subscribe to their mailing list here.
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