The skin is one of the most overlooked, complex and essential organs. It is the body’s first line of defence against dehydration, infection, and injury and plays a role in thermoregulation, vitamin D absorption and the nervous system.
Throughout the course of life we are bound to end up with scars from adventures and mishaps, but it’s the serious scars from major trauma or burns that can have untold consequences affecting form and function. One of the most prolific researchers in the field of skin scarring, Professor Fiona Wood AM puts it perfectly: “scars are more than skin deep.” Major scars can have serious complications to the patient far beyond aesthetic discomfort. The psychological and physical tolls of scarring are well documented and yet, there remains limited pharmacological approaches to eliminate scars.”
That’s where Pharmaxis (ASX: PXS) comes in. The little Aussie biotech has proven themselves as beyond capable of keeping up in the highly competitive sector, having already brought two drugs to market, with another two in clinical trials for multiple indications. PXS-6302 is their lead asset designed to target and ameliorate skin scars and holds serious promise as a revolutionary drug with applications in dermatology, surgery and the multi billion dollar cosmetics industry. The untapped commercial value isn’t the a driver for Professor Wood who is leading the trials for Pharmaxis. “Scarring is more than skin deep,” she says “and can have a profound effect on people over their life.”
Professor Wood is arguably the most qualified person to pilot the PXS-6302 trials, having invented and commercialised Spray-On Skin under Avita Medical (ASX: AVH) and receiving an Order of Australia for her contributions to medicine.
Avita attracted massive investment from leading biotech hedge funds like Karst Peak. Investors paying attention would have been interested to see that Karst Peak took a large position in Pharmaxis as a major institutional shareholder last year, a huge vote of confidence for Professor Wood and the drug she is trialling alongside colleagues at the Burn Injury Research Unit at the University of Western Australia.
The investigator led Phase 1 clinical trial of PXS-6302 commenced in the first quarter of 2021 and gleaned promising results in healthy volunteers. The topical drug cleared these trials proving to be safe and well tolerated. Results showed full inhibition of the lysyl oxidase enzymes within the skin, with minimal systemic exposure.
PXS-6302 is based on the same technology as Pharmaxis lead asset PXS-5505 which is currently in Phase 2 trials for multiple cancers. Both antifibrotic medications, they are designed to inhibit enzymes that contribute to scarring and fibrosis which is a key disease mechanism in many conditions.
Next up for PXS-6302 is a longer term study in 50 patients with established scarring. The Phase 1c study will run for 3 months with endpoints around safety, tolerability and effects on scar structure and appearance. Results are expected in the second half of the year and are set to be a significant value driver for the Company. Additionally, a second trial looking at the drug’s efficacy in burns is being planned, with patient recruitment set to commence in the second half of the year.
With a near unlimited market potential for a drug that can melt away scars, Pharmaxis could have a serious game changer on their hands for major burns, trauma, scar revisions and keloid scar treatment.
In the US alone over USD $7.5 billion is spent on burn care. Over 80 million surgical incisions are made, and 12 million traumatic lacerations seen in hospitals each year, all with a potential to scar. And of course, we can’t forget the applications in more minor scars and prophylactic use, both of which significantly expand the market potential of PXS-6302 even further.
Professor Wood recently presented on clinical applications for lysyl oxidase enzyme inhibition in skin scarring and fibrosis at Pharmaxis’ R&D Showcase Webinar series, an online event where the Company gave a detailed view into its technology and collaborators before announcing results for multiple trials later in the year. Professor Wood’s presentation outlined the clinical development strategy of the trials and explained more about the importance of a drug like PXS-6302. You can watch the presentation here.
Pharmaxis invites interested investors to a special investor briefing on Friday 29th April 2022 at 11am AET. Register for the event here to hear from CEO Gary Phillips as he updates the market on all trials and aspects of the business.
Samantha Freidin is a business journalist at Emerald Financial whilst also completing a Masters of Marketing and Digital Communications at Monash University.
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