Phase I Study Shows Topical PXS-6302 Is Safe and Tolerable for Skin Scar Treatment

A recent Phase I clinical trial conducted by the University of Western Australia's Burn Injury Research Unit, in collaboration with the Fiona Wood Foundation, has demonstrated that the topical application of PXS-6302, a pan-lysyl oxidase inhibitor, is generally well tolerated in individuals with established skin scars. Over a period of three months, participants applying the drug experienced minimal adverse effects, primarily localized reactions at the application site, which led to discontinuation in a few cases. Importantly, the treatment resulted in notable biochemical changes within the scar tissue.

PXS-6302 functions by inhibiting lysyl oxidase enzymes that are responsible for collagen cross-linking in the extracellular matrix. Excessive cross-linking is associated with scar stiffness and fibrosis. In the study, 50 adults with scars older than one year applied the cream either openly or in a randomized fashion. The application involved microdosing devices delivering 200 microliters of the medication, with biopsies taken to evaluate collagen activity, hydroxyproline levels, and total protein composition.

Results indicated a significant decrease in lysyl oxidase activity and collagen cross-linking in the treated scars. Biopsies also revealed a reduction in hydroxyproline and overall protein content, suggesting a modulation of scar tissue on a biochemical level. Advanced imaging showed increased density of small blood vessels and higher tissue attenuation in the treated areas, indicating potential tissue remodeling.

The findings are encouraging because they highlight the safety of topical PXS-6302 and its ability to influence the extracellular matrix, a key factor in scar formation and appearance. These promising results support the advancement of PXS-6302 into Phase II trials, which aim to assess its efficacy in improving scar texture and appearance more comprehensively.

This innovative approach offers a less invasive, potentially more effective alternative to current scar management options, such as surgery, laser treatments, or corticosteroid injections, which can be painful and inconsistent in results. The study underscores the potential for enzyme-targeted therapies to improve cosmetic and functional outcomes for individuals with mature scars, ultimately enhancing their quality of life.