The trial (NCT06807021) will be initiated at HHS’ Centre for Burn Research, which specialises in developing treatments and therapies to improve healing and quality of life outcomes for burn patients through evidence-based care.
FS2, a kynurenic acid product, was first identified as a potential drug candidate for clinical research by investigators at the University of British Columbia.
In preclinical trials of the topical cream compared with a leading competitor product, FS2 demonstrated superior prevention of scars as well as the breakdown and reduction of existing scars that occurred both externally and internally after injury, surgery or disease.
FS2 is unique in its therapeutic category as it targets scarring on a molecular level.
The objective of the study is to see how FS2 affects scar formation in people with burn injuries that need skin graft surgery. Notably, the study assessment will utilise 3D clinical imaging technology, alongside subjective rating scales, to objectively assess and measure scar healing.
Dr Carlos Camozzi, MD, PhD, Chief Medical Officer at BirchBioMed, said: “As experts in the development of products for scarring and other fibrosis-related disorders, we are delighted to enter this exciting new phase of our FS2 clinical programme."
“We see this trial as a pivotal moment in burn care and we continue to hear from our partnered physicians across the country that innovation is long overdue. There is considerable anticipation for FS2’s potential to transform the lives of millions of people suffering from disfiguring and often life-threatening scars.”
SGS Nutrasource’s collaboration with HHS represents the first of up to ten clinical sites in Canada earmarked to undertake this research. The first patients are expected to enrol by September 2025.
“Every aspect of this study has been carefully designed to prioritise patient experience and rigorously evaluate the product’s efficacy,” says Adam Kuttenkeuler, PMP, Project Manager at SGS Nutrasource.
“SGS Nutrasource is proud to lead this one-of-a-kind study across Canada, launching with such a prestigious research site.”
In addition to product manufacturing, quality and development, SGS Nutrasource provides BirchBioMed with extensive clinical and regulatory expertise at this pivotal point in its development.