HN Summary

• Hamilton Health Sciences’ Centre for Burn Research is leading a national Phase II/III clinical trial testing a novel topical treatment designed to reduce scarring and improve healing after serious burn injuries.

• The study evaluates FS2, a naturally based compound applied directly to the skin that targets inflammation and scar formation at a molecular level, using advanced 3D imaging to measure outcomes.

• As the first Canadian site for this trial, HHS is advancing innovation in burn care while offering patients early access to a promising new therapy.

Hamilton Health Sciences’ (HHS) Centre for Burn Research is the first site in Canada to test an innovative new topical treatment for reducing scarring and supporting healing after a serious burn.

Researchers at the Centre for Burn Research are exploring new and better ways to improve healing and long-term recovery for people with burn injuries. The research centre is located beside Hamilton General Hospital (HGH), home to the Regional Burn Centre where patients with serious burns receive care. This close connection allows the research team to work alongside the very patient population they aim to help.

“Hamilton Health Sciences is a leading Canadian research hospital, giving our patients opportunities to be among the first to try promising new treatments and therapies,” says Dr. Marc Jeschke, HHS’ vice president of research and innovation, chief scientific officer, and medical director of the Regional Burn Centre. “We’re very excited to bring this new treatment option to our patients through this trial.”

Scarring can tighten skin, restrict movement and cause pain, itching and discomfort. It can affect how the skin looks and functions, making it harder to heal or protect the body. And it can impact a person’s mental health and self-confidence.

This Phase II/III randomized study by Canadian biopharmaceutical company BirchBioMed Inc. will be led by the HHS Centre for Burn Research with BirchBioMed’s contract research organization (CRO), SGS Nutrasource.

BirchBioMed Inc. is an expert in the development of products for scarring and other fibrosis-related disorders, autoimmune therapeutics and developing new ways to improve transplants. A CRO helps plan and run research studies for organizations like drug companies.

Targeting scarring on a molecular level

Randomized trials are considered the gold standard in clinical research. With these trials, participants are randomly assigned to groups, with one group getting the new treatment being tested, and another group receiving standard treatment or a placebo.

A Phase II/III randomized study tests a new treatment in two stages. In Phase II, researchers see if the treatment is effective and safe enough to move forward. If it shows promise, it advances to Phase III for testing in a larger group of people to confirm how effective it is compared to the usual care.

This study will test the naturally-based compound FS2 (kynurenic acid) as a topical cream for burn treatment. It’s designed be applied directly to the skin. Kynurenic acid has properties that can help reduce inflammation and protect tissues from damage caused by the body’s intense immune response after a burn injury. This could help limit scarring and improve recovery. FS2 is unique in its therapeutic category since it targets scarring on a molecular level.

This study is looking at how FS2 affects scar formation in people with serious burn injuries that need skin graft surgery. The assessment will use 3D clinical imaging technology, alongside subjective rating scales, to objectively assess and measure scar healing.

FS2 was first identified as a potential drug candidate for clinical research by investigators at the University of British Columbia. In pre-clinical trials, FS2 demonstrated the prevention of scars as well as the breakdown and reduction of existing scars that occurred after injury, surgery or disease, both externally and internally.

A pivotal moment

“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 program,” says Dr. Carlos Camozzi, BirchBioMed’s chief medical officer.

“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 the HHS represents the first of up to 10 clinical sites in Canada earmarked to undertake this research. The first patients were expected to enrol a few weeks ago, in September.

Lise Diebel works in communications at HHS.