BirchBioMed Receives Health Canada Green Light to Start the Last Stage of its Groundbreaking Clinical Program to Minimize Scarring From Burns

BirchBioMed recently announced the authorization from Health Canada to conduct its Phase 2/3 randomized clinical trial of a naturally based compound, FS2, at multiple centers of expertise throughout Canada.

FS2, a kynurenic acid product to be used as a topical cream, was first identified by investigators at the University of British Columbia as a potential drug candidate for clinical research. In preclinical 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. FS2 targets scarring on the molecular level, making it unique in its therapeutic category.

“Health Canada’s approval of our Phase 2/3 randomized clinical trial is an outstanding achievement that validates BirchBioMed’s vision to bring innovative, effective and safe therapeutic options to many millions of people suffering from disfiguring and often life-threatening scars every year,” said Mark Miller, BirchBioMed’s Chairman and Chief Executive Officer. “In this process, BirchBioMed selected SGS Nutrasource as our Contract Research Organization. An innovative leader in the biopharmaceutical world, SGS Nutrasource provides BirchBioMed with extensive commercial, clinical and regulatory expertise at this strategic pivotal point in our development.”

SGS Nutrasource will run the Phase 2/3 randomized study involving up to 10 clinical sites in Canada.

“We are delighted to have been chosen by sponsor BirchBioMed as their CRO partner,” says William Rowe, President and CEO at SGS Nutrasource. “We have been working together scaling this and other programs and are excited to support a Canadian company as it advances in this highly novel area of human healthcare.”

SGS Nutrasource is a leading nutraceutical and pharmaceutical life sciences company focused on helping clients commercialize health and wellness products. In addition to a unique offering of clinical trial management, strategic and regulatory support services along with a state-of-the-art clinical trial site, SGS Nutrasource offers a series of third-party natural ingredient product certification programs (NutraStrong, IFOS, IKOS, IAOS, IGEN, IPRO, and Radioactivity Tested & Certified).

BirchBioMed is a pioneering clinical stage biopharmaceutical company focused on developing novel, breakthrough treatments for organ fibrosis, scarring, skin disorders, and autoimmune diseases, including Type 1 Diabetes. It holds exclusive, worldwide, pharmaceutical licenses from the University of British Columbia (UBC) for two scientific, novel technologies, FS1 (kynurenine)/FS2 (kynurenic acid) and AI-001 (kynurenic acid in combination with antigen-presenting cell therapy). Following preclinical and early/mid-stage clinical trials, BirchBioMed’s technologies have shown paramount potential for future medical breakthrough treatments addressing multiple life-threatening diseases and severe debilitating conditions. For more information, visit https://www.birchbiomed.com.