U.S. FDA GRANTS BIRCHBIOMED ORPHAN DRUG DESIGNATION FOR FS2 IN THE TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
VANCOUVER, BC, Dec. 2, 2025 /PRNewswire/ - BirchBioMed Inc., a leading clinical stage biopharmaceutical company, expert in the development of products for scarring and other fibrosis-related disorders and autoimmune therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to FS2 (kynurenic acid) for the investigational treatment of idiopathic pulmonary fibrosis (IPF).
"Being granted Orphan Drug Designation by the FDA is a pivotal milestone in BirchBioMed's development of FS2 for the treatment of IPF, a debilitating and fatal disease that has no more than a 5-year life expectancy after diagnosis," said Mark S. Miller, Chairman and CEO of BirchBioMed, "The FDA's designation provides BirchBioMed with development and commercial capabilities to address this high, unmet medical need."
The FDA's ODD program is designed to incentivize and facilitate the development of investigational drugs / compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders such as IPF, that affect fewer than 200,000 people in the U.S. Idiopathic pulmonary fibrosis (IPF), a rare and serious chronic lung disease, results in scarring (fibrosis) of the lungs for an unknown reason. It is characterized by the thickening and stiffening of lung tissue surrounding the air sacs, or alveoli, in the lungs. Over time, these changes can cause permanent scarring in the lungs, making it progressively more difficult to breathe. There is currently no cure for IPF, which affects between 3 million to 5 million people worldwide.
Carlos Camozzi, Chief Medical Officer, BirchBioMed, said: "This ODD indicates the scientific value of FS2 in the investigational treatment of IPF and underscores the opportunity for IPF patients to participate in our clinical trials. BirchBioMed is seeking regulatory approval to begin clinical trials on the systemic use of FS2 for the treatment of organ fibrosis, beginning with IPF early next year. As experts in the development of products for scarring and other fibrosis-related disorders, we are laser focused on FS2's potential to transform the lives of people suffering from this severe, chronic, deteriorating, irreversible, life-threatening lung disease."
ODD provides benefits that include eligibility for market exclusivity for seven (7) years post approval, accelerated approval for orphan drugs that meet certain criteria, fast-tracking to market once early-stage evidence indicates efficacy, tax credits for qualified clinical testing, waiver or partial payment of FDA application and registration fees, and FDA protocol assistance.
About FS2
FS2 (kynurenic acid) was first identified as a potential drug candidate for clinical research by investigators at the University of British Columbia for the topical treatment of scars and for systemic treatment of organ fibrosis, including scarring in the lungs, liver, kidneys, and heart. 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. A subsequent Phase II randomized double-blind clinical trial comparing the safety and efficacy of topical FS2 cream demonstrated superior, statistically significant efficacy on mature keloid scars as compared not only to the vehicle control but to a market leading scar cream. FS2 is unique in its therapeutic category as it targets scarring on the molecular level.
About BirchBioMed Inc.
BirchBioMed Inc. 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 for two scientific, novel technologies, FS1 (kynurenine)/FS2 (kynurenic acid) and AI-001 (FS2+cell therapy). Following preclinical and early/mid-stage clinical studies and trials, BirchBioMed's technologies have shown potential for future medical breakthrough treatments addressing multiple life-threatening diseases and severe debilitating conditions.
SOURCE BirchBioMed Inc
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