BirchBioMed has reported positive results from a phase 2 trial evaluating the use of topical FS2, the company’s antifibrotic platform therapy, in the treatment of keloid scars.
The Canadian clinical-stage immunology company said that the double-blind study delivered statistically significant results compared to Mederma, a market leading scar cream and a vehicle (placebo cream) in the treatment of mature keloids in 75 patients.
The participants in the mid-stage trial were assessed using the Vancouver Scar Scale (VSS) and also the Patient and Observer Scar Assessment Scale (POSAS).
BirchBioMed said that the change in percentage in VSS scores for FS2 showed a statistically significant improvement in comparison to Mederma and versus vehicle at the completion of the 180-day trial.
The Canadian immunology company said that FS2, which is the active ingredient in the company’s FS2 cream has demonstrated to prevent the formation of collagen, which is the key component of scars.
According to BirchBioMed, FS2 works at the molecular level by lowering the production of collagen and fibronectin, which are two main extracellular scar-forming proteins. Besides, FS2 is said to boost the production of key scar-degrading enzymes – MMP-1 and MMP-3 to inhibit the formation of scars and encourage the breakdown of existing scars.
Mark S. Miller – CEO of BirchBioMed said: “We are delighted with the results of FS2 in providing a safe and effective treatment for disfiguring scars that often profoundly affect a patient’s quality of life.
“Scarring poses a chronic and growing therapeutic challenge for millions of patients each year. The global cost of treating scars is expected to reach $41.8 billion in 2022, compared with $21.4 billion just three years ago.
“Moreover, the U.S. National Institutes of Health estimates that 11 million Americans suffer from keloid scars, making it all the more critical that we develop cost-effective and successful treatments.”