BirchBioMed reports breakthrough phase 2 trial results for FS2 in treating keloid scars

BirchBioMed, a Canadian clinical-stage immunology company, has unveiled promising results from a phase 2 trial of FS2, its pioneering antifibrotic therapy designed to treat keloid scars. The company’s treatment has shown significant advantages over traditional scar creams, including the market-leading Mederma, in a double-blind study. This phase 2 clinical trial, conducted with 75 patients, represents a major step forward in scar treatment, offering a new approach to managing one of the most challenging and disfiguring types of scars.

The trial assessed the effectiveness of FS2 in treating mature keloid scars, a condition that affects millions of people worldwide. According to BirchBioMed, the results of the study were striking, with FS2 demonstrating statistically significant improvements in scar reduction compared to both Mederma and a placebo vehicle. These findings were measured using the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS), which are widely recognized for evaluating scar severity and treatment outcomes.

At the conclusion of the 180-day trial, FS2 delivered measurable improvements in VSS scores, further reinforcing its potential as a groundbreaking treatment. The active ingredient in FS2 works at the molecular level to target the root cause of scar formation. By inhibiting the production of collagen and fibronectin, two proteins crucial to scar development, FS2 helps prevent the formation of new scars while simultaneously enhancing the breakdown of existing ones. Moreover, FS2 promotes the production of scar-degrading enzymes, MMP-1 and MMP-3, offering a dual mechanism of action that targets both the creation and persistence of scars.

BirchBioMed’s CEO, Mark S. Miller, expressed his enthusiasm over the results, noting that FS2 offers a safe and effective solution to a widespread problem that severely impacts many people’s lives. Miller pointed out that scarring is a growing therapeutic challenge, with the global cost of scar treatment projected to reach $41.8 billion by 2022. This reflects the increasing demand for effective solutions, especially as the U.S. National Institutes of Health reports that approximately 11 million Americans suffer from keloid scars.

With FS2’s promising phase 2 results, BirchBioMed is poised to make a significant impact on the scar treatment market. As the company prepares for the next steps in its clinical development, it is clear that FS2 has the potential to transform how keloid scars are treated, offering hope to millions who have long struggled with the physical and emotional toll of disfiguring scars.

In conclusion, BirchBioMed’s FS2 therapy is positioning itself as a groundbreaking solution in the field of scar treatment. The positive phase 2 trial results indicate that FS2 could become a key player in the fight against keloid scars, offering a much-needed alternative to current treatments. As the clinical trials progress, FS2’s role in transforming scar care will continue to attract attention from the medical and biopharmaceutical communities.