BirchBioMed will begin reviewing CRO pitches for a Phase III trial of FS2 for topical scarring in approximately two months, CEO Mark Miller said. The trial is expected to start within six months, although upcoming regulatory discussions and ongoing partnership discussions add some uncertainty to the timelines, Miller explained.
The King City, Canada-based BirchBioMed seeks a CRO with experience in dermatology and plastic surgery, Miller said, adding it will be tasked with managing the trial and ensuring documentation of results. Although the exact trial locations are not yet finalised, there is strong tax incentive to conduct the trial in Canada, Miller explained. BirchBioMed is also considering sites in the US, particularly Florida and Michigan where it has ties to universities, he added.
The Phase III trial will likely be similar in structure to a recently completed 75-patient Phase II trial of restorative wound care cream on surgical excisions. This study used the Vancouver Scar Scale (VSS) and Patient and Observer Scar Assessment Scale (POSAS) as endpoints compared to the standard of care, Mederma (cepalin), which is manufactured by Frankfurt, Germany-based Merz Pharmaceuticals, Miller said. However, the Phase III will likely enrol 150–200 patients or more, depending on regulatory discussions, he explained.
In the Phase II trial, FS2 demonstrated a statistically significant improvement in VSS score compared to Mederma (p<0.001) and vehicle (p<0.05) after 180 days, according to a 22 January company press release. There was also a 51% improvement in POSAS with FS2 compared to 28% for Mederma and 20% for vehicle.
Meanwhile, a Phase II trial of FS2 for scar prevention has enrolled five out of an expected 50 patients using a CRO, Miller said, declining to name it. Covid-19 surges have led to multiple recruitment delays, and 4Q21 results are a more realistic bet than 3Q21 as the company had originally predicted, he added. Although the trial is currently recruiting out of the University of British Columbia, BirchBioMed is considering additional sites to speed recruitment, Miller said. The company is in active discussion with an undisclosed number of Canadian sites and is contemplating adding a site in the US as well, he explained.
FS2 prevents or reduces scarring by reducing the production of collagen and fibronectin, two primary extracellular scar-forming proteins, at the molecular level, as well as by increasing the production of scar-degrading enzymes, according to the company website.
William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.