Filsuvez Significantly Reduces Wounds After 15 Months in Trial
People with dystrophic epidermolysis bullosa (DEB) saw the total surface of their wounds significantly reduced after being treated with Filsuvez (Oleogel-S10) for more than a year, new data from the EASE clinical trial show.
After 15 months, these patients experienced sustained reductions of 53%, on average, in wound burden from the study’s start.
The findings were presented at the 2022 Society for Pediatric Dermatology (SPD) annual meeting, being held July 7–10 in Indianapolis, Indiana.
“We are pleased to present new clinical analyses that support [Filsuvez] as a potential treatment for DEB patients living with this debilitating subtype of EB,” Tracy Cunningham, MD, chief medical officer at Amryt Pharma, which is developing the treatment, said in a press release.
Filsuvez is a topical gel containing compounds extracted from the bark of the birch tree. The Phase 3 EASE clinical trial (NCT03068780) enrolled more than 200 adults and children with DEB or other forms of epidermolysis bullosa, making it the largest trial conducted in EB, according to Amryt.
For the first 90 days of EASE, the participants were randomly assigned to receive Filsuvez or an inactive control gel. Then, all participants had the option to enter an open-label extension study to be treated with Filsuvez for up to two years.
At the SPD meeting, researchers presented new data that focused on the subset of EASE participants with DEB.
In the initial portion of the study, significantly more DEB participants given Filsuvez had target wound closure closure within 45 days (44.3% vs. 29.6% of those who received the placebo gel).
Filsuvez also outperformed the placebo at reducing wound burden, as measured by body surface area percentage (BSAP). After 90 days, the average decrease was 4.4 percentage points with Filsuvez compared to 2.4 percentage points with the placebo.
Throughout the initial 90-day treatment period, fewer participants given Filsuvez required daily wound dressing changes (32% vs. 50% of those on the placebo). Patients treated with Filsuvez also reported reduced pain when dressings were changed.
“It is encouraging to see the positive impact that [Filsuvez] has on patients and their families including accelerated wound healing and less pain during dressing changes,” Anna Bruckner, MD, of the University of Colorado School of Medicine, who presented data at the SPD meeting. “We know that these factors are meaningful to patients during their daily routine living with EB.”
“These new analyses further support [Filsuvez]’s clinical benefit as a well-tolerated and effective therapy for patients with DEB in line with what has been seen in the EASE primary analysis,” she added.
Wound infections were generally infrequent for the patients on DEB, and were mostly mild for those treated with Filsuvez.
Data from the open-label extension of EASE showed that, after 15 months on Filsuvez, patients experienced sustained reductions in wound burden, with BSAP decreasing by 53% on average from the beginning of the study.
Additionally, average scores on the Epidermolysis Bullosa Disease Activity and Scarring Index, a measure of disease activity, decreased from 19.9 at the study’s start to 14.8 after 15 months of treatment. No new safety signals related to Filsuvez have been identified in the extension study.
Filsuvez was recently approved for DEB and junctional epidermolysis bullosa in the European Union, based largely on data from the EASE trial. However, the U.S. Food and Drug Administration (FDA) rejected an application seeking approval in the U.S., citing a need for more evidence of efficacy.
“These analyses follow an exciting time for patients and their families in the EU who, as a result of the European Commission decision to approve Filsuvez in the EU, finally have an approved treatment option available,” Cunningham said. “We are committed to working with other regulatory agencies, including the FDA, to enable more patients to avail of this treatment.”