Filsuvez, a topical gel by Amryt Pharma, raises the probability of complete wound closure while reducing the time that wounds take to heal in people with epidermolysis bullosa (EB), new data from a Phase 3 clinical trial show.
Investigators found a statistically significant 41.3% of patients treated Filsuvez had first complete closure of a target wound within 45 days, compared with 28.9% of those given a placebo gel, details that support the company’s recent announcement of the study meeting its primary goal.
Data from the ongoing Phase 3 EASE trial (NCT03068780) were delivered as an oral presentation at the 29th European Association of Dermatology and Venereology (EADV) Virtual Congress, by Dedee Murrell, MD, chair of the Department of Dermatology at St. George Hospital in Sydney, Australia.
“Today’s announcement of the positive data from EASE marks another significant milestone for Amryt as we seek approval for Filsuvez,” Joe Wiley, MD, Amryt’s CEO, said in a press release. “We look forward to working with regulatory authorities to potentially make Filsuvez available as the first approved treatment for EB patients.”
Previously called Oleogel-S10, Filsuvez is a topical gel containing birch bark extract. The betulin found in this extract promotes wound healing by activating skin cells and certain pro-inflammatory molecules.
These newly released data found Filsuvez-treated patients were 44% more likely to experience target wound closure within 45 days than those receiving a placebo (control group).
In the RDEB group, treatment translated to a 72% increase in the probability of wound closure within 45 days (44% of RDEB patients vs. 26.2% of controls).
Secondary goals included wounds completely closed within 90 days (three months) with treatment. Here, the mean time to first closure was 37.7 days in the Filsuvez group, and 44.5 days in the control group. The proportion of completely closed wounds within three months was 50.5% in the Filsuvez group and 43.9% among those on a placebo, which was not statistically different. Likewise, time to wound healing over this 90-day period was not significantly different.
People using Filsuvez reported a greater reduction in pain during dressing changes, with was statistically significant at day 14 and showed a trend toward a significant benefit at three months.
Filsuvez patients also reported greater reductions in total body wound burden (measured with the EB Disease Activity and Scarring Index) and total body surface area of EB partial thickness wounds, although these differences were not significant.
Filsuvez was safe and well tolerated. The most frequently reported side effects were wound complications (61.5% of those on Filsuvez vs. 53.5% on placebo), fever (8.3% vs. 13.2%), wound infection (7.3% vs. 8.8%), itching (7.3% vs. 5.3%), and anemia (7.3% vs 3.5%).
Infections in target wounds were reported as adverse events in five patients: one in the Filsuvez group, and four in the placebo group, including one considered a severe adverse event (the three others were deemed moderate). The single infection in the Filsuvez group was classified as mild.
Amryt is now planning to submit a new drug application requesting Filsuvez’s approval, with priority review, to the U.S. Food and Drug Administration (FDA), and to request an accelerated review in the EU.
The FDA previously granted Filsuvez fast track and rare pediatric disease designations, and it has orphan drug status in both the U.S. and Europe. All these designations provide regulatory incentives to speed and support its clinical development.
The company expects to file its approval requests in the U.S. and EU in the first half of 2021.
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