FILSUVEZ, also known as Oleogel-S10, or previously AP101, was shown to lessen the healing time of wounds in people with epidermolysis bullosa (EB), where the skin is fragile to even the slightest touch.
The latest, more detailed batch of data reveals the proportion of patients with first complete closure of the EB target wound within 45 days was 41.3% in those receiving FILSUVEZ compared with 28.9% in the control group.
This translates to a 44% increase in the probability of target wound closure using the Amryt gel compared to the control.
The proportion of recessive dystrophic EB (RDEB) patients with first complete closure of EB target wounds within 45 days was 44% among those receiving the treatment, compared with 26.2% in the control group.
This translates to a 72% increase in the probability of target wound closure using FILSUVEZ compared with the control gel in RDEB patients.
Researchers also detected a greater reduction in pain associated with dressing changes in those receiving the medication. At day 14, this difference was “nominally significant”, Amryt said.
There was a greater reduction in total body wound burden as measured and total body surface area of EB partial-thickness wounds, although the differences were not statistically significant, it added.
“Today’s announcement of the positive data from EASE marks another significant milestone for Amryt as we seek approval for FILSUVEZ,” said Amryt chief executive, Dr Joe Wiley in a statement.
“These results also represent a potentially important advancement for patients and families living with this rare and distressing disorder. Our existing commercial business is performing and growing and if FILSUVEZ is approved, we already have the capacity, infrastructure and resources in place to commercialize FILSUVEZ and our plans for full launch are well advanced.”
The additional data will be shared with the European Association of Dermatology and Venereology Virtual Congress on October 31, and a virtual analyst and investor event on November 3.
For more details on both click here.