Amryt shares rise on success of 'EASE' trial
Biopharmaceutical company Amryt Pharma announced positive results from its pivotal phase 23 ‘EASE’ trial of ‘Filsuvez’, or ‘Oleogel-S10’, previously ‘AP101’, on Thursday.
The AIM-traded firm said the primary endpoint of the trial was met with statistical significance, adding that the proportion of patients with first complete closure of the epidermolysis bullosa (EB) target wound within 45 days was 41.3% in the Oleogel-S10 group, and 28.9% in the control group.
It said that translated to a 44% increase in the probability of target wound closure with Oleogel-S10, compared to the control gel.
The proportion of recessive dystrophic EB (RDEB) patients with first complete closure of the EB target wound within 45 days was 44.0% in the Oleogel-S10 group, and 26.2% in the control group, which translated to a 72% increase in the probability of target wound closure with Oleogel-S10 compared to the control gel in RDEB patients.
A greater reduction in pain associated with dressing changes was observed in the Oleogel-S10 treatment group at each time point, compared with the control group, the board added.
It said that at day 14, that difference was nominally significant.
There was also a greater reduction in total body wound burden as measured by EB disease activity and scarring index (EBDASI) and total body surface area of EB partial thickness wounds with Oleogel-S10, although the differences were not statistically significant.
Amryt said Oleogel-S10 had an “acceptable” safety profile, and was well-tolerated when compared with the control gel.
“Today’s announcement of the positive data from EASE marks another significant milestone for Amryt as we seek approval for Filsuvez,” said chief executive officer Dr Joe Wiley.
“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.”
At 1539 GMT, shares in Amryt Pharma Holdings were up 4.52% at 208p.