Amryt Pharma has been granted a US patent for its lead drug, Episalvan, a treatment for Epidermolysis Bullosa (EB). a rare, hereditary skin disorder.
The most serious cases lead to disfigurement and cause intense suffering.
Children with this disorder are frequently referred to as "Butterfly Children".
Episalvan has already shown faster healing for wounds and chronic wounds compared to standard care and Amryt (LON:AMYT) is now preparing a phase III trial for the drug's use in EB treatment.
Europe’s medicines agency granted Episalvan a patent for the treatment of all partial thickness wounds in January.
Amryt estimates that the global EB market is worth US$1.5bn per annum.
Joe Wiley, chief executive, said he hoped the phase III trial for the use of Episalvan in EB treatment would start in the first quarter of 2017.
A meeting of the US Food and Drug Administration is planned for early in the next quarter to establish the trial’s study protocol. A clinical research organisation has been identified to conduct the phase III study.
A US application has also been made for orphan designation for AP102, a treatment for excess growth hormone condition acromegaly, with a pre-clinical study to be completed in coming weeks.
Amryt, which reversed into oil and gas group Fastnet in April, has cash of €10.7mln and posted a loss of €4.1mln in the half year to June.