Global biopharmaceuticals company Amryt Pharma (AIM:AMYT) saw its shares shoot up over 50% during Wednesday trading, as it announced that its FILSUVEZ treatment had successfully passed phase three of the EASE trial.
As stated by Amryt Pharma, FILSUVEZ is designed to treat dystrophic and junctional Epidermolysis Bullosa (EB), which is a “rare, chronic and distressing genetic skin disorder that causes the skin layers and internal body linings to separate and affects infants, children and adults”.
The condition currently affected as many as 30,000 individuals in the US and more than 500,000 people worldwide, with an estimated incidence for EB being around 1 in 20,000. The company predicts that the marekt opportunity for EB treatments is in excess of $1 billion.
The EASE trial
The EASE trial is noted to be the largest trial conducted that focuses on patients with EB. It was performed across 58 sites in 28 countries, with 223 patients enrolled – including 156 pediatric patients.
In a double-blind test lasting 45 days, the efficacy of FILSUVEZ was measured versus a control gel. The company stated that within this period, its treatment achieved statistical significance, which represents the first ever successful phase three top line readout in EB. It is also the fourth time that the treatment has illustrated its capacity to accelerate wound-healing in a phase three trial.
Going forwards, the company will evaluate data from the trial and present its results at an upcoming scientific symposium. Amryt Pharma stated that it intends to complete the submission of its rolling New Drug Application to the US Food and Drug Association and request a priority review for FILSUVEZ.
Amryt Pharma reaction
Commenting on the news, company CEO Joe Wiley stated:
“This positive outcome of the Phase 3 EASE trial marks another significant milestone for Amryt as we seek approval for FILSUVEZ ® and represents a potentially important advancement for patients and families living with this rare and distressing disorder. If approved, we intend to leverage our existing global infrastructure to commercialize FILSUVEZ.”
“We are proud to present these positive and encouraging results, demonstrating that FILSUVEZ could make an important difference to the lives of patients. We would like to extend our gratitude to all of the patients, their families, carers and physicians for their participation in the EASE trial and we look forward to working with regulatory authorities to make FILSUVEZ available as the first approved therapeutic treatment for EB patients. All of the team at Amryt are very excited by today’s news and the impact this may have in our efforts to help patients with this very distressing condition.”
Following the announcement, Amryt Pharma shares rallied by 51.25% or 82.00p, to 242.00p per share 09/09/20 12:00 GMT. This price is far-and-away a new record for the company’s shares, and far ahead of its year-to-date nadir of 90.00p a share.
The company’s p/e ratio is -1.80, earnings per share currently stand at -86.00p.