Amryt Pharma (AIM: AMYT ), the commercial-stage biopharmaceutical company, has announced positive results from its pivotal Phase 3 EASE trial of FILSUVEZ® (Oleogel-S10). 

EASE, which is the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), was performed across 58 sites in 28 countries.   

The trial, which demonstrated the effectiveness of FILSUVEZ® in accelerating wound healing in people with EB, was described by Amryt as “a very important milestone”. The group is seeking to approve FILSUVEZ® as a treatment for EB, for which there are currently none.  

Top-line results from its successful Phase 3 EASE trial of FILSUVEZ® will be presented at the European Association of Dermatology and Venereology Virtual Congress this weekend. 

The primary endpoint of the trial was met with ‘statistical significance’ with 41.3% of the Oleogel-S10 group seeing complete closure of EB target wound within 45 days - a 44% increase in the probability of target wound closure compared to the control gel group. 

Meanwhile, 44% of patients in the Oleogel-S10 group with Recessive Dystrophic EB (“RDEB”), the most severe EB, saw first complete closure of EB target wound within 45 days. 

Compared to 26.2% in the control group, this translates to a 72% increase in the probability of target wound closure with Oleogel-S10 compared to the control gel in RDEB patients. 

In wounds that achieved closure over the 90 day treatment period, the mean time to first closure in the Oleogel-S10 group was 37.7 days compared to 44.5 days in the control group. 

The proportion of completely closed target wounds within the 90 day treatment period was 50.5% in the Oleogel-S10 group compared with 43.9% in the control group (p value=0.296).  

In addition, a greater reduction in pain associated with dressing changes was also observed in the Oleogel-S10 treatment group at each time point compared with the control group.  

“Today’s announcement of the positive data from EASE marks another significant milestone for Amryt as we seek approval for FILSUVEZ®,” said Dr Joe Wiley, CEO of Amryt Pharma. 

He added, “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.” 

Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®. 

US FDA fast track status is intended to expedite the development of investigational medications and open the treatment to priority review should it come up for approval.  

The group said it also intends to pursue an accelerated assessment in the EU. Meanwhile, regulatory submissions in the US and EU are expected to be filed by late Q1 2021.  

Shares in Amryt Pharma have increased over 25% since early September 2020 to open 1.51% higher this morning at 202p following the announcement. 

Reasons to Follow AMYT 

Amryt is a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases with the company comprising a strong and growing portfolio of commercial and development assets. 

Its portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. 

In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion. 

Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®. 

Juxtapid®/ Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®. 

Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®. 

The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU. 

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