Amryt Declares Constructive Interim Evaluation Information From Open Label Section of EASE Section 3 Trial in EB

Article content material

Amryt Declares Constructive Interim Evaluation Information From Open Label Section of EASE Section 3 Trial in EB

Late-breaking oral presentation on the American Academy of Dermatology Annual assembly 2022

Physique floor space share of partial thickness wounds diminished from 12.1% to five.4% after at the least 15 months of therapy with Oleogel-S10  

 No new security alerts noticed

DUBLIN, Eire, and Boston MA, March 26, 2022, Amryt (Nasdaq: AMYT), a worldwide, commercial-stage biopharmaceutical firm devoted to buying, creating and commercializing novel therapies for uncommon ailments, right now introduced new constructive medical knowledge from EASE, the most important Section 3 trial in Epidermolysis Bullosa (EB).  These knowledge have been introduced throughout a late-breaking oral presentation on the American Academy of Dermatology (AAD) Annual Assembly 2022 held in Boston, MA.  Professor Dedee Murrell, M.D. (Chair, Division of Dermatology, St George Hospital, UNSW, Sydney, Australia) was the presenting writer of the 12-month interim evaluation of the two-year open-label section (OLP) (n=205) from the EASE trial evaluating the protection and efficacy of Oleogel-S10 in sufferers with EB.

Article content material

Highlights

Article content material

Dr Mark Sumeray, Chief Medical Officer, commented: “We’re happy to current new constructive knowledge from the EASE trial.  These essential long-term interim security and efficacy knowledge exhibit a median 55% discount within the physique floor space share with partial thickness wounds in these sufferers who continued on Oleogel-S10 for at the least 15 months of therapy, which builds on the beforehand reported constructive knowledge from the DBP of EASE.  We stay dedicated to our purpose of delivering a clinically accredited therapy to sufferers in want.” 

Professor Dedee Murrell, M.D., added “This new evaluation reinforces the medical profit the place sufferers had sustained enchancment regardless of ongoing growth of the systemic illness in EB.  This builds on the information from the double-blind section the place the first endpoint was met, whereby Oleogel-S10 demonstrated accelerated wound therapeutic in sufferers. The 12-month interim evaluation of the OLP of EASE offers encouraging knowledge on the long-term profit for EB sufferers, for whom there aren’t any at present accredited therapy choices.”

Article content material

About Epidermolysis Bullosa
Epidermolysis Bullosa (EB) is a uncommon and devastating group of hereditary issues of the pores and skin, mucous membranes, and inside epithelial linings characterised by excessive pores and skin fragility and blister growth.  Sufferers with extreme types of EB endure from extreme, continual blistering, ulceration and scarring of the pores and skin, mutilating scarring of the arms and toes, joint contractures, strictures of the esophagus and mucous membranes, a excessive threat of creating aggressive squamous cell carcinomas, infections and threat of untimely loss of life.  The worldwide market alternative for EB is estimated by the Firm to be in extra of $1.0 billion.

About EASE
The EASE trial (NCT03068780) is the most important ever world Section 3 trial carried out in sufferers with EB, carried out throughout 58 websites in 28 international locations. It includes a 3-month double-blind randomised managed section adopted by a 24-month open-label, single-arm section. Sufferers with dystrophic and junctional EB goal wounds of between 10 and 50cm² in dimension that have been current for > 21 days and < 9 months have been randomized within the double-blind section to review therapy in a 1:1 ratio and wound dressings utilized based on normal of care.  223 sufferers have been enrolled into the trial together with 156 pediatric sufferers.  Of people who accomplished the double-blind section, 100% entered the open label security observe up section.

Article content material

About Amryt

Amryt is a worldwide commercial-stage biopharmaceutical firm centered on buying, creating and commercializing revolutionary therapies to assist enhance the lives of sufferers with uncommon and orphan ailments.  Amryt includes a robust and rising portfolio of economic and growth property.  

Amryt’s business enterprise includes three orphan illness merchandise – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®).

Myalept®/Myalepta® (metreleptin) is accredited within the US (beneath the commerce identify Myalept®) as an adjunct to weight loss plan as alternative remedy to deal with the problems of leptin deficiency in sufferers with congenital or acquired generalized lipodystrophy (GL) and within the EU (beneath the commerce identify Myalepta®) as an adjunct to weight loss plan for the therapy of leptin deficiency in sufferers with congenital or acquired GL in adults and kids two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and kids 12 years of age and above for whom normal therapies have failed to attain enough metabolic management.  For extra info, please observe this hyperlink.

Article content material

Mycapssa® (octreotide capsules) is accredited within the US for long-term upkeep remedy in acromegaly sufferers who’ve responded to and tolerated therapy with octreotide or lanreotide.  Mycapssa® is the primary and solely oral somatostatin analog accredited by the FDA.  Mycapssa® has additionally been submitted to the EMA and isn’t but accredited in Europe.  For extra info, please observe this hyperlink.

Juxtapid®/Lojuxta® (lomitapide) is accredited as an adjunct to a low-fat weight loss plan and different lipid-lowering medicinal merchandise for adults with the uncommon ldl cholesterol dysfunction, Homozygous Familial Hypercholesterolaemia (“HoFH”) within the US, Canada, Colombia, Argentina and Japan (beneath the commerce identify Juxtapid®) and within the EU, Israel, Saudi Arabia and Brazil (beneath the commerce identify Lojuxta®).  For extra info, please observe this hyperlink.

Article content material

Amryt’s lead growth candidate, Oleogel-S10 is a possible therapy for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a uncommon and distressing genetic pores and skin dysfunction affecting younger kids and adults for which there’s at present no accredited therapy.  Filsuvez® has been chosen as the model identify for Oleogel-S10.  The product doesn’t at present have regulatory approval to deal with EB.

Amryt’s pre-clinical gene remedy candidate, AP103, provides a possible therapy for sufferers with Dystrophic EB, and the polymer-based supply platform has the potential to be developed for the therapy of different genetic issues.

Amryt additionally intends to develop oral drugs which can be at present solely accessible as injectable therapies by its Transient Permeability Enhancer (TPE^®) expertise platform.  For extra info on Amryt, together with merchandise, please go to www.amrytpharma.com.

Article content material

Ahead-Trying Statements
This announcement might include forward-looking statements and the phrases “anticipate”, “anticipate”, “intends”, “plan”, “estimate”, “purpose”, “forecast”, “mission” and comparable expressions (or their damaging) determine sure of those forward-looking statements. The forward-looking statements on this announcement are based mostly on quite a few assumptions and Amryt’s current and future enterprise methods and the surroundings during which Amryt expects to function sooner or later. Ahead-looking statements contain inherent identified and unknown dangers, uncertainties and contingencies as a result of they relate to occasions and depend upon circumstances that will or might not happen sooner or later and will trigger the precise outcomes, efficiency or achievements to be materially totally different from these expressed or implied by such forward-looking statements. These statements aren’t ensures of future efficiency or the power to determine and consummate investments. Many of those dangers and uncertainties relate to components which can be past Amryt’s capacity to manage or estimate exactly, equivalent to future market circumstances, the course of the COVID-19 pandemic, forex fluctuations, the behaviour of different market individuals, the end result of medical trials, the actions of regulators and different components equivalent to Amryt’s capacity to acquire financing, adjustments within the political, social and regulatory framework during which Amryt operates or in financial, technological or shopper traits or circumstances. Previous efficiency shouldn’t be taken as a sign or assure of future outcomes, and no illustration or guarantee, specific or implied, is made concerning future efficiency. No particular person is beneath any obligation to replace or preserve present the knowledge contained on this announcement or to offer the recipient of it with entry to any extra related info that will come up in reference to it. Such forward-looking statements replicate the Firm’s present beliefs and assumptions and are based mostly on info at present accessible to administration.

Investor Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com
Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com

Media Contact
Patrick Bursey, LifeSci Communications, +1 (203) 430 9545, pbursey@lifescicomms.com