Vicore har erhållit godkännande från FDA för att starta en pivotal fas 3-studie med C21 i COVID-19

2021-06-11

Göteborg, 11 juni, 2021 – Vicore Pharma Holding AB (publ) (“Vicore”) ett särläkemedelsbolag som utvecklar innovativa läkemedel mot fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag att amerikanska U.S. Food and Drug Administration (FDA) har godkänt dess Investigational New Drug (IND)-ansökan för bolagets läkemedelskandidat och oralt tillgängliga angiotensin II type 2 receptor (AT2R) agonist, C21, för behandling av COVID-19. En aktiv IND gör det möjligt att påbörja bolagets pivotala fas 3-studie, ATTRACT-3, i USA.

ATTRACT-3-studien är en randomiserad, dubbelblind, placebo-kontrollerad, multinationell, fas 3-studie på 600 sjukhusinlagda vuxna patienter med COVID-19 som är i behov av syrgas men ej respirator. Studiens huvudsyfte är att utvärdera effekten av C21 avseende återhämtning från COVID-19. Vicores fas 2-studie i COVID-19 (ATTRACT) visade att C21 signifikant minskade behovet av kompletterande syrgasbehandling, vilket indikerade ett snabbare tillfrisknande vid behandling med C21 jämfört med placebo.

I ATTRACT-3 kommer patienterna att erhålla antingen 100 mg C21 eller placebo två gånger dagligen under 14 dagar som tillägg till standardbehandling och patienterna följs upp under 60 dagar. Förberedelser för att starta studien pågår nu i utvalda länder i Nord-, Syd- och Centralamerika, Europa, Afrika och Asien. S.k. top-line resultat från ATTRACT-3 förväntas under det första kvartalet 2022.  

“Sjukligheten och dödligheten i COVID-19 är fortfarande betydande, särskilt vid måttlig till allvarlig sjukdom, och vår tidigare studie indikerade att C21 har potential att förbättra andningsförmågan och främja återhämtningen hos dessa patienter” säger Carl-Johan Dalsgaard, VD i Vicore. “FDAs godkännande av vår första IND med C21 representerar en viktig milstolpe i förberedelserna för vår globala fas 3-studie.”

C21 i COVID-19 – förbättrar andningsförmågan                     
Resultaten från fas 2-studien på 106 sjukhusinlagda patienter med COVID-19 visade en signifikant minskad risk för behovet av kompletterande syrgasbehandling (90% jämfört med placebo vid dag 14; p=0,003), färre dödsfall och minskat behov av respiratorvård.

C21, första substansen i sin klass AT2R-agonister                
C21, den första substansen i sin klass av typen orala småmolekylära angiotensin II typ 2 receptor (AT2R) agonister, aktiverar den skyddande delen av renin-angiotensinsystemet (RAS). C21 har visat robusta effekter i human IPF-drabbad lungvävnad och en fas 2-studie i IPF-patienter pågår för närvarande. Mot bakgrund av att AT2R-aktivering har potential i ett antal ytterligare indikationer med betydande medicinska behov har Vicore intensifierat arbetet med att utveckla uppföljningsmolekyler med differentierade profiler.

För ytterligare information, vänligen kontakta:
Carl-Johan Dalsgaard, VD
Telefon: 070 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com  

Informationen lämnades för offentliggörande den 11 juni 2021 kl 08:00 CET.

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