Vicores interimsanalys från IPF-studien utvald att presenteras som ”late breaker” vid ERS-kongressen

2022-08-17

  • AIR-studien är en öppen, multicenter, fas 2-studie i patienter med idiopatisk lungfibros (IPF)
  • Interimsresultat har visat en stabilisering av sjukdomen och ökning av lungkapaciteten vid 24 och 36 veckor
  • Muntlig presentation av professor Toby Maher den 4 september kl 15:00 CET

Göteborg, 17 augusti 2022 – Vicore Pharma Holding AB (publ) (”Vicore”), ett läkemedelsföretag i klinisk fas som utvecklar läkemedel riktade mot angiotensin II typ 2-receptorn (AT2R), meddelar idag att de tidigare publicerade interimsresultaten från AIR, en fas 2-studie i IPF kommer att presenteras som ”late breaker” den 4 september kl 15:00 vid European Respiratory Society (ERS)-kongressen i Barcelona, Spanien.

AIR-studien1 är en öppen fas 2-studie på obehandlade patienter med IPF som doserats med 100 mg C21 två gånger dagligen under 24 veckor med en möjlighet till förlängning i ytterligare 12 veckor. Studien genomförs i Storbritannien, Indien, Ukraina och Ryssland. IPF-diagnosen har fastställts centralt genom högupplöst datortomografi (HRCT). För att utvärdera lungfunktion används den erkända metoden för FVC*-mätningar, ERT-metoden, på samtliga kliniker. Tidigare i år meddelade Vicore lovande interimsresultat med en ökad lungkapacitet efter 24 till 36 veckors behandling med C21.  

Interimsresultaten visade att genomsnittlig FVC vid 24 veckor var +251 ml (n=9) över baslinjen (vid studiestart) jämfört med den förväntade -120 ml minskningen i en obehandlad population (en skillnad på 370 ml). Vid 36 veckor hade fem av sju patienter ökat sin lungkapacitet ytterligare medan två förblev stabila. C21 var säkert och väl tolererat. Fas 2-studien fortsätter att rekrytera patienter och parallellt förbereder bolaget för nästa studie i nära samarbete med regulatoriska och vetenskapliga experter.

“Graden av påverkan på FVC som sågs i interimsanalysen är mycket intressant med en ökad lungvolym över tid och om dessa resultat kan upprepas i en placebokontrollerad studie kommer C21 att skapa helt nya möjligheter inom IPF. ” säger professor Toby Maher, Keck School of Medicine vid University of Southern California,

Information om presentationen
ERS session: What is hot in interstitial lung diseases (swe: Senaste nytt inom interstitiella lungsjukdomar)
Titel: Late Breaking abstract – Interim results from AIR, an open-label, single arm, 36-week ph 2 trial of C21 in subjects with idiopathic pulmonary fibrosis
Presentatör: Professor Toby Maher
Referens: OA1397
Datum och tid: Söndag den 4 september kl 15:00 CET
Länk:
https://www.ersnet.org/congress-and-events/congress/

Om idiopatisk lungfibros (IPF)  
IPF är en svårt handikappande lungsjukdom med en prognos som är sämre än för de flesta cancerformer. Det finns två godkända behandlingar för IPF, Ofev® (nintedanib) registrerat varumärke av Boehringer Ingelheim och Esbriet® (pirfenidone) registrerat varumärke av Roche. Dessa minskar sjukdomens progression med upp till 50 procent, men med betydande biverkningar och med försämrad livskvalitet som följd.

Om angiotensin II typ 2-receptor agonister (ATRAGs)    
AT2R är en del av kroppens regenerering och reparationssystem och tros vara involverad i flera sjukdomar kopplade till hög ålder och cellernas åldrande inklusive idiopatisk lungfibros, kronisk njursjukdom, hjärtsvikt och kognitiva störningar. Att stimulera AT2R har visat sig vara effektivt i flera sjukdomsmodeller och den kliniska valideringen pågår vid akut och kronisk lungsjukdom. Stimulering av AT2R kan även vidga små artärer hos djur och människa för att lokalt öka blodflödet.

För ytterligare information, vänligen kontakta:
Carl-Johan Dalsgaard, VD
Telefon: +46 70 975 98 63
E-post: carl-johan.dalsgaard@vicorepharma.com

Informationen lämnades för offentliggörande den 17 augusti 2022 kl 08:00 CET.

1. NCT04533022

*Forced Vital Capacity, ett mått för att mäta lungfunktion

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