Vicore meddelar att den första patienten inkluderats i COMPANION; en pivotal studie av en digital terapi för patienter med lungfibros

2022-12-05

  • Den första randomiserade kliniska studien med en digital terapi (DTx) för att hantera de psykologiska konsekvenserna av att leva med lungfibros
  • Första patienten inkluderad i den pivotala studien som genomförs i USA. Resultat från studien förväntas under fjärde kvartalet 2023
  • Stödjer utvecklingen av en produktportfölj med ett uttalat helhetsperspektiv inom ovanliga lungsjukdomar

Stockholm, 5 december, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”), ledande inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), meddelar att bolaget lanserat den pivotala fasen av COMPANION, den första kliniska studien av en digital kognitiv beteende terapi (dKBT) för patienter med lungfibros.

Lungfibros är en allvarlig sjukdom med dålig prognos där symptom som dyspné, trötthet och hosta gradvis försämras. I en föregående studie visades att 63% av patienter med lungfibros rapporterar behandlingsbara nivåer av ångest1. Fördelen med en digital terapi är att den är tillgänglig dygnet runt och kan individanpassas för att passa patientens behov och schema.  

"Kontinuerlig tillgång är viktigt när man ger psykologiskt stöd till patienter som är oroliga över att lämna sina hem på grund av risken för infektion eller begränsningar på grund av sin sjukdom," säger Dr. Josh Solomon, National Jewish Health, Denver Colorado och klinisk prövare för studien.

COMPANION-studien2 är en fullt digitaliserad, randomiserad, parallellgruppskontrollerad klinisk studie för att utvärdera den digitala terapin, Almee™ avseende den psykologiska symptombördan hos vuxna diagnosticerade med lungfibros. Patienter som inkluderas i studien kommer att randomiseras till Almee™ alternativt standardbehandling, vilken tjänar som kontrollgrupp, under en period om nio veckor. Nivåer av ångest rapporteras av patienter och studieläkare via validerade frågeformulär.

COMPANION-studien kommer inkludera 250 patienter i USA och förväntas slutföras under det fjärde kvartalet 2023. Förutsatt att resultatet är positivt kommer en ansökan om godkännande för Almee™ som en medicinteknisk produkt hos FDA (U.S. Food and Drug Administration) lämnas in med efterföljande lansering under 2024. Målet med Almee ™ är att att behandla de ångestsymptom som orsakas av att leva med lungfibros.

“Almee™ är en integrerad del av Vicores utvecklingsstrategi kring holistiska och individanpassade behandlingar för ovanliga lungsjukdomar och tar hand om ett behov hos patienter med lungfibros som ingen tidigare fokuserat på. Denna decentraliserade kliniska undersökning ger också en möjlighet att tänka om vad gäller den traditionella modellen för kliniska prövningar i syfte att ha patienten i fokus.” säger Jessica Shull, Director of Digital Therapeutics hos Vicore.

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 5 december, 2022 kl 08:15 CET.

1. Vicore data on file

2. NCT05330312

Kort om AlmeeTM, Vicores digitala terapi inom lungfibros   
AlmeeTM (en medicinteknisk produkt under utveckling i väntan på FDA-godkännande) är en digital terapi (DTx) baserad på kognitiv beteendeterapi (KBT) för att adressera den psykologiska påverkan patienter med lungfibros upplever.  Vicore samarbetar med Alex Therapeutics för utvecklingen av denna medicintekniska produkt.

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