Vicores digitala terapi inom IPF uppvisar nära 50% minskad ångest i pilotstudie

2022-10-06

  • Utvärdering avseende säkerhet, funktionalitet och användarvänlighet utföll positivt
  • Rapporterad minskning av ångest för patienter med lungfibros
  • Pivotal studie i 250 patienter med lungfibros, COMPANION, planeras starta under fjärde kvartalet 2022

Göteborg, 6 oktober, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”) pionjärer inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), tillkännager idag positiva resultat från pilotfasen av COMPANION-studien. Vicores digitala kognitiva beteendeterapi, AlmeeTM för patienter med lungfibros var säker, funktionell, användarvänlig och minskade rapporterade ångestsymptom med 49% hos patienter med idiopatisk lungfibros (IPF).

Pilotfasen av COMPANION1 var en fyra veckor lång, öppen och decentraliserad klinisk studie på 10 patienter med självrapporterad ångest i samband med IPF. Det primära målet med studien, test av funktionalitet, användarupplevelse och säkerhet, uppnåddes och det preliminära effektresultatet var uppmuntrande; fyra veckors användning minskade patientrapporterad ångest med 4,2 punkter enligt GAD-7* skalan. En minskning på GAD-7 skalan med mer än ?2 punkter anses vara kliniskt relevant.

Dessa resultat indikerar att Vicores digitala terapi (DTx) kan komma att bli en säker och tillförlitlig resurs för IPF-patienter i att hantera den psykologiska bördan av att leva med en svår sjukdom.  

"Givet den höga incidensen av ångest hos IPF-patienter och dess potentiella effekt på livskvaliten är dessa resultat uppmuntrande. Forskningen av ångestterapi vid lungfibros är bristfällig och dessa resultat är ett stort steg framåt i arbetet med att förbättra livskvaliten hos patienter med lungfibros.” säger Maureen Horton, huvudprövare för COMPANION-studien, tidigare Professor i Medicine vid Division of Pulmonary and Critical Care Medicine på Johns Hopkins University School of Medicine och Co-Director vid Johns Hopkins Interstitial Lung Disease Clinic.

Den pivotala fasen av COMPANION kommer genomföras med en fullt implementerad DTx, AlmeeTM, och beräknas starta under det fjärde kvartalet 2022. Studien är en nio veckor lång, randomiserad, kontrollerad och decentraliserad studie i 250 patienter med olika typer av lungfibros. ”Top-line-resultat” från studien beräknas rapporteras under 2023.

“Detta är den första kliniska studien med vår DTx, utvecklad i samarbete med Alex Therapeutics. Vi är mycket glada över resultaten och har samlat in information som är värdefull inte bara för den pivotala studien, utan även för våra andra kliniska studier med C21 i IPF .” säger Jessica Shull, Head of Digital Therapeutics på 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 6 oktober 2022 kl 08:00 CET.

1. NCT05330312

Kort om digitala terapier (DTx)       
DTx är en kliniskt utvärderad mjukvara, designad, byggd och testad för att behandla en sjukdom eller ett tillstånd. DTx klassas som medicintekniska produkter och omfattas av förordningar om medicintekniska produkter i de länder som de saluförs. DTx-produkter kan vara en fristående programvara eller användas tillsammans med annan terapi. På grund av det stora intresset för DTx hos läkemedelsföretag och medicinsk personal har myndigheter i Europa och andra länder utvecklat nya bedömningsmatriser för att säkerställa att digitala läkemedel är kliniskt säkra och effektiva innan de godkänns av regulatoriska myndigheter.

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. AlmeeTM kommer att utvärderas genom pilotstudier och kliniska prövningar samt vara föremål för regulatoriska godkännanden, enligt nationella och internationella standarder för utveckling av medicintekniska produkter.

*Om GAD-7          
GAD-7 är en självadministrerad patientenkät som används som ett screeningverktyg och svårighetsmått för generaliserat ångestsyndrom (GAD). Spitzer RL, Kroenke K, Williams JB, et al; A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

Om Alex Therapeutics AB 
Alex Therapeutics skapar och licensierar Digitala Terapier (DTx) genom samarbeten med läkemedelsföretag. Den beprövade "Alex DTx-plattformen", expertis inom patientcentrerad design och evidensbaserad psykologi gör Alex Therapeutics unikt positionerat på den globala marknaden för att leverera säkra och effektiva DTx, Sofware-as-a-Medical-Device (SaMDs). Företaget har behandlat tiotusentals patienter, har kliniskt validerade produkter, samt överväldigande positiva patient- och partner rekommendationer. För mer information, besök www.alextherapeutics.com.

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Vicore Pharma Holding AB (“Vicore”) shall only process personal data in accordance with applicable data protection law and high industry standards.

 

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