Lancets EClinicalMedicine publicerar resultat från fas 2-studie med C21 i COVID-19

2021-10-25

· Studien visade att C21 minskade behovet av syrgas- och respiratorbehandling, vilket indikerar en snabbare återhämtning. C21 var också säkert och väl tolererat.
· Resultaten låg till grund för Vicores beslut att gå vidare med en fas 3-studie vilken beräknas vara klar första halvåret 2022.

Göteborg, 25 oktober, 2021 – Vicore Pharma Holding AB (publ) (“Vicore”), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag att resultaten från fas 2-studien ATTRACT med angiotensin II typ 2 receptor agonisten C21 i COVID-19 har publicerats i EClinicalMedicine, en expertgranskad vetenskaplig tidskrift utgiven av The Lancet. Publikationen finns tillgänglig online via denna länk.

”De positiva resultaten från fas 2-studien är mycket uppmuntrande och ledde till att Vicore har fortsatt utvärderingen av C21 i den pågående fas 3-studien ATTRACT-3, säger Göran Tornling, senior rådgivare till Vicore och försteförfattare till ATTRACT-publikationen ”Vi är mycket glada över att kunna förmedla dessa viktiga resultat genom en publikation i EClinicalMedicine”.

Fas 2-studien ATTRACT1 planerades och genomfördes under 2020, mitt under det stora utbrottet av COVID-19. Även om det primära effektmåttet (minskning av CRP) inte skiljde sig mellan C21- och placebo-behandlade patienter efter sju dagars behandling, visade fördjupade analyser av resultaten att C21 kan minska det ökade behovet av syrgasbehandling. I denna studie omfattande 106 patienter tyder resultaten på att behandling med C21 kan ha minskat utvecklingen till en mer allvarligare respiratorisk sjukdom.

Vi ser ett fortsatt behov av effektiva behandlingar för sjukhusinlagda patienter med COVID-19.  Vaccinationsgraden är fortfarande låg med endast 37%* vaccinerade med två doser världen över och nya mutationer av viruset är ett kvarstående hot. Förutsatt att vi kan bekräfta de positiva resultaten från fas 3-studien så har C21 möjlighet att kunna bli en av dessa behandlingar utöver anti-viral terapi” säger Carl-Johan Dalsgaard, VD i Vicore och medförfattare till publikationen.

Ansvarig prövare för ATTRACT var Professor Joanna Porter, verksam inom lung- och allmänmedicin vid University College London Hospitals NHS Foundation Trust (UCL+H) och professor i lungmedicin vid UCL.

ATTRACT-3, pågående fas 3-studie i COVID-19 
Den pivotala fas 3-studien ATTRACT-32 blev godkänd av FDA i juni 2021 baserat på resultaten från fas 2-studien ATTRACT. ATTRACT-3 är en randomiserad, dubbelblind, placebokontrollerad, 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. ATTRACT-3 rekryterar nu patienter och s.k. top-line-resultat förväntas under det första halvåret 2022.

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) vilket leder till läkning av skadade vävnader. C21 utvärderas för närvarande i en fas 2-konceptstudie i IPF samt i en pivotal fas 3-studie i COVID-19.

Finansiering från LifeArc                         
ATTRACT-studien erhöll 1,5 miljoner GBP i finansiering från välgörenhetsorganisationen LifeArc – Coronavirus (COVID-19) Therapeutics fond om totalt 10 miljoner GBP som lanserades i mars 2020 för att stödja forskning och tester av läkemedel som snabbt kunde utvecklas för att adressera COVID-19.

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 25 oktober 2021 kl 08:00 CET.

* Our world in data

1. NCT04452435

2. NCT04880642

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