Vicores C21 minskar långsiktiga lungskador efter COVID-19 i ATTRACT fas 2 uppföljningsstudien

2021-11-02 | Regulatorisk

· Resultaten visade närmare 50% minskning av uppkomna lungskador efter behandling med C21  jämfört med placebo
· Dessa positiva fynd tillsammans med tidigare kliniska resultat[1] talar för att C21 kan påskynda återhämtningen  
· C21 utvärderas för närvarande vid en fas 3-studie i COVID-19 patienter

Göteborg,  2 november, 2021 – Vicore Pharma Holding AB (publ) (“Vicore”), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag resultat att behandling med bolagets AT2R agonist, C21, minskar långsiktiga lungskador hos sjukhusinlagda COVID-19 patienter.

De nya resultaten är baserade på undersökningar med högupplöst datortomografi (HRCT) i  en uppföljningsstudie 3-6 månader efter avslutad behandling, ATTRACT-22. Studien inkluderade en undergrupp om totalt 33 patienter med COVID-19, som deltog i Vicores fas 2-studie ATTRACT3. De patienter som behandlades med C21 (n=17) uppvisade en minskning av patologiska lungförändringar jämfört med placebo (n=16); i C21-gruppen var i genomsnitt 10,3% av lungan påverkad jämfört med 19,2% i placebogruppen. Den dominerande radiologiska förändringen var s.k. ”ground glass opacity” en karaktäristisk lungförändring efter virala luftvägsinfektioner. Även om inga funktionella tester genomfördes i den här studien, är det välkänt att försämrat gasutbyte är en vanlig komplikation hos COVID-19 patienter med en onormal HRCT efter tre månader.

De här lovande resultaten är uppmuntrande nyheter för patienter och läkare som deltar i Vicores pågående fas 3-studie i COVID-19, ATTRACT-34 och tyder på att C21 har potential att påskynda återhämtningen efter COVID-19. De indikerar också att de långsiktiga skadorna som vissa patienter upplever efter svår COVID-19 kan komma att förbättras efter behandling med C21.” säger Elin Rosendahl, VP clinical development vid Vicore Pharma.

Lungskadorna utvärderades av en oberoende blindad radiolog med erfarenhet från utläsning av HRCT-undersökningar vid en nationell lungklinik i Storbritannien (UK). Graderingen av lungförändringarna utgjordes av den ackumulerade totalen av vedertagna lungskadetyper som vanligtvis bedöms av radiologer. HRCT-undersökningarna genomfördes vid uppföljningsbesök på de lokala sjukhusen 90-170 dagar efter 7-dagarsbehandlingen under ATTRACT-studien i vilken patienterna fick C21 eller placebo i tillägg till standardbehandling, inklusive steroider och det antivirala läkemedlet remdesivir. Så vitt vi vet är det här första gången långsiktiga effekter av läkemedel på lungskador efter COVID-19 har undersökts.

Resultaten från ATTRACT-studien publicerades nyligen i EClinicalMedicine, en expertgranskad vetenskaplig tidskrift publiserad av Lancet och tillgänglig via denna länk. Den randomiserade, dubbelblindade, placebokontrollerade studien visade att C21 i tillägg till standardbehandling väsentligt minskade antalet COVID-19 patienter som behövde syrgasbehandling, vilket indikerar snabbare återhämtning jämfört med placebo.

ATTRACT-3, pågående fas 3-studie i COVID-19 
Den pivotala fas 3-studien ATTRACT-3 blev godkänd av FDA i juni 2021 och genomförs i USA, Tjeckien, Ukraina, Indien, Sydafrika och Filippinerna. 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. Det här är en annan patientkategori än de som som erhåller antivirala läkemedel. 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 idiopatisk lungfibros (IPF)5 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  

Denna information är sådan som Vicore Pharma Holding AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersoners försorg, för offentliggörande den 2 november 2021 kl. 07:40 CET.

1. Resultat från fas 2-studie i COViD-19 (ATTRACT)
2. NCT04878913
3. NCT04452435
4. NCT04880642
5. NCT04533022

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