Vicore Pharma, lämnar in ett ”Letter of Intent” gällande en myndighetsansökan för fas II-studie i patienter med COVID-19, SARS CoV-2-infektion

2020-03-31 | Regulatorisk

Göteborg, 31 mars 2020 – Vicore Pharma, som utvecklar innovativa läkemedel mot ovanliga lungsjukdomar, annonserar idag att bolaget lämnat in ett ”Letter of Intent” angående myndighetsansökan till den brittiska läkemedelsmyndigheten MHRA[1] för en fas II-studie med läkemedelskandidaten C21 i patienter med COVID-19, SARS CoV-2-infektion.

Tillsammans med ett ”Letter of Intent” har Vicore Pharma lämnat in de första regulatoriska dokumenten för en initial granskning i linje med den ”rullande” utvärdering som avtalats med MHRA. Den formella ansökan kommer att vara inlämnad när alla nödvändiga handlingar finns tillgängliga. MHRA’s beslut väntas då kort därefter.

C21, den första substansen i sin klass när det gäller lågmolekylära angiotensin II-receptor typ 2 (AT2R)-agonister, tillhör den skyddande delen i renin angiotensinsystemet (RAS), och är under utveckling för idiopatisk lungfibros (IPF) och undersöks också i systemisk skleros-patienter. Kombinationen av interna prekliniska fynd med C21 och det faktum att RAS spelar en nyckelroll i utvecklingen av COVID-19, pekar mot att C21 skulle kunna utgöra en behandling av sjukdomen. Därför har Vicore Pharma inlett en dialog med MHRA som inbjuder till initiativ för att studera möjliga nya behandlingar av COVID-19.

Det finns en god vetenskaplig grund för att studera C21 för behandling av COVID-19. Det har nyligen visats att CoV-2-viruset använder enzymet ACE2, en del av RAS, för att komma in och infektera lungceller. Detta avaktiverar ACE2-enzymet, vilket skapar en obalans i det lokala RAS, med akut lungskada som följd. Eftersom ACE2 genererar de naturliga liganderna för AT2R har Vicore Pharma gjort antagandet att C21 genom att agera direkt på AT2R skulle kunna undertrycka inflammatoriska mediatorer och därigenom förhindra virusets möjligheter att slå ut systemet.

"Att testa konceptet med en AT2R-agonist är innovativt och representerar en helt ny ansats för att behandla COVID-19" säger professor Joanna Porter, London University College, Chief Investigator för studien.

Den föreslagna studien kommer att vara randomiserad, dubbelblindad och placebokontrollerad med cirka 50 infekterade patienter med en måttligt allvarlig sjukdom som kräver syrgasbehandling, men inte respirator. Studien kommer att undersöka effektiviteten vid andningsingsinsufficiens mätt som kapaciteten att syresätta blodet.

"I denna kritiska tid är det viktigt att prova  alla möjligheter att bekämpa en av de värsta pandemierna i modern tid” säger Carl-Johan Dalsgaard, VD för Vicore Pharma,”och vi är glada att samarbeta med den kliniska kontraktsforskningsorganisationen Orphan Reach som har tagit sig an uppdraget med mycket kort varsel.”

MHRA är en förkortning för “The Medicines and Healthcare products Regulatory Agency”
 

Vicore kommer att hålla en webbsändning för att presentera studien och dess bakgrund idag kl. 14:00 (CET). Sändningen är tillgänglig via länken:

https://financialhearings.com/event/12848

Presentationen kommer att finnas tillgänglig innan webbsändningen på:

 https://vicorepharma.com/investerare/events-presentationer/   

 

För ytterligare information, vänligen kontakta:

Carl-Johan Dalsgaard, VD, tel: +46 70 975 98 63, carl-johan.dalsgaard@vicorepharma.com  

 

 Denna information är sådan information som Vicore Pharma Holding AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 31 mars 2020 kl. 08:00 CET.

 

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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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