Vicore Pharma meddelar sista besöket av sista patienten i den mekanistiska fas II studien med C21 i systemisk skleros

2020-12-15

Göteborg, 15 december 2020 – Vicore Pharma Holding AB (publ), som utvecklar innovativa läkemedel mot allvarliga lungsjukdomar, meddelar idag att den sista patienten har genomfört sitt sista besök i den mekanistiska fas II-studien av Raynauds fenomen hos patienter med systemisk skleros.
  • Studien har avslutats med 12 genomförda patienter
  • Översiktliga resultat beräknas vara tillgängliga i februari 2021

“Efter att ha säkerställt att vi kan erhålla tillräcklig statistisk tillförlitlighet för att kunna bedöma om C21 har effekt så har vi beslutat att avsluta rekryteringen efter 12 genomförda patienter”, säger Carl-Johan Dalsgaard, VD för Vicore Pharma. ”Vi är mycket nöjda med att vi har lyckats slutföra patientrekryteringen i dessa svåra tider och vi ser fram emot att kunna presentera ”top line”-resultaten i februari 2021”.  

Studiedesign och syfte  
Studien är designed för att undersöka effekterna av en singeldos C21 på köldinducerad kärlsammandragning, så kallat Raynauds fenomen (RP), hos patienter med systemisk skleros (SSc).  Studien kan tydliggöra AT2 receptorns roll för att akut förbättra blodflödet i sjuka vävnader. Om resultaten är positiva ger det ytterligare stöd för att C21 positivt kan påverka de sjukliga lungkärlsförändringar som ofta ses hos patienter med SSc-relaterad lungfibros och idiopatisk lungfibros (IPF). Studien var planerad för att rekrytera upp till 16 patienter men på grund av utmaningarna orsakade av COVID-19 beslutades att avsluta studien med det minimalt nödvändiga antalet patienter.

Om  systemisk skleros (SSc)
SSc är en sjukdom med en tydlig koppling till angiotensin II och en uppreglering av angiotensin II typ 2-receptorn (som C21 verkar genom) som är känd för att mediera såväl anti-fibrotiska effekter som gynnsamma vaskulära förändringar i ett antal sjukdomsmodeller för lungfibros och pulmonell hypertension.

SSc är en allvarlig, sällsynt, kronisk, autoimmun sjukdom som påverkar både hud och inre organ som till exempel lunga och njure. Det finns inget botemedel och svåra fall behandlas med potenta immunmodulerande läkemedel eller benmärgstransplantation men med kvarstående utmaningar och stort medicinskt behov. Prevalensen uppskattas till 7-34 och 14–44 per 100 000 individer i Europa respektive Nordamerika. Den årliga incidensen uppskattas till 1–2 och 1–6 per 100 000 individer i Europa respektive Nordamerika. SSc är 3–4 gånger så vanligt hos kvinnor som hos män. Det uppskattas att 20 procent av patienterna med SSc har den svåra diffusa formen. Mellan 30 och 50 procent av patienterna lider därtill också av interstitiell lungsjukdom.

C21 (VP01 projektetet), första substansen i sin klass, AT2R agonist                          
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). Den är under utveckling för idiopatisk lungfibros (IPF) och har nyligen rapporterats ha gynnsamma effekter på COVID-19-patienter

För ytterligare information, vänligen kontakta:
Carl-Johan Dalsgaard, VD
T: 070 975 98 63
E: carl-johan.dalsgaard@vicorepharma.com  

Informationen lämnades för offentliggörande den 15 december  2020 kl. 08:00 CET.

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