- Fördelarna med samarbetet är många. Främst minskar Karo bios egen investering i eprotiromes fas III-program i och med att Alkem genomför en fas III-studie. Samarbetet bidrar till att bredda indikationsområdet för eprotirome genom att studierna i Indien genomförs på patienter som representerar en större patientpopulation, säger Karo bios vd Fredrik Lindgren.
Karo bio har jagat både partner och finansiering för en fas III-studie med blodfettssänkaren sedan fas II-studien blev klar för två och ett halvt år sedan. Hård konkurrens och strikta myndighetsregler har gjort att kolesterolsänkaren hamnat i motvind.
Under hösten 2010 tänkte Karo bio ett varv till och designade om studien för att testa preparatet för en nischindikation i Europa. Den nya indikationen kräver en mindre patientgrupp och företaget väljer nu att fokusera på en biomarkör, i detta fall LDL-kolesterol, vilket är ytterligare ett knep för att effektivisera studien. Nischen som Karo Bio riktar in sig på är patienter med sjukdomen heterozygot familjär hyperkolesterolemi, HeFH. Fas III-programmet för eprotirome har beräknats kosta 400 miljoner totalt. Genom samarbetet med Alkem räknar Karo bio med att spara 100 miljoner kronor.
Eprotirome är ett sköldkörtelhormon och förhoppningen är att det ska kunna användas av personer som behöver sänka sin halt av kolesterol i blodet. Enligt fas II-studier sänker substansen kolesterolnivån i blodet både då det ges som monoterapi och då det kombineras med standardbehandling för högt kolesterolvärde.










































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