Positivt FDA-besked för Guard Therapeutics njurbehandling

Svenska biotech-bolaget Guard Therapeutics har fått sin IND-ansökan (Investigational New Drug) godkänd av FDA och kan nu bredda sina kliniska studier till att omfatta även sjukhus i USA.

By Anders Göransson

October 10, 2022 10:25 AM

Läkemedelskandidaten RMC-035 utvecklas som en intravenös korttidsbehandling mot akuta njurskador. För närvarande pågår en fas II-studie, som väntas omfatta cirka 270 patienter, för att utvärdera och dokumentera behandlingens njurskyddande effekt hos patienter som genomgår öppen hjärtkirurgi. Samtidigt genomförs en mindre fas Ib-studie i patienter som genomgår njurtransplantation.

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