Idogen AB announced that in addition to its Swedish application, it has also sub-mitted an application to the Norwegian Medicines Agency, NoMA, to be able to begin its clinical phase 1/2a study of the company's most advanced cell therapy treatment IDO 8 in Norway. IDO 8 aims to create tolerance for factor VIII and thus enable ongoing substitu-tion treatment with coagulation factor VIII - a life-saving drug treatment for hemophilia A against which many patients develop antibodies. The aim of the planned phase 1/2a study, which was designed in close dialogue with clinical experts and regulatory authorities in the Nordic region, is to evaluate the safety of IDO 8 and follow signals of treatment effect in patients.

Given that the application is approved by NoMA without adjustments, the study is planned to start during the second quarter of 2022. Idogen's cell therapy is tailored for each individual patient in a GMP-certified facility at the company's manufacturing partner Radboud University Medical Center (RUMC) in the Netherlands. The therapy is based on the patient's own cells and is expected to have a favorable safety profile and the opportunity to create a long-term treatment effect.