Idogen has signed a strategic collaboration agreement with two contract research organizations, Danish Klifo and Finnish 4Pharma, which will together with Idogen run the clinical phase 1/2a study with IDO 8.
IDO 8 is a new cell therapy for patients with severe hemophilia who have developed antibodies to their treatment with coagulation factor VIII. The collaboration agreement applies to all testing centers in Europe where the study will be conducted.
“Last week, we received approval from the Medical Products Agency to start the IDO 8 study in Sweden, and with these collaboration agreements in place, we will soon be able to start patient recruitment. We look forward to welcoming the first patient into the study at the same time as we work in parallel to sign agreements with more trial centers in Europe,” says Idogen’s CEO Anders Karlsson.
The clinical phase 1/2a
During the second quarter of 2022, a clinical phase 1/2a study will begin with IDO 8 where the goal is to evaluate safety and follow signals of treatment effect in patients.
The clinical phase 1/2a study will be carried out at several European trial centers and in addition to Sweden, the company has so far submitted an application to be able to recruit patients in also in Norway. Klifo has been contracted for the overall responsibility for operationally conducting the clinical study, while 4Pharma’s role is focused on the design of systems for the collection and processing of biometric study data.
The study will include nine patients and is expected to continue during 2022–2023. An initial follow-up will be done 26 weeks after treatment and a long-term follow-up will be done 52 weeks after completed treatment.
Photo of Anders Karlsson: Idogen