Idogen submits an application to the Swedish Medical Products Agency to initiate a clinical phase 1/2a study of the cell therapy treatment IDO 8
Idogen AB announces today that it has submitted a clinical trial application to the Swedish Medical Products Agency (MPA) to begin its clinical phase 1/2a study of the company's most advanced cell therapy treatment, IDO 8. IDO 8 aims to create tolerance to factor VIII, thereby enabling ongoing substitution treatment with coagulation factor VIII – a vital treatment in hemophilia (hemophilia A) against which many patients develop antibodies. The aim of the planned phase 1/2a study, which has been designed in close dialogue with the regulatory authorities in the Nordic countries, is to evaluate the safety of IDO 8 and to monitor patients for signals of a clinical treatment effect. The planned start date of the trial is dependent on the MPA review process, but it is anticipated the study, once approved, will be initiated in the second quarter of 2022.
Idogen's cell therapy is tailored for each individual patient in a GMP-certified laboratory at the company's manufacturing partner Radboud University Medical Center in the Netherlands. The therapy is based on the patient's own cells and is therefore expected to have a favorable safety profile and to create a long-term treatment effect. The company is now initially submitting the application to start the phase 1/2a study to the MPA.
“We are now taking a much-desired step towards the clinical development of IDO 8 for patients who are in need of a means of successfully continuing their treatment for hemophilia even in a situation where FVIII reactive antibodies have been developed. The application is a result of our solid preclinical research efforts and successful work in scaling up our manufacturing process from laboratory scale to industrial scale. We look forward to the continued interaction with the MPA and hope to soon be able to start the clinical phase 1/2a study in patients in Sweden," says Anders Karlsson, CEO of Idogen.
For further information, please contact:
Anders Karlsson, CEO, Idogen AB
Phone: +46 (0)70 918 00 10
Email: anders.karlsson@idogen.com
Certified Adviser:
Erik Penser Bank AB, Box 7405, 103 91 Stockholm
Phone: +46 (0)8-463 80 00
Email: certifiedadviser@penser.se
The information was submitted for publication through the above contact person on 17 December 2021 12:03 CET.
The English text is an unofficial translation of the original Swedish text. In case of any discrepancies between the Swedish text and the English translation, the Swedish text shall prevail.
Idogen (Nasdaq First Growth Market: IDOGEN) develops tolerogenic cell therapies to prevent the patient’s immune system from attacking biological agents, transplanted organs or the body's own cells or tissue. The company’s most advanced project, IDO 8, is designed to restore the efficacy of hemophilia drugs in patients who have developed neutralizing antibodies. The company’s second project, IDO T, is being developed to prevent kidney transplant rejection. In a third programme, IDO AID, Idogen is focused on the treatment of autoimmune diseases. The treatment for all indications is based on the patient's own cells and is expected to have a favorable safety profile and long-lasting effect. The potential for a short-term treatment intervention to yield a long-term effect is a major advantage in health economics for both patients and divisions providing care. More information about Idogen is available via https://www.idogen.com
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