Idogen receives approval from the Swedish Medical Products Agency for its clinical phase 1/2a study
Idogen AB (publ) has received the Swedish Medical Products Agency's approval for its clinical phase 1/2a study for IDO 8, a completely new type of cell therapy for patients with severe hemophilia A who have developed antibodies to their vital treatment with coagulation factor VIII. The company is expected to be able to begin patient recruitment during the second quarter of 2022 after the Medical Products Agency's formal approval of the study's Swedish clinic.
Idogen develops tolerogenic cell therapies where the goal is to prevent an unwanted activation of the immune system. For patients with hemophilia A, standard treatment consists of coagulation factor VIII, but one third of patients develop neutralizing antibodies to the treatment and render it inactive. To prevent the body's immune system from attacking such biological drugs, Idogen has developed a patient-specific cell therapy with the intention of creating tolerance for the patient's treatment with factor VIII concentrate. The goal is that the patient can thus continue with his vital treatment.
The clinical phase 1/2a study with Idogen's tolerogenic cell therapy IDO 8 will be conducted at several European trial centers. To date, the company has submitted applications for approval of its clinical trial for implementation in Sweden and Norway. The study is a dose escalation study where three different doses will primarily be evaluated with regard to safety, but also provide the opportunity to follow signals on preliminary effect parameters. The study will include nine patients and is expected to continue during 2022–2023. Evaluation of the study's primary and secondary endpoints will be done 26 weeks after the patient has received his treatment with IDO 8 and in addition, a first long-term follow-up will be done after 52 weeks.
“The approval is another important milestone and a long-awaited step in the development journey for our cell therapy IDO 8 with the ultimate goal of helping patients with hemophilia to a better life. After a successful effort to move our manufacturing process from laboratory scale to industrial scale, we now look forward to starting the clinical phase 1/2a study with IDO 8 ", says Idogen's CEO Anders Karlsson.
The clinical study has been designed in close dialogue with leading specialists in coagulation disorders and regulatory authorities in the Nordic region with the aim of evaluating the safety of IDO 8 and following signals of treatment effect in patients.
For further information, please contact:
Anders Karlsson, CEO, Idogen AB
Phone: +46 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 agency of the contact persons set out above, on 21 March 2022 at 08.14 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