Idogen adds Norway for its clinical phase 1/2a study and submits an application for approval for its cell therapy treatment IDO 8 to the Norwegian Medicines Agency NoMA

Idogen AB announces today 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.

 

The company has previously, on 17 December 2021, submitted an application to the Medical Products Agency in Sweden to start its phase 1/2a study and now Norway is also being added as a country to participate in the study.

 

“We are very pleased that the positive discussions we have had with clinical experts in Norway have now resulted in the intention to participate in our first clinical study with IDO 8. This is another important and long-awaited step to enable effective treatment of patients with severe hemophilia A and who have developed neutralizing antibodies to their vital treatment”, says Anders Karlsson, CEO of Idogen.

 

 

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 11 January 2022 at 12:00 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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Quotes

We are very pleased that the positive discussions we have had with clinical experts in Norway have now resulted in the intention to participate in our first clinical study with IDO 8. This is another important and long-awaited step to enable effective treatment of patients with severe hemophilia A and who have developed neutralizing antibodies to their vital treatment
Anders Karlsson, CEO of Idogen.