IDO 8 – treatment of antibodies against factor VIII in Haemophilia A
IDO 8 is Idogen’s most advanced project, aimed at developing a tolerogenic cell therapy for patients with severe haemophilia A who have developed inhibitory antibodies against their standard treatment. Idogen´s treatment has the potential to restore the original efficacy of factor VIII treatment. The company has chosen haemophilia A as its first indication due to the major unmet medical need of these patients and because the disease has a well-defined antigen, presenting an opportunity to develop an effective treatment for this patient group. Haemophilia A is a rare disease and Idogen has been granted Orphan Drug Designation in Europe for the treatment – a key value-adding step for the company since orphan drug designation provides several advantages, such as less extensive requirements for clinical trials, scientific guidance from the regulator during development and ten-year market exclusivity after launch.
The company expects the first clinical trial to commence at the end of 2018 and has had constructive scientific discussions with the Swedish Medical Products Agency (MPA) regarding the design of the study.
IDO T- prevention of organ rejection in kidney transplantation
The same method that is currently under development for the treatment of haemophilia A can also be used for other indications with only minor adjustments of the production process. The company has therefore made a strategic decision to commence parallel development of a product candidate for kidney transplantation, IDO T. The basic principle is to “teach” the patient’s immune system to recognise and accept the transplanted organ rather than attack it. This could eventually reduce the need for current methods of often lifelong treatment with drugs that inhibit immune system functionality. There is a major unmet need for long-acting, cost-effective and safe treatment to avoid the risk of transplant rejection.
Preclinical development for IDO T is ongoing with the aim of commencing a Phase I/IIa clinical trial in 2019.