First product – antibodies in hemophilia A
Idogens first product is intended to treat patients with severe hemophilia A affected by neutralising antibodies against its vital coagulation factor VIII-treatment. These patients have no effect of coagulation factor VIII and has a high mortality and significant unmet medical needs. Idogen has selected haemophilia A as the first indication because the medical need in these patients is high and the disease has a well-defined antigen, which means that there are good opportunities to develop a successful treatment for this population. The project is in preclinical phase and is expected to enter clinical phase I/II for the first test in humans in 2018. The segment of hemophiliacs who Idogen plan to treat can, at 50% penetration of the market, represent a market of over 1 billion annually. In January 2017, Idogen was granted an orphan drug designation for the treatment in Europe, which has a number of advantages such as less extensive clinical trials, support from authorities and market exclusivity ten years after approval.
Second therapeutic area – kidney transplantation
Idogen’s second therapy area will be a tolerogenic vaccine to prevent transplant rejection, primarily kidney transplantation. Kidney transplantation is the most common type of organ transplant and globally, almost 80,000 kidney transplants are carried out each year, of which about 20,000 takes place in Europe. The largest and most serious complication is if the recipient’s immune system attacks, destroys and rejects the donated organ. To prevent this, the transplanted patients, with few exceptions, are given life-long treatment with a combination of drugs that inhibit the immune system. Although the proportion of patients that are able to keep a functioning transplanted kidney in the first year has increased over the last decades, there has been no improvement in the long-term graft survival. The immunosuppressive treatment also poses a risk of serious infections and cancer. Transplantation is thus a therapeutic area with a large unmet medical need. Idogen’s tolerogenic vaccine can provide the opportunity to improve graft survival and reduce the need for immunosuppressive drugs. The development work is being conducted with the intention of initiating a Phase I/IIa study within kidney transplantation in 2019.