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Hansa Medical’s clinical Phase I study with IdeS has been initiated

Regulatory information
Hansa Medical AB announces that the first healthy volunteer has been dosed with IdeS. The Phase I trial is performed in Sweden and involves 36 healthy volunteers. The study is double blind and randomised, whereby the volunteers will be administered intravenous single doses of either IdeS or placebo. Primary objectives are to study tolerability and safety of IdeS, as well as its effects and pharmacokinetics.

Hansa Medical is developing the biopharmaceutical candidate IdeS as a one-off treatment in conjunction with kidney transplantation. IdeS is an enzyme targeting and inactivating IgG antibodies. For the most part, IgG antibodies are a well functioning part of the human immune system. However, for 15 percent of patients awaiting kidney transplants, some of these antibodies constitute an immediate barrier for transplantation. Patients with high levels of antibodies targeting a potentially new organ are referred to as sensitized. Sensitized patients are normally put on hold for many years before reaching the top of the transplant waiting list. In many cases these patients never become eligible for a kidney transplant at all. The biopharmaceutical candidate IdeS has the potential to become the primary treatment method in facilitating transplantation for sensitized patients. The market potential is estimated to SEK 1 billion.

The objective is to finalize the Phase I study with healthy volunteers in 2013 and initiate a Phase II-study with sensitized transplantation patients in 2014. The patient group sensitized patients is a relatively small patient group but with a significant unmet medical need. The prospect for Hansa Medical to receive orphan drug designation for IdeS is estimated to be most favourable as soon as clinical data has been generated. The investment requirement for bringing the IdeS program to market approval is estimated to be significantly lower than for traditional drug development programs.