Hansa Medical AB has announced completion of a Phase II study entitled “A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation” in which 10 sensitized kidney patients were given IdeS prior to transplantation.
The primary and secondary objectives were met with IdeS in the study.
Dr. Steven Glazer, Chief Medical Officer at Hansa Medical said: “We are encouraged by these results. These data further support our belief that our novel immunomodulatory enzyme holds significant therapeutic value for sensitized patients in need of lifesaving transplantation. We plan to move forward with continued recruitment of patients to our ongoing multi-center study with IdeS in highly sensitized kidney transplantation patients, allowing us to accumulate additional data and further evidence of the value of IdeS and our clinical program.”
In a separate press release also issued on Wednesday Hansa Medical has announced that it will not continue its clinical Phase II study with IdeS in acquired TTP. The decision follows Hansa Medical’s review of initial results from the study demonstrating a non-favourable risk benefit profile. This decision to discontinue the study has no impact on Hansa Medical’s ongoing studies with IdeS in renal transplantation
or planned studies in other autoimmune indications.
The company explained that the initial data from treatment of two patients with asymptomatic TTP clearly demonstrated that IdeS effectively cleaves IgG antibodies, including all pathogenic anti-ADAMTS13 autoantibodies. However, the efficient cleaving of the anti-ADAMTS13 autoantibodies did not result in a convincing positive effect on the activity of the ADAMTS13 enzyme in relation to the level of adverse events observed. Both patients treated in the study experienced symptoms including fever, rash and joint pain approximately one week after treatment, possibly
related to treatment with IdeS in asymptomatic TTP-patients. The symptoms were clinically manageable and unexpected based on observations from completed and ongoing studies.
Dr. Steven Glazer, Chief Medical Officer of Hansa Medical, commented: “Hansa Medical has a deep commitment to the development of
antibody-degrading and antibody-modulating enzymes for use in transplantation and autoimmune diseases. While we are disappointed that we were not able to demonstrate a convincing risk benefit profile in asymptomatic patients with acquired TTP, we are optimistic about the clinical development of IdeS in our lead programs, including transplant patients. These findings in asymptomatic TTP patients have no implications for ongoing studies with IdeS in transplantation or other planned studies in autoimmune indications. We are evaluating the
possibility to investigate the safety and efficacy of IdeS in symptomatic acute patients with TTP in a separate Phase II study in the future.”