Cantargia announced that the application for a phase I clinical trial with the IL1RAP-binding antibody CAN10 has been approved. The trial will investigate the safety of various single and multiple dose levels of CAN10 given intravenously to healthy volunteers or subcutaneously to psoriasis patients. Up to 80 subjects may be included in the trial, which is expected to start in September 2023.

Following the approval by both the regulatory authority as well as the ethics committee in Germany, the phase I trial will now be initiated. The CAN10 antibody strongly binds IL1RAP and simultaneously blocks the function of the signaling molecules IL-1, IL-33 and IL-36, which play key roles in several autoimmune and inflammatory diseases. Cantargia is initially focusing the development of CAN10 on systemic sclerosis and myocarditis, two diseases with a high medical need.

CAN10 has shown promising effects in several models of these diseases. The primary objective of this phase I trial is to investigate the safety and tolerability of CAN10 using a standard design involving single ascending doses (SAD), followed by evaluation of multiple ascending doses (MAD). Further objectives include pharmacokinetics and effects on various immunological or disease-related biomarkers.

Initially, single ascending doses will be given intravenously to healthy volunteers. A subsequent part of the trial is designed to generate an early proof-of-concept in up to 16 patients with mild to moderate psoriasis who will receive CAN10 subcutaneously at two dose levels. Indication of clinically relevant effects on biomarkers will also be evaluated throughout the study.

Treatment is expected to start in September2023.