ImmunAbs, a leading clinical-stage biotechnology company focused on developing novel antibody therapeutics, today announced the successful completion of the Phase 1 clinical trial for IM-101. IM-101 is a humanized monoclonal antibody targeting complement C5, which plays a pivotal role in complement activation. The complement system is widely acknowledged for its critical involvement in autoimmune diseases.

The randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety, tolerability, and preliminary efficacy of IM-101, a drug targeting the complement system, particularly complement C5. Healthy volunteers were enrolled to receive a single-ascending dose of IM-101 or placebo. Notably, IM-101 demonstrated good tolerability, with no severe adverse events or dose limiting toxicity (DLT) observed at any tested dosage. ImmunAbs is pleased to report that the trial has successfully met all predefined endpoints.

Dr. Dongjo Kim, the CEO of ImmunAbs, conveyed his excitement about the results, stating, "we are excited to share that the topline results are positive. In this trial, we assessed a critical biomarker for complement inhibition -- serum free C5 concentration -- confirming the efficacy of IM-101 in binding to C5 in humans. These outcomes lay a solid foundation for addressing the unmet medical needs of patients experiencing residual symptoms despite receiving the current standard of care. We eagerly await to see the therapeutic potential of IM-101 in the forthcoming Phase 2 study".