Biotechnology company ImmunAbs has announced the successful completion of a Phase I clinical trial for IM-101, a humanised monoclonal antibody targeting complement C5.

The complement system is widely acknowledged for its critical involvement in autoimmune diseases.

The randomised, double-blind, placebo-controlled trial was conducted to evaluate the safety, tolerability, and preliminary efficacy of IM-101.

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. The trial successfully met all predefined endpoints.

Dr Dongjo Kim, CEO of ImmunAbs, said: “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 II study.”

ImmunAbs is actively pursuing additional investment and collaboration with the healthcare community to advance IM-101 towards market release.

Diana Spencer, Senior Digital Content Editor, DDW