SEOUL, South Korea — ImmunAbs Inc., a clinical-stage biotech company focused on antibody therapeutics, has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of IM-101, its novel complement C5 inhibitor for the treatment of Myasthenia Gravis (MG).
The FDA’s Investigational New Drug (IND) approval allows ImmunAbs to move forward with a randomized, double-blind, placebo-controlled study enrolling up to 90 patients. The trial will assess the safety and efficacy of monthly IM-101 injections in reducing complement-mediated symptoms in MG patients.
“This IND approval is pivotal for us as it brings us one step closer to delivering a transformative therapy for patients with autoimmune disorders,” said Dr. Dongjo Kim, CEO of ImmunAbs. “We believe IM-101 has the potential to achieve deeper therapeutic responses and longer-lasting remissions, especially in patients who have not found success with existing treatments.”
Myasthenia Gravis is a rare autoimmune neuromuscular disorder that impairs voluntary muscle movement and can lead to severe complications. Current therapies targeting complement protein C5 have improved outcomes, but many patients still experience residual disease activity due to incomplete pathway inhibition.
ImmunAbs aims to address this gap by targeting both the classical and alternative complement pathways—believed to be critical in MG progression. By offering broader complement suppression, the company hopes IM-101 will provide more comprehensive disease control.
The upcoming Phase 2 trial represents a major step in advancing ImmunAbs’ pipeline and could pave the way for a new class of therapies in the treatment of autoimmune neuromuscular disorders.
