ImmunAbs Announces FDA Phase 2 IND Approval of IM-101, a Novel Complement C5 Inhibitor, for Treatment of Myasthenia Gravis

Business Wire

3 days ago

SEOUL, South Korea--(BUSINESS WIRE)--ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating the safety and efficacy of IM-101, a novel complement C5 inhibitor, for the treatment of Myasthenia Gravis.
The forthcoming multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to evaluate the effectiveness and safety of monthly IM-101 dosing in relieving complement-induced symptoms in MG.
'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, the CEO of ImmunAbs, 'we believe IM-101 has the potential to deliver deeper therapeutic responses and more durable remissions in patients who have failed to achieve sustained remission with current approved treatment.'
About Myasthenia Gravis
Myasthenia Gravis (MG) is a rare neurological disorder that severely impairs muscle movement and can lead to life-threatening complications. While existing C5 inhibitors have contributed to improved remission rates, many patients still experience residual disease activity due to incomplete complement inhibition. In addition to autoantibody-mediated activation of the classical complement pathway, MG pathogenesis is also significantly influenced by activation of the alternative pathway. ImmunAbs believes that comprehensive inhibition of both the classical and alternative pathways is essential for minimizing residual complement activity and enabling revolutionary treatments for MG.
About IM-101
IM-101 is a humanized monoclonal antibody targeting complement C5 with high affinity. In the recently concluded Phase 1 clinical trial, IM-101 demonstrated an excellent safety profile and was well tolerated at all tested doses, with no dose-limiting toxicity or severe adverse events observed. The clinical results showcasing IM-101's outstanding ability to reduce serum free C5 concentrations in healthy volunteers provide strong evidence of its superior efficacy in complement inhibition.
About ImmunAbs
ImmunAbs is a clinical-stage biotechnology company established in 2017. Committed to delivering transformative treatments globally, the company aims to develop novel antibody therapeutics, particularly concentrating its efforts on the lead program targeting severe autoimmune diseases. Supported by equity funding and national grants from KDDF, which covered development from non-clinical through Phase 1 clinical studies, ImmunAbs is now seeking global partnerships to accelerate the advancement of IM-101 towards market availability.