ImmunAbs Inc., a clinical-stage biotechnology company, has received U.S. Food and Drug Administration clearance for its Investigational New Drug (IND) application to advance IM-101, a novel complement C5 inhibitor, into Phase 2 clinical trials for Myasthenia Gravis treatment. The Seoul-based company announced the regulatory milestone on June 2, 2025, marking a significant step forward in addressing unmet medical needs for patients with this rare neurological disorder.
Phase 2 Trial Design and Objectives
The upcoming 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 Myasthenia Gravis. The trial design reflects standard regulatory requirements for demonstrating therapeutic efficacy while maintaining rigorous safety monitoring protocols.
"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 deliver deeper therapeutic responses and more durable remissions in patients who have failed to achieve sustained remission with current approved treatment."
Addressing Limitations of Current Therapies
Myasthenia Gravis 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. The pathogenesis of MG involves both autoantibody-mediated activation of the classical complement pathway and significant influence from alternative pathway activation.
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. This dual-pathway approach represents a potential advancement over current therapeutic options that may not fully address all complement-mediated disease mechanisms.
IM-101 Clinical Profile and Mechanism
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 showcased IM-101's outstanding ability to reduce serum free C5 concentrations in healthy volunteers, providing strong evidence of its superior efficacy in complement inhibition.
The drug's mechanism of action focuses on comprehensive complement system inhibition, potentially addressing the incomplete therapeutic responses seen with current treatments. This approach may offer patients who have not achieved sustained remission with existing therapies a new treatment option with enhanced efficacy potential.
Company Background and Development Strategy
ImmunAbs is a clinical-stage biotechnology company established in 2017, committed to delivering transformative treatments globally through novel antibody therapeutics development. The company particularly concentrates its efforts on lead programs targeting severe autoimmune diseases, with IM-101 representing its flagship therapeutic candidate.
The company's development program has been 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, indicating the company's strategic focus on expanding its therapeutic reach and development capabilities.
