SEOUL -- ImmunAbs Inc., a clinical-stage biotech specializing in developing antibody therapeutics, 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.”
