Approval Granted to Resume FDA Clinical Trials for Myasthenia Gravis
Aiming to Start Phase 3 Clinical Trials in Japan in the Second Half of the Year
[Asia Economy Reporter Lee Gwan-joo] HanAll Biopharma's U.S. partner Immunovant announced on the 30th that it has initiated a Phase 3 clinical trial for HL161 (active ingredient batoclimab, Immunovant code name IMVT-1401), a subcutaneous autoimmune therapeutic agent under development for myasthenia gravis.
Immunovant voluntarily paused the HL161 clinical trial last year after observing an increase in LDL cholesterol in some patients during the Phase 2b trial for thyroid eye disease. Prioritizing patient safety, the company halted the trial temporarily. After expert consultation and cause analysis, the clinical monitoring program was revised, and additional discussions with the U.S. Food and Drug Administration (FDA) led to final approval to resume the trial. This is expected to accelerate the global clinical development.
The clinical trial conducted by Immunovant targets patients with myasthenia gravis and will last a total of 24 weeks (12 weeks induction phase, 12 weeks maintenance phase). During the induction phase, patients are divided into three groups receiving weekly doses of batoclimab 680 mg, 340 mg, or placebo for 12 weeks to induce rapid symptom improvement. In the maintenance phase, a low dose of 340 mg is administered either once weekly or once every two weeks for 12 weeks to assess the durability of the treatment effect. The primary endpoint is the improvement in symptoms as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale.
Immunovant designed the trial based on the insight that patients prefer to maintain an improved state rather than only administering treatment during symptom exacerbations such as shocks. Therefore, the trial starts with a high dose to quickly improve the condition, followed by a switch to a low dose for continuous management. Meanwhile, HanAll Biopharma aims to initiate a Phase 3 clinical trial for myasthenia gravis in Japan in the second half of this year.
Seungwon Jung, CEO of HanAll Biopharma, stated, “Drug development is a long journey that requires patience and prioritizes patient safety. Entering Phase 3 for HL161 is a success story overcoming the challenges encountered along this journey and reaffirms HanAll’s drug development capabilities. We will continue to develop HL161 for various autoimmune diseases and strive to improve the quality of life for myasthenia gravis patients worldwide.”
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