Immunovant to launch phase 3 study of batoclimab for myasthenia gravis

Clinical-stage biopharmaceutical company Immunovant Inc. announced it has reached agreement with the FDA to initiate a phase 3 study of batoclimab in patients with myasthenia gravis in the first half of the year.

In an induction period, Immunovant intends to examine batoclimab study doses of 680 mg and 340 mg delivered weekly via subcutaneous injection. The company said in a press release that it will base the primary efficacy analysis on the Myasthenia Gravis-Activities of Daily Living profile assessed in participants who are positive for acetylcholine receptor antibodies, with this phase of the study occurring via 12 weeks of blinded, placebo-controlled therapy. Subsequent study periods will examine further treatment with alternative dosing regimens, including potential lower maintenance and higher rescue doses.

“We believe we have a differentiating approach to studying batoclimab in myasthenia gravis,” Bill Macias, MD, Immunovant chief medical officer, said in the release. “Specifically, by applying an induction and maintenance paradigm, we aspire to develop the first anti-FcRn with flexible dosing. This approach has the potential to maximize the benefits of batoclimab’s unique product attributes.”