Immunovant to Launch US Phase 3 Trial for Batoclimab in MG
The announcement came after the company reached an agreement with the division of neurology within the U.S. Food and Drug Administration (FDA) regarding the trial — designed to evaluate alternate dosing regimens for both disease maintenance and flare-ups.
“We believe we have a differentiating approach to studying batoclimab in myasthenia gravis,” Bill Macias, MD, Immunovant’s chief medical officer, said in a press release.
Batoclimab, also known as IMVT-1401, works by blocking the FcRn protein receptor, which plays a key role in preventing antibodies called immunoglobulin G (IgG) from being degraded.
In MG, self-reactive IgG antibodies mistakenly attack the neuromuscular junction, the place where nerve endings connect with the muscle cells they control. As a result, muscles cannot contract properly and become progressively weaker.
By blocking FcRn, disease-causing IgGs are more readily degraded, which reduces their numbers — potentially easing MG flare-ups.
Eligible participants must be positive for IgG antibodies that specifically target the acetylcholine receptor within the neuromuscular junction.
The Phase 3 study will begin with a 12-week induction period, in which Immunovant plans to administer batoclimab at doses of 340 and 680 milligrams or a placebo weekly by subcutaneous (under-the-skin) injections.
The primary efficacy outcome will be assessed by the MG Activities of Daily Living (MG-ADL) scale, a validated patient-reported measure of MG severity.
The company will also explore alternative dosing regimens in additional study periods, including lower dosing for disease maintenance and higher rescue doses to treat MG flare-ups.
“Specifically, by applying an induction and maintenance paradigm, we aspire to develop the first anti-FcRn with flexible dosing,” Macias added. “This approach has the potential to maximize the benefits of batoclimab’s unique product attributes.”
According to Immunovant, the trial is on track to begin in the first half of this year, with data expected in 2024. The safety and monitoring protocols are expected to follow FDA guidelines, similar to those used in other clinical programs.
“Based on our market research, we believe that people living with myasthenia gravis desire to achieve significant clinical improvement and want to maintain this improvement without experiencing disease flares,” Pete Salzmann, MD, CEO at Immunovant, said.
“Our Phase 3 trial was designed around these insights and is intended to take advantage of batoclimab’s broad therapeutic window and a simple subcutaneous delivery device to provide a patient-friendly dosing experience,” Salzmann added.
This Phase 3 study was supported by data from a previous Phase 2 trial (NCT04346888) including 30 adults with moderate to severe gMG living in China. It demonstrated batoclimab was able to lower the levels of disease-causing IgGs and ease MG symptoms.
The therapy was generally safe and well tolerated, with mostly mild adverse events (side effects) and no serious adverse events or treatment-related discontinuations reported.