Top-line findings in Phase 3 batoclimab trial likely by late March
Study looking at changes in MG-ADL scores with antibody therapy
Top-line results from a Phase 3 clinical trial of batoclimab in people with generalized myasthenia gravis (gMG) are expected by the end of March, Roivant, which is developing the antibody therapy through its subsidiary Immunovant, reported.
The company said that trial findings will inform further decisions regarding next steps for batoclimab, as well as next steps in the development of Immunovant’s lead therapeutic candidate for the disease, IMVT-1402.
“We … look forward to announcing multiple significant study outcomes this year including for batoclimab in MG,” Matt Gline, CEO of Roivant, said in a company press release.
Batoclimab findings may influence test of another antibody therapy, IMVT-1402
MG is caused by self-reactive antibodies that disrupt nerve-muscle communication. Both batoclimab and IMVT-1402 are designed to block the neonatal Fc receptor (FcRn), a protein that normally helps to stabilize antibodies circulating in the bloodstream. By blocking this protein, both therapies aim to accelerate the rate at which antibodies are broken down, thereby reducing the levels of MG-driving antibodies. The approved MG treatments Vyvgart (efgartigimod) and Rystiggo (rozanolixizumab) also work by targeting FcRn.
Although batoclimab and IMVT-1402 are designed to work in basically the same way, data from earlier studies suggest that batoclimab might cause cholesterol levels to rise as an unintended side effect. IMVT-1402 is designed to avoid this unwanted effect. A study in healthy volunteers indicated that it could effectively reduce antibody levels with minimal impact on cholesterol. As such, Immunovant has previously stated its plans to prioritize the development of IMVT-1402.
Both batoclimab and IMVT-1402 are designed to be administered by an under-the-skin injection.
The Phase 3 Flex trial (NCT05403541) is assessing batoclimab’s safety and efficacy in approximately 240 adults with gMG. In the trial’s first part, patients were randomly assigned to weekly injections of batoclimab, at one of two doses, or a placebo for 12 weeks, or about three months.
The study’s main goal is to evaluate the effect of treatment on the scores of the MG Activities of Daily Living (MG-ADL), a standardized measure of MG severity and its impact on day-to-day life. Specifically, the study is looking at the difference in MG-ADL scores after 12 weeks among people positive for antibodies targeting the acetylcholine receptor (AChR), the most common type of MG-causing antibody.
Patients given batoclimab in the trial’s first part are re-randomized in its second part to either continue receiving batoclimab or switch to a placebo.
Those who show a response to batoclimab in either of these two parts may enter a third, long-term extension phase. Participants who complete the study’s third portion then are eligible to participate in an optional long-term extension phase.
The Flex trial is designed to be pivotal, meaning that positive results could potentially support applications seeking batoclimab’s approval. Once batoclimab study findings are announced, Immunovant is planning to start a clinical trial program to test IMVT-1402 in MG.
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