Phase 3 IMVT-1402 trial advancing in plans, with March as goal
Flex trial of batoclimab for gMG underway, with findings also due in March
By March, Immunovant plans to initiate four or five pivotal clinical trials of its lead therapeutic candidate IMVT-1402 across a range of autoimmune conditions, including myasthenia gravis (MG).
Pivotal, or registrational, trials are large-scale studies whose data could support regulatory applications seeking a therapy’s approval. Immunovant announced that it is in the process of submitting requests to U.S. regulators for clearance of these clinical studies, which it expects by year’s end.
Meanwhile, enrollment is complete in the pivotal Phase 3 Flex Study (NCT05403541) testing the investigational therapy batoclimab in people with generalized MG (gMG), Immunovant also stated in a company press release.
IMVT-1402, like batoclimab, works to clear blood of disease-causing antibodies
Both IMVT-1402 and batoclimab belong to a class of therapies called FcRn blockers. Immunovant indicated this year that it plans to prioritize IMVT-1402 over batoclimab for development, with the expectation that IMVT-1402 has a better overall therapeutic profile. A final decision will await Flex trial results, also due in March.
“We are encouraged by the progress we made this quarter on the execution of our plans for both batoclimab and IMVT-1402,” said Pete Salzmann, MD, the company’s CEO of Immunovant. “This is very exciting given the uniquely positive features of both the anti-FcRn class and the uniquely positive potential benefits of IMVT-1402.”
FcRn blockers, which include the approved MG therapies Vyvgart and Rystiggo, are designed to inhibit the interaction between a class of antibodies called immunoglobulin G (IgG) and the neonatal Fc receptor (FcRn). That receptor helps to prevent IgGs circulating in the bloodstream from being broken down.
The self-reactive antibodies that cause MG and many other autoimmune conditions belong to the IgG class. By blocking FcRn, these medications intend to accelerate the rate at which disease-causing antibodies are eliminated from the bloodstream, easing disease severity. Both batoclimab and IMVT-1402 are given via under-the-skin, or subcutaneous, injections.
IMVT-1402 thought to have a better overall profile than batoclimab as a therapy
In Phase 2 and Phase 3 clinical trials, batoclimab has been found to lower IgG levels and ease disease severity in adults with gMG. But an observed side effect of batoclimab in these studies was a reduction in a protein called albumin, whose lower levels cause blood cholesterol levels to rise.
IMVT-1402, a fully human antibody, is designed to bind to FcRn in a somewhat different way, leading to the same therapeutic benefits while avoiding this side effect. IMVT-1402 was reported to substantially lower IgG levels with minimal impact on albumin or cholesterol in Phase 1 testing in healthy adults.
The investigational therapy has not yet been tested in any specific disease. By 2026, Immunovant anticipates initiating clinical trials of IMVT-1402 in 10 indications, a mix of registrational and proof-of-concept studies.
Meanwhile, the global FLEX trial continues to compare the safety and efficacy of batoclimab to a placebo in about 240 adults with gMG. Its main goal is to evaluate the treatment’s effects on disease severity.
While Immunovant reports that trial findings will inform what happens next with batoclimab, it has not indicated whether the therapy’s development might be stopped.
Of note, Immunovant is developing batoclimab in the U.S. and Canada, so its decisions relating to the therapy would be limited to North America. Initially developed by HanAll BioPharma, batoclimab is being developed in China by Harbour BioMed, which recently submitted a regulatory application seeking its approval to treat gMG patients in that country.
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