A phase 3 trial of Immunovant’s FcRn inhibitor batoclimab has hit its primary endpoint. But, having made a second-generation molecule its lead candidate last year, the biotech isn’t currently planning to file for batoclimab approval in myasthenia gravis or chronic inflammatory demyelinating polyneuropathy (CIDP).
Immunovant switched its focus from batoclimab to IMVT-1402, another FcRn inhibitor, last year. Talking at the J.P. Morgan Healthcare Conference in January, CEO Pete Salzmann, M.D., said Immunovant’s “base case” was that it would opt against commercializing batoclimab. Neither the phase 3 myasthenia gravis data nor phase 2b data in CIDP have persuaded the biotech to veer away from this strategy.
The myasthenia gravis trial linked low and high doses of batoclimab to 4.7- and 5.6-point improvements, respectively, on the MG-ADL symptom and activity scale. Scores improved by 3.6 points in the placebo cohort. The gap between the treatment and control groups caused the trial to hit its primary endpoint.
Efficacy correlated to IgG reduction, with Immunovant seeing declines of 64% and 74%, respectively, on the low and high doses. The biotech compared the results to data on argenx’s Vyvgart and Johnson & Johnson’s nipocalimab. Immunovant’s rivals linked their FcRn inhibitors to similar levels of IgG reductions and MG-ADL improvements as the low dose of batoclimab.
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Despite claiming the high dose “breaks the therapeutic ceiling,” Immunovant isn’t planning to bring the drug candidate to market in myasthenia gravis. The decision reflects evidence batoclimab lowers albumin and, in doing so, affects cholesterol. Believing it has mitigated that problem with IMVT-1402, the biotech presented the batoclimab data as evidence that its next-generation candidate will beat the competition.
“What we're clearly gonna be able to do better, based on this dataset, is get deeper faster and hold those responses for longer,” Matt Gline, CEO of majority Immunovant shareholder Roivant, said on a call with investors to discuss the data. “That's the impact of the deeper IgG suppression that we deliver.”
Switching to IMVT-1402 extends the head starts Immunovant has already ceded to its rivals. Argenx won FDA approval for Vyvgart in 2021 and launched a subcutaneous version in 2023. Immunovant is yet to start a phase 3 trial of IMVT-1402 in myasthenia gravis.
The biotech confirmed IMVT-1402 is its lead candidate in CIDP after getting a look at phase 2b data on batoclimab in the indication. Immunovant linked the molecule to improvements on multiple CIDP scales, with 84% of people who had at least a 70% drop in IgG meeting its response criteria. But, like in myasthenia gravis, the biotech has decided to take IMVT-1402 forward in the indication.
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Investors reacted negatively to the news, sending Immunovant’s stock down 10% to below $17 before the market opened.
However, some analysts were more upbeat. Asking a question on Immunovant’s call, Piper Sandler’s Yasmeen Rahimi, Ph.D., said: “The most important thing that you proved, and that's incredible, is the debate on whether deeper matters. I think this data today, this morning, really put that to rest.”