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Dive Brief:
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Immunovant gave investors a mixed set of news Wednesday, touting late-stage results for an experimental autoimmune disease drug while saying the company doesn’t currently plan to seek regulatory approval.
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According to Immunovant, the medicine, batoclimab, succeeded in a Phase 3 study of patients with myasthenia gravis and the first part of a Phase 2b trial focused on an immune condition that damages nerves. But the company is prioritizing a follow-on drug called IMVT-1402 and doesn’t plan to submit batoclimab for approval for those indications at this time.
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Instead of using the latest clinical trials to get batoclimab to market, Immunovant plans on “leveraging data and learnings from the batoclimab studies to inform and accelerate its programs with IMVT-1402.” Still, the company said no final decisions will be made until ongoing Phase 3 studies of batoclimab in thyroid eye disease are available.
Dive Insight:
Immunovant believes IMVT-1402 has “best-in-class” potential and wants to maximize that drug, even if it’s behind batoclimab in development. The company already told investors it was making IMVT-1402 the priority in May 2024, when it pushed back timelines for those mid- to late-stage trials, wagering the knowledge available from a longer period of research would bolster IMVT-1402.
Batoclimab and IMVT-1402 are FcRn inhibitors, which work by preventing the body from recycling immunoglobulin, or IgG, back into the blood. Both Argenx and UCB already sell medicines in the class, and Johnson & Johnson is developing another one.
In a presentation for investors on Wednesday, Immunovant said batoclimab has shown better results than other medicines in its class, based on comparisons of individual clinical trials. Yet such comparisons can be misleading due to differences in patient population and the duration of study.
Thomas Smith, an analyst at Leerink Partners, wrote in a note to clients that such differences made Immunovant’s data more difficult to compare versus other drugs. “However, we believe the totality of these data are largely supportive of the value proposition” for IMVT-1402, Smith wrote.
IMVT-1402 could improve on batoclimab’s data by offering better tolerability for patients along with deep and durable responses, the company said.
IMVT-1402 would be the only drug in its class positioned to launch in an autoinjector, according to Immunovant. That may allow patients to self-administer the drug at home, per the company’s website. Competing drugs such as Vyvgart require injections at doctors’ offices.