Immunovant Refocuses on Different FcRn Inhibitor, Eases Pressure on Vyvgart

Immunovant, a subsidiary of Roivant Sciences, announced a strategic shift on Wednesday, moving its focus from batoclimab, a treatment for myasthenia gravis, to IMVT-1402, another drug targeting autoimmune disorders. This change comes after positive data on IMVT-1402 from Roivant’s 2022 Investor Day. The company plans to prioritize IMVT-1402 in treating Graves’ disease and other autoimmune conditions, initiating four to five key studies in endocrinology, neurology, and other fields by the end of the fiscal year on March 31, 2025. Additionally, they aim to undertake 10 studies for IMVT-1402 by March 31, 2026.

While Immunovant will release topline results for batoclimab in myasthenia gravis (MG) within this fiscal year, they will also make a final decision on the drug’s future. Despite this shift, MG remains a significant target for IMVT-1402, with plans to commence a specific program for this chronic autoimmune disorder.

CEO Pete Salzmann stated that IMVT-1402 presents a unique opportunity within its class, combining potentially best-in-class features unseen in other FcRn inhibitors. He emphasized that due to the substantial progress and broad potential of IMVT-1402 across several indications, the company has decided to make it their lead asset.

Investment analysts from William Blair noted that this shift allows argenx’s Vyvgart, approved by the FDA for MG in 2021, to maintain a competitive edge. They acknowledged the reasoning behind Immunovant’s move, especially considering the challenges associated with batoclimab, such as LDL lowering, a liability not observed with IMVT-1402. Nevertheless, they pointed out that this decision delays Immunovant’s commercialization efforts, giving argenx a more substantial lead in the MG market.

The challenges of clinical trial design in autoimmune populations were highlighted by the analysts, illustrating the complexity beyond merely developing an effective IgG-lowering agent.

Immunovant's ambitions extend beyond MG. The company is contemplating transitioning the study of batoclimab for chronic inflammatory demyelinating polyneuropathy (CIDP) to a registrational program with IMVT-1402. Moreover, they plan to announce results from the batoclimab study in Graves’ disease and provide an overview of IMVT-1402’s progress in treating this autoimmune disorder by fall of this year.

In December 2023, Immunovant revealed results from a Phase II trial of batoclimab in treating Graves’ disease. The results were promising, with the drug exceeding a 50% response rate significantly.

This strategic pivot from batoclimab to IMVT-1402 marks a significant development in Immunovant’s approach to addressing autoimmune disorders, potentially influencing the competitive landscape and future treatment modalities.

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