Immunovant has announced that it has discontinued development of its first-generation FcRn inhibitor, batoclimab, roughly a month after the therapy failed in two phase 3 trials for thyroid eye disease (TED).
The company had initially announced plans in 2022 to evaluate batoclimab in two late-stage studies involving patients with TED. However, in early April, parent company Roivant Sciences revealed that both studies failed to meet their primary objective of achieving at least a 2 mm reduction in proptosis, or eye bulging.
TED is an autoimmune disease driven by immunoglobulin G (IgG). Last month, Roivant indicated that the greater reductions in proptosis observed during the higher-dose phase of treatment, compared with the lower-dose period, suggested that more intensive suppression of IgG may provide stronger therapeutic benefits.
At the time, the company stopped short of fully abandoning batoclimab, explaining in an April statement that it planned to reassess the therapy’s future alongside its South Korea–based partner HanAll Biopharma and would share further updates later.
However, in its first-quarter earnings report released this morning, Immunovant confirmed that development of batoclimab has officially ended. The biotech also disclosed that terminating the program resulted in $39 million in contractual costs, contributing to an increase in research and development expenses to over $456 million for the fiscal year ending March 31, compared with just under $361 million the previous year.
Even so, Immunovant suggested the program was not entirely without value. The company explained that insights gained from batoclimab, including clinical findings, operational experience from trials and collaborations with investigators, could help guide the advancement of its second-generation FcRn inhibitor, IMVT-1402.
Topline findings from a proof-of-concept study of IMVT-1402 in cutaneous lupus erythematosus are anticipated in the second half of this year. Meanwhile, results from a phase 2b trial in Graves’ disease are expected next year, and a study in treatment-resistant rheumatoid arthritis remains underway.
The company also shared preliminary findings from the rheumatoid arthritis trial, reporting that over 72% of the 170 heavily pretreated participants experienced at least a 20% symptom improvement by the 16th week, while 54.5% achieved improvements of 50% or more. Investors responded positively to the update, pushing Immunovant’s stock up 20% to over $31.70 in premarket trading Wednesday, compared with Tuesday’s closing price of just under $26.30. The firm noted that IMVT-1402 did well in terms of both safety and tolerability, as there were no big problems identified.
With over $902 million in cash reserves, Immunovant indicated it believes it has sufficient funding to continue developing IMVT-1402 across multiple indications through a potential commercial launch in Graves’ disease.
Having said that, ending batoclimab’s development marks another setback for FcRn inhibitors in TED. argenx previously halted studies of Vyvgart for the condition after signs emerged that the trials were unlikely to achieve their objectives. In batoclimab’s case, doubts had already surfaced after Immunovant abandoned plans to pursue the therapy in myasthenia gravis despite a successful phase 3 outcome in that IgG-driven disease.
Immunovant Scraps FcRn Inhibitor Program
Immunovant has decided to discontinue development of its first-generation FcRn inhibitor following disappointing Phase 3 trial results in thyroid eye disease. The decision marks a significant setback for Immunovant as the company moves away from the batoclimab program after late-stage studies failed to achieve their primary endpoints.
The company confirmed that both Phase 3 studies evaluating batoclimab in patients with thyroid eye disease did not demonstrate the required level of clinical improvement. Despite some positive observations during higher-dose treatment periods, the overall trial results were not strong enough to support continued development.
Immunovant Faces Financial Impact After Trial Failure
Immunovant is also expected to make financial payments connected to the discontinuation of the FcRn inhibitor program. Reports indicate the company agreed to payout obligations linked to its licensing arrangements after ending the batoclimab development effort.
The failed studies triggered negative reactions from analysts and investors, with several firms lowering expectations for the discontinued therapy. Market observers noted that investor confidence had already weakened after competing FcRn inhibitors experienced difficulties in similar indications.
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