Efgartigimod Alfa

Immunovant reported preliminary Week 16 data for its FcRn inhibitor IMVT-1402 in heavily pretreated rheumatoid arthritis patients, with ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively, according to results disclosed alongside the company’s fiscal year 2026 financial results. The data arrive weeks after Immunovant discontinued development of batoclimab following failed Phase III thyroid eye disease studies, increasing investor focus on IMVT-1402 as the company’s lead FcRn inhibitor franchise. The open-label study enrolled adults with difficult-to-treat rheumatoid arthritis who had failed at least two prior advanced therapies, including biologic and targeted synthetic DMARDs. Among 165 evaluable participants, response rates remained consistent in a subgroup previously treated with both JAK and anti-TNF inhibitors. The IMVT-1402 rheumatoid arthritis study is a two-period trial enrolling heavily pretreated adults with difficult-to-treat rheumatoid arthritis who have failed at least two prior mechanisms of advanced therapy, including biologic and targeted synthetic DMARDs. Period 1 is an open-label, 16-week phase in which all 170 enrolled participants received IMVT-1402 600 mg weekly by subcutaneous injection. Of the 170 enrolled, 165 were evaluable at Week 16. The primary endpoint for the trial is the proportion of Period 1 ACR20 responders who maintain that response at Week 28. At Week 16, the observed ACR20, ACR50, and ACR70 response rates across the 165 evaluable participants were 72.7%, 54.5%, and 35.8%, respectively, with participants who discontinued before Week 16 counted as non-responders. Within the subset of 107 participants who had failed at least one JAK inhibitor and at least one anti-TNF inhibitor — a group representing a particularly refractory population — the ACR20, ACR50, and ACR70 rates were 72.0%, 53.3%, and 37.4%, respectively, showing minimal attenuation compared to the overall cohort. IMVT-1402 was described as safe and well-tolerated, with no new drug-related safety signals identified during Period 1. These are preliminary, open-label data from a single-arm period, and the absence of a concurrent placebo arm limits direct causal interpretation. The randomized Period 2, with topline data expected in the H2 2026, will provide the controlled evidence needed to assess whether response is maintained and whether dose differentiation emerges between the 600 mg and 300 mg cohorts. IMVT-1402 is an FcRn-targeting monoclonal antibody that blocks neonatal Fc receptor-mediated IgG recycling, accelerating lysosomal degradation of circulating IgG autoantibodies. The rationale in difficult-to-treat rheumatoid arthritis rests on the IgG-driven inflammatory pathology that persists in patients who have exhausted conventional biologic and targeted synthetic DMARD options. The FcRn inhibitor class has established proof of concept in other IgG-mediated autoimmune diseases. argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) and UCB’s Rystiggo (rozanolixizumab) are both approved in generalized myasthenia gravis, demonstrating meaningful IgG reduction and clinical benefit in antibody-driven disease. Neither has an approved indication in rheumatoid arthritis, and the application of FcRn inhibition to D2T RA remains investigational. Immunovant clinical trial data from the D2T RA program are particularly relevant in the context of the company’s recent pipeline setback. In April 2026, Immunovant disclosed that two Phase III studies of batoclimab in active, moderate-to-severe thyroid eye disease failed to meet their primary endpoints, prompting discontinuation of batoclimab development across all indications. The company stated that clinical data, operational experience, and investigator relationships from the batoclimab program have been applied to inform IMVT-1402 development. IMVT-1402 is described as having a potentially improved albumin-sparing profile relative to batoclimab, a differentiation the company has cited as supporting broader chronic use across multiple autoimmune indications. Beyond the D2T RA program, Immunovant reported that its proof-of-concept trial evaluating IMVT-1402 in cutaneous lupus erythematosus has completed enrollment, with topline data also expected in the second half of calendar year 2026. The IMVT-1402 cutaneous lupus study adds to a pipeline that now spans five active autoimmune indications, including potentially registrational trials in Graves’ disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease — all of which the company said remain on track. The Immunovant financial results release noted that the company’s current cash position provides runway to the potential launch of IMVT-1402 in Graves’ disease, with topline data from the potentially registrational trials in Graves’ disease and myasthenia gravis expected in calendar year 2027. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

In this morning’s first-quarter earnings release, Immunovant confirmed that the road has run out for batoclimab. \n Immunovant has confirmed that its first-generation FcRn inhibitor has been scrapped, a month after the asset flunked a pair of phase 3 eye disease trials.The company first set out plans back in 2022 to assess the therapy, called batoclimab, in two late-stage studies of patients with thyroid eye disease (TED). But Immunovant’s majority shareholder, Roivant, disclosed in early April that both trials had missed their primary endpoint of demonstrating a 2 mm or greater reduction in proptosis, a term for eye bulging.TED is an immunoglobulin G (IgG)-mediated autoimmune condition. Last month, Roivant suggested that greater improvements in proptosis were seen after the high-dose period in the studies than after the low-dose period, meaning the data support “the benefit of deeper IgG suppression.”The company didn’t appear willing to write off batoclimab completely, only saying in its April statement that it intended to “review future plans for the development of batoclimab” with its Korea-based partner, HanAll, and that it would provide an update “at a future date.”  But in this morning’s first-quarter earnings release, Immunovant confirmed that the road has run out for batoclimab. The biotech also noted that discontinuing the program had resulted in paying out $39 million in related contractual costs. These helped drive up R&D expenses for the fiscal year ending March 31 to $456.7 million compared with $360.9 million for the previous-year period.Immunovant tried not to paint batoclimab as a totally wasted effort. Instead, the company said that learnings from the program, including its “clinical data, operational trial experience and relationships with investigators,” could be “leveraged to inform the development” of its second-generation FcRn blocker, IMVT-1402.Topline data from a proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus are expected in the second half of this year, while a readout for a phase 2b study in Graves’ disease is penciled in for next year and a study in difficult-to-treat rheumatoid arthritis (RA) is also ongoing.The company offered a slice of preliminary data from the RA study this morning, which showed that 72.7% of the study’s 170 heavily pre-treated patients had seen at least a 20% improvement in symptoms at Week 16, with 54.5% seeing a 50% or greater improvement. Investors appeared enthused by the findings, sending Immunovant’s stock up 20% to $31.71 in pre-market trading Wednesday from a Tuesday closing price of $26.29.With $902.1 million in the bank, Immunovant said it has enough cash to continue to explore each of these indications up to a hoped-for commercial launch of IMVT-1402 in Graves’ disease.Still, scrapping batoclimab is another blow to attempts to get an FcRn inhibitor approved for TED after argenx discontinued studies of Vyvgart for the eye condition after they appeared set to miss their goals. The writing had been on the wall for batoclimab for a while, with Immunovant having written off any chances of pursuing the drug to treat myasthenia gravis despite the drug notching a phase 3 win for the IgG-driven disorder.