Batoclimab

Immunovant’s batoclimab failed in two late-stage trials in thyroid eye disease (TED). It already said it probably wasn’t going to advance the drug further in a similar condition called Graves’ disease. The company said Thursday it would discuss batoclimab’s future with its partner, the South Korean drugmaker HanAll Biopharma. The Phase 3 trials, called GO-1 and GO-2, were designed to show that batoclimab could improve a TED symptom called proptosis, where the patient’s eyes bulge from their sockets. Patients were given a 680 mg injection of the drug every week for three months, followed by half that dose for the same period. At the six-month mark, the proptosis improvement endpoint was not met. Immunovant did say that batoclimab recipients had more of an improvement on the proptosis measure after the study’s high-dose period than they did after the subsequent low-dose period, suggesting a dose response. The company’s shares $IMVT were down by as much as 11% in premarket trading Thursday. Immunovant said in September that it was focusing its Graves’ disease efforts on a next-generation candidate with the same mechanism as batoclimab, known as IMVT-1402. A year ago, it also said it was dropping batoclimab in the autoimmune disorder myasthenia gravis, again in favor of IMVT-1402. Both candidates aim to block the neonatal Fc receptor, which should reduce circulating levels of pathogenic IgG autoantibodies and combat IgG-mediated diseases like TED and Graves. IMVT-1402 is in Phase 2 trials in Graves’ disease, which Immunovant said are potentially registrational. Investors will get the chance to see whether this product works better than its predecessor when the first data from those trials emerge next year. Meanwhile, another company under Roivant’s “vant” umbrella, Priovant, said Thursday it had started a Phase 2b/3 trial of a drug called brepocitinib, which could support the drug’s approval in the scalp condition lichen planopilaris (LPP). In LPP, hair follicles are destroyed and replaced with scar tissue, causing itching or burning sensations and permanent hair loss. The disorder can also increase the risk of other autoimmune diseases and skin cancers. It mostly affects people aged 40 to 60 and is more common in women than men, and Priovant said roughly 100,000 US adults have LPP. There are no approved treatments. Brepocitinib is a dual JAK1/TYK2 inhibitor. It is due an approval decision in the third quarter of this year for the inflammatory condition dermatomyositis. Priovant said it could launch in in September. The drug is also being researched in non-infectious uveitis and cutaneous sarcoidosis. Editor’s note: This article was updated to include Immunovant’s share price change.

Immunovant reported that its FcRn inhibitor batoclimab failed to meet the primary endpoint in a pair of Phase III thyroid eye disease (TED) trials, knocking shares down roughly 8% in premarket trading Thursday. Batoclimab has been on the backburner for some time, however, and the Roivant subsidiary reiterated that it remains focused on advancing its successor anti-FcRn antibody, IMVT-1402, touted as a more optimised therapy for autoimmune diseases.The two TED studies, GO-1 and GO-2, evaluated a 24-week batoclimab regimen consisting of an initial high-dose period followed by a lower-dose phase, but neither achieves a significant ≥2 mm proptosis responder rate at week 24.Topline data revealed a split in efficacy between dosing periods. According to Immunovant, patients experienced greater improvements in proptosis during the first 12 weeks of high-dose treatment than in the subsequent 12-week low-dose phase, suggesting a need for "deeper IgG suppression" in order to maintain clinical benefit.The company also highlighted that a subset of hyperthyroid patients in the trials showed thyroid hormone normalisation rates comparable to those observed in earlier batoclimab testing in Graves' disease. In 2024, it reported results from a Phase IIa Graves' disease study where higher levels of IgG reduction correlated with stronger clinical responses in uncontrolled on antithyroid drugs.Last year, Immunovant announced encouraging Phase III results for batoclimab in myasthenia gravis, but decided against seeking regulatory approval, preferring to focus on IMVT-1402, which Oppenheimer analysts have suggested could displace argenx's first-mover Vyvgart (efgartigimod alfa) "through deep IgG reduction, dosing flexibility tailored for chronic disease, and convenient administration [via] at-home auto-injector."Meanwhile, next steps for batoclimab will be discussed with its partner HanAll Biopharma. Immunovant is advancing IMVT-1402 across several autoimmune indications, including myasthenia gravis and Sjögren's disease. Potentially registrational data in Graves' disease are expected in 2027.