Batoclimab

Amgen (NASDAQ: AMGN) reported that a Phase III trial of subcutaneous teprotumumab-trbw (Tepezza) delivered via an on-body injector met its primary endpoint in moderate-to-severe active thyroid eye disease, with 76.7% of patients achieving a proptosis response at week 24 versus 19.6% on placebo — a result that positions the reformulation as a potential administration alternative to the already-approved intravenous version. Trial specifics The Phase III TEPEZZA OBI trial is a randomized, double-masked, placebo-controlled, multicenter study enrolling adults with moderate-to-severe active thyroid eye disease, delivering teprotumumab or placebo via on-body injector every 2 weeks for 12 injections over 24 weeks. At week 24, the proptosis responder rate — defined as a ≥2 mm reduction in the study eye without ≥2 mm deterioration in the fellow eye — was 76.7% for the subcutaneous arm versus 19.6% for placebo (p<0.0001). The key secondary endpoint, mean proptosis reduction, was −3.17 mm versus −0.80 mm for placebo (p<0.0001). Additional secondary endpoints, including diplopia response rate, Clinical Activity Score of 0 or 1, and the Graves' Ophthalmopathy Quality of Life appearance subscale, also met statistical significance. The GO-QoL visual functioning subscale showed a numerical trend favoring treatment but did not reach statistical significance. The safety profile was consistent with that of intravenous Tepezza. Mild-to-moderate injection site reactions occurred in some patients but did not lead to treatment interruption or discontinuation. The most common adverse events occurring in ≥10% of patients were muscle spasms, tinnitus, weight decrease, ear discomfort, nausea, and diarrhea — a pattern familiar from the IV formulation’s established label. The development context Teprotumumab is a fully human monoclonal antibody that blocks insulin-like growth factor-1 receptor (IGF-1R) signaling on orbital fibroblasts, the pathway through which autoantibodies drive the inflammation, glycosaminoglycan deposition, and proptosis characteristic of thyroid eye disease. The IV formulation received FDA approval in 2020 as the first and only approved medicine for TED and has since been used in more than 25,000 patients. The subcutaneous program does not alter the molecule or its target; it repackages the same active ingredient into a format that could, if approved, eliminate the requirement for infusion center visits. That distinction matters commercially. The IV regimen involves eight infusions over 24 weeks, with infusion times of about 90 minutes for the first two doses and as little as 60 minutes thereafter if tolerated. For a condition that already imposes substantial functional burden — proptosis, diplopia, and periorbital pain can significantly limit daily activity — the added logistical demand of repeated infusion visits is a recognized friction point. A subcutaneous option delivered via an on-body injector could extend access to patients in geographies without infusion infrastructure and reduce the overall treatment burden, though whether payers and prescribers will view the convenience premium as justifying any additional cost differential remains to be seen. The competitive context for this data is worth examining. Immunovant’s batoclimab, an FcRn inhibitor that reduces pathogenic IgG antibodies rather than directly targeting IGF-1R, failed to meet the primary proptosis endpoint in two Phase III trials in TED. Sling Therapeutics’ linsitinib, an oral small-molecule inhibitor of IGF-1R and the insulin receptor, has reported positive topline results from its Phase II/III LIDS study. Cross-trial comparisons are limited by differences in patient populations, endpoint definitions, and trial designs, but the landscape suggests that direct IGF-1R blockade via teprotumumab retains the most mature efficacy dataset in this indication, and the subcutaneous program extends that dataset without introducing mechanistic uncertainty. Amgen noted separately that a Phase IIIb/IV post-marketing requirement study of intravenous Tepezza — evaluating three treatment durations of 4, 8, and 16 infusions and the need for retreatment — has been completed. That study was descriptive in nature, and its safety observations were consistent with the known IV profile. Data from both studies will be submitted to regulatory authorities and presented at an upcoming medical congress; no regulatory submission timeline for the subcutaneous formulation was disclosed in the topline release. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

This morning’s double trial failure is another blow to attempts to get a FcRn inhibitor approved for thyroid eye disease.\n Immunovant’s first-generation FcRn inhibitor flunked a pair of phase 3 eye disease trials, appearing to end the last hopes of commercializing the drug.The company set out plans back in 2022 to assess the therapy, called batoclimab, in two late-stage studies of patients with thyroid eye disease (TED). This morning, Immunovant’s majority shareholder, Roivant, revealed that both trials had missed their primary endpoint of demonstrating a 2 mm or greater reduction in proptosis—a term for eye bulging—after 12 weekly doses of high-dose batoclimab followed by 12 weeks of a low dose.Patients in the studies were randomized to receive either the treatment or placebo. No new safety signals were identified, Roivant noted.The company pointed out that greater improvements in proptosis were seen after the high-dose period than after the low-dose period. This “support[s] the benefit of deeper IgG suppression,” Roivant concluded. TED is an immunoglobulin G (IgG)-mediated autoimmune condition. When specifically looking at hyperthyroid patients, Roivant said that batoclimab demonstrated thyroid hormone normalization rates similar to those seen in a phase 2 study of the therapy in Graves’ disease, a condition that leads to TED. Batoclimab did score a phase 3 win in March 2025 in myasthenia gravis, another IgG-driven disorder. But by that point, Immunovant had decided not to commercialize batoclimab in this condition. While it already sounded like Immunovant had lost enthusiasm for the asset, the company said at the time that it was holding off making a decision on whether to pursue batoclimab in TED until it saw today’s phase 3 results.The following month, batoclimab’s future sounded even bleaker. As Roivant took tighter control of the spinout by installing its own CEO, the company explained that development activities for the asset could “begin to conclude.”According to this morning’s release, Immunovant now “intends to review future plans for the development of batoclimab” with its Korea-based partner HanAll and provide an update “at a future date.”  TED can cause muscles that control the eye and fat behind the organ to grow abnormally, and it can also lead to orbital inflammation. This can in turn cause proptosis, double vision or, in severe cases, vision loss.This morning’s double trial failure 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 goal.Under a closer alignment with Roivant, Immunovant has been focusing its resources on a second-generation FcRn blocker dubbed IMVT-1402. Topline data from phase 2b studies of IMVT-1402 in Graves’ disease are expected next year, Roivant confirmed in this morning’s release.