Immunovant's batoclimab failed to meet the primary endpoint of proptosis responder rate in two Phase 3 trials for thyroid eye disease (TED). 6
Safety results were consistent with prior studies, but the failures validate biotechs' shift away from batoclimab toward next-generation IMVT-1402. 26
Immunovant succeeded in Phase 3 for myasthenia gravis (MG) with batoclimab hitting primary endpoint and superior IgG reductions, yet chose not to pursue approval, focusing on IMVT-1402. 23
Decision on batoclimab in TED remains pending after Phase 3 data, amid waning interest. 2
Earlier proof-of-concept showed promise in TED with IgG reductions and proptosis improvements, but Phase 3 did not confirm efficacy. 1
Sources:
1. https://pmc.ncbi.nlm.nih.gov/articles/PMC10655547/
2. https://www.fiercebiotech.com/biotech/immunovant-posts-phase-3-autoimmune-win-wont-seek-approval
3. https://www.immunovant.com/investors/sec-filings/all-sec-filings/content/0001764013-25-000037/0001764013-25-000037.pdf