Immunovant Shifts Focus to Next-Gen Drug Despite Positive Phase 3 Results for Batoclimab in Myasthenia Gravis
Immunovant reported positive Phase 3 results for batoclimab in myasthenia gravis (MG), meeting its primary endpoint12.
The high-dose arm (680mg) showed a 5.6-point improvement in MG-ADL score, while the low-dose arm (340mg) demonstrated a 4.7-point improvement25.
Despite the positive results, Immunovant will not seek regulatory approval for batoclimab in MG or chronic inflammatory demyelinating polyneuropathy (CIDP)14.
The company is shifting focus to its lead asset IMVT-1402, a next-generation FcRn inhibitor34.
Immunovant plans to initiate pivotal studies for IMVT-1402 in both MG and CIDP, leveraging data and learnings from the batoclimab studies45.
The decision to not pursue approval for batoclimab is attributed to competitive pressures in the FcRn inhibitor space3.
Batoclimab still has ongoing Phase 3 studies in thyroid eye disease, with Immunovant waiting for those results before making decisions on potential regulatory submissions34.
The company's strategy aligns with its core thesis that deeper IgG reduction leads to improved clinical outcomes in autoantibody-mediated conditions25.
Sources:
1. https://endpts.com/immunovant-will-not-take-immune-drug-to-regulators-despite-phase-3-success/
2. https://www.stocktitan.net/news/IMVT/immunovant-announces-positive-results-for-batoclimab-myasthenia-0uatd4vyuh8u.html
3. https://www.biospace.com/drug-development/immunovant-will-drop-one-myasthenia-gravis-asset-continuing-to-favor-another
4. https://in.benzinga.com/general/biotech/25/03/44401719/immunovant-ditches-seeking-fda-approval-for-batoclimab-for-two-autoimmune-disorders-despite-positive-phase-3-data
5. https://www.immunovant.com/investors/news-events/press-releases/detail/71/immunovant-announces-positive-results-for-batoclimab