01—Abstract
Summary
Summary of the 8-K filed March 19, 2025. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. (ROIV) furnished this Form 8-K on March 19, 2025 to report an update on the myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) programs at its subsidiary, Immunovant, Inc. (Nasdaq: IMVT).
The press release (Exhibit 99.1) states that the Phase 3 MG study of batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants at Week 12: a 5.6-point improvement at the 680mg weekly dose (74%a mean IgG reduction), a 4.7-point improvement at 340mg weekly (64% mean IgG reduction), and a 3.6-point improvement with placebo. Initial pooled Period 1 data from the Phase 2b CIDP study, covering 73 patients, showed a 1.8-point mean improvement in adjusted INCAT at Week 12 and an 84% responder rate among patients with IgG reduction of at least 70%. Immunovant stated that it does not currently intend to seek regulatory approval for batoclimab in MG or CIDP.
It will instead focus on its lead asset, IMVT-1402, and plans to begin potentially registrational studies in both indications, with INDs cleared for both. The final decision on batoclimab regulatory submissions will wait for results from the ongoing Phase 3 thyroid eye disease studies. The CIDP study has not been unblinded, so no primary endpoint data from Period 2 are available yet.
The filing also includes a presentation (Exhibit 99.2) that describes safety as consistent with prior batoclimab studies, reports treatment-related serious TEAEs in 2 of 57 patients on 680mg (3.5%b) and one death in the placebo arm, and includes cross-trial comparisons with other FcRn inhibitors. The company itself cautions that these comparisons are not head-to-head.
02—Key points
Key Highlights
- Phase 3 MG study of batoclimab met its primary endpoint: MG-ADL improvement of 5.6 points at 680mg weekly and 4.7 points at 340mg weekly, versus 3.6 points with placebo, at Week 12.
- Minimal Symptom Expression at Week 12 was 42% with 680mg and 31% with 340mg, compared with 7% with placebo, in the AChR+ population.
- Initial CIDP Period 1 data (73 patients pooled) showed a 1.8-point mean aINCAT improvement at Week 12 and an 84% responder rate among patients with IgG reduction of at least 70%.
- Immunovant does not intend to seek regulatory approval for batoclimab in MG or CIDP at present, shifting focus to IMVT-1402.
- Immunovant plans to start potentially registrational studies of IMVT-1402 in MG and CIDP, with INDs cleared for both indications; a final decision on batoclimab submissions awaits Phase 3 thyroid eye disease results.
- Safety was reported as consistent with prior batoclimab studies; treatment-related serious TEAEs occurred in 2 patients (3.5%) on 680mg and 1 in the 340mg arm (1.9%).
03—Questions
Frequently Asked Questions
Did the batoclimab MG Phase 3 study succeed?
Yes. The study met its primary endpoint, showing a mean change from baseline in MG-ADL in AChR+ participants at Week 12. The 680mg arm improved 5.6 points and the 340mg arm improved 4.7 points, compared with 3.6 points for placebo.
Will Immunovant seek approval for batoclimab in MG or CIDP?
Not at present. Immunovant says it does not plan to seek regulatory approval for batoclimab in these indications and will focus on IMVT-1402. It will decide on batoclimab regulatory submissions after Phase 3 thyroid eye disease results are available.
What comes next for IMVT-1402?
Immunovant plans to begin potentially registrational studies of IMVT-1402 in MG and CIDP, and says the INDs for both indications have been cleared. The filing describes the MG study design as including an induction period, a maintenance period, and a long-term extension.
What are the limitations of the CIDP data?
The CIDP Phase 2b study is ongoing and has not been unblinded. The reported data are pooled Period 1 results from 73 patients, and no primary endpoint data from Period 2 are available yet.
04—Continue