01—Abstract
Summary
Summary of the 8-K filed September 9, 2024. Cited figures are marked; the original filing is the authoritative source.
Roivant Sciences Ltd. furnished this Form 8-K under Item 7.01 (Regulation FD Disclosure) to attach a September 9, 2024 press release, Exhibit 99.1, providing an update on the Graves' disease development program at Immunovant, Inc. (Nasdaq: IMVT).
The release reports Phase 2a trial results for batoclimab in patients who were hyperthyroid despite antithyroid drug (ATD) therapy. Participants first received 12 weeks of high-dose batoclimab (680 mg weekly, subcutaneous), with a mean IgG reduction of 77%a, a 76% response rate, and a 56% ATD-free response rate. During weeks 13 to 24 on the lower 340 mg dose, mean IgG reduction was 65%, with a 68% responder rate and a 36% ATD-free response rate.
Patients who achieved at least a 70%b IgG reduction had a 60% ATD-free response rate, compared with 23% for those who did not. The company also cited real-world claims data indicating that 25-30% of Graves' disease patients per year are uncontrolled on ATDs, with minimal to no existing therapeutic options. Immunovant said it has aligned with the U.S. Food and Drug Administration on a pivotal trial design and that the Investigational New Drug application for IMVT-1402 has been cleared.
It expects to initiate the pivotal trial of IMVT-1402 in Graves' disease by December 31, 2024. Management described the IgG-lowering correlation with clinical outcomes as supporting a potential first-in-class and best-in-class opportunity for IMVT-1402. Under the filing's terms, the information in Item 7.01 and Exhibit 99.1 is furnished and not deemed filed for purposes of Section 18 of the Exchange Act.
02—Key points
Key Highlights
- Batoclimab high-dose arm (680 mg weekly SC, 12 weeks) achieved a 76% response rate and a 56% ATD-free response rate in patients uncontrolled on ATDs.
- Mean IgG reduction was 77% on the high-dose regimen, versus 65% on the lower 340 mg dose during weeks 13 to 24.
- Lower 340 mg dose in weeks 13 to 24 yielded a 68% responder rate and a 36% ATD-free response rate.
- Patients with at least a 70% IgG reduction had a 60% ATD-free response rate, versus 23% for those with less reduction, described as nearly threefold higher.
- Real-world claims data indicate 25-30% of Graves' disease patients per year are uncontrolled on ATDs, with minimal to no existing therapeutic options.
- IND for IMVT-1402 cleared; pivotal trial in Graves' disease expected to initiate by December 31, 2024, following FDA alignment on trial design.
- Information is furnished under Item 7.01 and is not deemed filed under Section 18 of the Exchange Act or incorporated into other SEC filings.
03—Questions
Frequently Asked Questions
What were the main efficacy results of the batoclimab Graves' disease Phase 2a trial?
In the first 12 weeks on high-dose batoclimab (680 mg weekly SC), participants had a mean IgG reduction of 77%, a 76% response rate (T3 and T4 below the upper limit of normal without increasing ATD dose), and a 56% ATD-free response rate (T3 and T4 below the upper limit of normal with complete ATD taper).
How did the lower 340 mg dose perform in weeks 13 to 24?
The 340 mg weekly dose produced a mean IgG reduction of 65% (versus 77% on 680 mg), a 68% responder rate, and a 36% ATD-free response rate during weeks 13 to 24.
What is the relationship between IgG lowering and clinical response?
Patients who achieved at least a 70% IgG reduction by the end of the trial had a 60% ATD-free response rate, compared with 23% for patients who did not reach that level. The company described this correlation as the basis for a potential first-in-class and best-in-class opportunity for IMVT-1402.
What are the next steps for IMVT-1402 in Graves' disease?
Immunovant announced alignment with the FDA on a pivotal trial design and IND clearance, with initiation of the pivotal trial of IMVT-1402 in Graves' disease expected by December 31, 2024.
What market opportunity did the company cite for Graves' disease patients?
Real-world claims data indicate that 25-30% of Graves' disease patients per year are uncontrolled on ATDs, with minimal to no existing therapeutic options, which the company described as an attractive commercial opportunity with limited competition.
04—Continue