Immunovant has reshuffled plans for two of its anti-FcRn antibody drugs.
The company has delayed clinical readouts by several months for its late-stage FcRn inhibitor, called batoclimab, on the heels of a Type B meeting with the FDA. Meanwhile, it said it would prioritize registrational development of another FcRn candidate, named IMVT-1402, that could offer a better risk-benefit profile.
For IMVT-1402, which is currently in Phase 1 development, the company plans to start four to five “potentially registrational programs” across a range of endocrinology, neurology and other indications by March next year, according to its fiscal year earnings release Wednesday.
As for batoclimab, Phase 3 results in myasthenia gravis have been deferred to the first quarter of next year from an original target of the second half of 2024. Also, data from the Phase 2b trial in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) are now expected in the first quarter of 2025, which is a delay from the previous guidance of Q3 or Q4 this year.
Immunovant said it has decided to wait longer before unblinding period 1 of the Phase 2b batoclimab trial in CIDP to ensure the results can help better “optimize” the design of a forthcoming IMVT-1402 investigation in the same autoimmune disorder.
The company said it “expects to achieve financial efficiencies” in its development of IMVT-1402 by “taking advantage of batoclimab data and by applying learning from publicly disclosed in-class competitor data and trial designs.” Batoclimab and IMVT-1402 share the same target and mechanism.
“Taken together, we think the move to glean as much information as possible from the ongoing batoclimab studies makes sense given that the most important value-driver for [Immunovant] moving forward is IMVT-1402,” Stifel analysts said in a Wednesday note.
Immunovant’s share price $IMVT is down around 6% to $27.80 premarket Thursday.
In November, the company said that IMVT-1402 has “best-in-class” potential after sharing results from healthy volunteers showing the drug reduced total IgG by more than 70% — a level similar to what batoclimab achieved but with more of a placebo-like impact on albumin and LDL-C levels.
IMTV-1402 is differentiated from other drugs of its class due to its potential for deeper lowering of IgG and a more “favorable analyte profile,” according to a company presentation.
Competition in the FcRn space is heating up after argenx unveiled plans last year to test at least 14 more autoimmune indications for its first-in-class product Vyvgart by 2025. Vyvgart was first greenlit in the US for certain patients with generalized myasthenia gravis in 2021. Meanwhile, Johnson & Johnson is also advancing its Phase 3 candidate, named nipocalimab, which it obtained in its $6.5 billion buyout of Momenta back in August 2020. And earlier this week, Biohaven released details on its own drug that targets IgG levels, but the data disappointed investors who were hoping for a stronger effect.
IMVT-1402 offers a relatively more convenient subcutaneous dosing versus Vyvgart and nipocalimab’s intravenous method. Vyvgart is also available in a subcutaneous formulation as Vyvgart Hytrulo.
Editor’s note: This story has been updated to mention Biohaven’s results from earlier this week.