Immunovant has announced it will discontinue development of its anti-FcRn antibody batoclimab for myasthenia gravis (MG) despite achieving positive results in a Phase III clinical trial. The decision comes as the company shifts its focus to its next-generation therapy, IMVT-1402.
The Phase III trial data showed that after 12 weeks of treatment, patients receiving high-dose batoclimab experienced a 5.6-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, while the low-dose group showed a 4.7-point improvement. Patients in the placebo arm demonstrated a 3.6-point improvement. Both dosing regimens achieved statistically significant benefits over placebo.
"I feel fantastic about the quality of the dose response and I feel fantastic about the quality of the efficacy data," said Roivant CEO Matt Gline. Roivant Sciences, which spun out Immunovant, still maintains 57% ownership of the company.
Market Dynamics and Strategic Pivot
Despite the positive clinical outcomes, Immunovant confirmed it will not submit batoclimab for regulatory approval in either myasthenia gravis or chronic inflammatory demyelinating polyneuropathy (CIDP). This decision reflects the company's response to competitive pressures in the anti-FcRn landscape, particularly from established therapies like Argenx's Vyvgart.
According to analysts at Leerink Partners, batoclimab's efficacy was "approaching the highest we have observed for any approved or developmental biologic therapy in MG." However, they noted that the results ultimately support Immunovant's strategic emphasis on IMVT-1402, which has already received clearance for clinical testing.
The announcement initially caused volatility in Immunovant's stock, with shares dropping approximately $5 in value before recovering to $20.27 by mid-morning trading, representing an 8% increase over the previous day's close.
The Path Forward with IMVT-1402
Immunovant stated that it will apply learnings from the batoclimab clinical program to accelerate development of IMVT-1402. The company expects to launch pivotal trials for this next-generation anti-FcRn antibody "imminently" in both myasthenia gravis and CIDP.
The strategic shift had been telegraphed by the company last year when it began prioritizing IMVT-1402 over batoclimab. The newer compound is expected to offer potential advantages over first-generation anti-FcRn antibodies, though specific differentiating features have not been fully detailed.
Remaining Opportunity for Batoclimab
While Immunovant is discontinuing batoclimab development for MG and CIDP, the drug still has one remaining opportunity to reach the market. The company continues to await Phase III study results in thyroid eye disease, another autoimmune condition where targeted therapies are needed.
Myasthenia gravis is a chronic autoimmune neuromuscular disorder characterized by varying degrees of weakness in skeletal muscles. The disease affects approximately 14-20 per 100,000 people globally, with patients experiencing debilitating symptoms including muscle weakness, fatigue, and difficulties with basic activities of daily living.
