Immunovant and Roivant Sciences said Wednesday that their rare disease drug succeeded in a final-phase study, but the duo won't seek regulatory approval for it.
Though patients with myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, or CIDP, showed improvements in their symptoms, Immunovant and Roivant believe they have a better drug in their pipeline. Instead of moving ahead with batoclimab, they will focus on IMVT-1402.
The companies say they are focused on "leveraging data and learnings from the batoclimab studies to inform and accelerate its programs with IMVT-1402.
After initially falling in premarket trades, Immunovant stock rallied and then culled most of its gain, closing up 0.5% at 18.88. Roivant shares also reversed an earlier dive and rose 2.2%, ending the regular session at 10.94.
Roivant, Immunovant Focus On Reducing IgG Levels
Both drugs work by lowering levels of immunoglobulin G, or IgG, an autoantibody tied to a number of immune system conditions.
Patients with myasthenia gravis showed improvements ranging from 4.7 points to 5.6 points after 12 weeks on a 24-point scale measuring activities of daily living. That correlated with a 64% average reduction in IgG levels.
In the CIDP study, patients had an average 1.8-point improvement on a 10-point scale measuring disability due to polyneuropathy, a condition in which damaged nerves can cause weakness, numbness or pain. Of the patients who had a 70% IgG reduction, 84% responded to the treatment.
"Today's results show that deeper IgG reduction leads to deeper responses in MG and CIDP," Immunovant Chief Executive Pete Salzmann said in a written statement. He noted the companies expect the same approach to work in "a wide range of autoantibody mediated conditions."
But Roivant Sciences and Immunovant don't expect to seek approval for batoclimab in myasthenia gravis or CIDP. The companies believe IMVT-1402 will lead to better reductions in IgG levels. They could ask for approval of batoclimab in thyroid eye disease, where it's currently in Phase 3 testing.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
