STAT+: Immunovant and Roivant report success in autoimmune drug’s Phase 3 trial
The companies reported Wednesday that batoclimab showed improvements in myasthenia gravis patients in a Phase 3 trial.
An antibody treatment from Immunovant and Roivant Sciences significantly reduced symptoms and disease activity in patients with generalized myasthenia gravis, a debilitating autoimmune disease — achieving the goals of a Phase 3 clinical trial, the companies reported Wednesday.
In the study, patients treated with low and high doses of the drug, called batoclimab, showed 4.7-point and 5.6-point improvements, respectively, on a patient-reported symptoms and activity scale called MG-ADL. Participants offered a placebo showed a 3.6-point improvement on the same scale. The benefit for both doses of batoclimab over placebo was statistically significant.
“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, in an interview with STAT. (Immunovant was spun out of Roivant, which still retains 57% ownership.)
