Immunovant starts phase 3 trial of batoclimab to treat myasthenia gravis

Immunovant Sciences, the U.S. partner of Hanall Biopharma, is speeding up a phase 3 trial of HL161 (batoclimab), an autoimmune disease treatment candidate that it licensed from Hanall.

Hanall Biopharma said Immunovant started the phase 3 study of HL161 (Immunovant’s pipeline name: IMVT-1401) to treat myasthenia gravis (MG). Immunovant is developing HL161 as a subcutaneous injection.

Hanall Biopharma hoped that the U.S. trial could accelerate the global studies of HL161.

Last year, Immunovant voluntarily suspended the phase 2b trial of HL161 in thyroid eye disease (TED) after some patients reported an increase in LDL cholesterol levels. After revisions to the clinical monitoring program with expert advice and analysis, the company had additional talks with the FDA and obtained the nod to resume the trial.

Immunovant will conduct the MG trial for 24 weeks – induction period for 12 weeks and maintenance period for another 12 weeks.

During the induction period, MG patients will be divided into three groups each receiving batoclimab 680mg, 340mg, and a placebo once a week for 12 weeks.

During the maintenance period, researchers will administer the low-dose batoclimab 340mg once a week or once every two weeks to measure the maintenance effect of the treatment.

The primary endpoint was set as the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.

Hanall Biopharma also aims to initiate a phase 3 MG trial in Japan in the second half of this year.