HanAll Biopharma Demonstrates Efficacy of Batoclimab in Myasthenia Gravis Phase 3 Clinical Trial

"Phase 3 Clinical Trial Results for Thyroid Eye Disease to Be Announced in the Second Half Are Also Highly Anticipated"

HanAll Biopharma's U.S. partner Immunovant announced on the 19th (local time) that Batoclimab demonstrated efficacy in the Phase 3 clinical trial for myasthenia gravis and the Phase 2b clinical trial for chronic inflammatory demyelinating polyneuropathy.

HanAll Biopharma

Batoclimab is an antibody drug independently developed by HanAll Biopharma. In 2017, the rights for the U.S. and Europe were licensed out to Roivant. Since then, Roivant established its subsidiary Immunovant to continue the development of Batoclimab.

The Phase 3 clinical trial for Batoclimab in myasthenia gravis was conducted over a total of 24 weeks (12 weeks induction phase, 12 weeks maintenance phase) on patients with myasthenia gravis. Batoclimab doses of 680 mg, 340 mg, or placebo were administered once weekly for 12 weeks to induce rapid symptom improvement. Subsequently, a low dose of 340 mg was administered either once weekly or once every two weeks for 12 weeks to assess the maintenance effect of the treatment. The primary endpoint was the evaluation of "activities of daily living," which measures symptom improvement as perceived by patients with myasthenia gravis.

Clinical results showed that the MG-ADL score improved by an average of 5.6 points (p<0.001) in the high-dose Batoclimab group and by an average of 4.7 points (p<0.05) in the low-dose group, demonstrating a significant difference compared to placebo. Notably, the high-dose group exhibited a high average antibody reduction rate of 74%, confirming superior efficacy compared to competitors. Additionally, the proportion of patients with an improvement of 2 points or more in the Batoclimab MG-ADL score reached 93% in the high-dose group and 81% in the low-dose group.

The Phase 2b clinical trial for chronic inflammatory demyelinating polyneuropathy (CIDP) compared the effects in patient groups administered two different doses of Batoclimab. The goal was to verify the neurological function improvement effect of Batoclimab using aINCAT in CIDP patients. The study results showed an average improvement of 1.8 points in the Batoclimab group after discontinuing standard treatment, and 84% of patients with over 70% antibody reduction in the body demonstrated improved aINCAT response rates.

HanAll Biopharma plans to carefully analyze the Phase 3 clinical trial for myasthenia gravis and establish plans for Batoclimab approval in Japan.

Seungwon Jung, CEO of HanAll Biopharma, stated, "We are encouraged by the positive results of this Phase 3 clinical trial for myasthenia gravis, and we also look forward to the results of the Phase 3 clinical trial for thyroid eye disease to be announced in the second half of this year." He added, "These Phase 3 clinical trial results will serve as a stepping stone for HanAll and Immunovant's pursuit of expanding the indications for Batoclimab and HL161ANS."