Harbour BioMed, HanAll Biopharma’s Chinese partner, announced on the 22nd that it is currently conducting Phase 1b/2a clinical trials in China to verify the efficacy and safety of Batoclimab subcutaneous injection in acute neuromyelitis optica spectrum disorder (NMOSD) patients and has begun the first patient administrations for the trial.
Batoclimab is the international non-proprietary name (INN) of the HL161 novel antibody drug (Harbour BioMed Code Name: HBM9161; Immunovant Code Name: IMVT-1401), which is being globally developed by HanAll Biopharma jointly with Harbour BioMed of China and Immunovant of the U.S.
With no established treatment available, a high-dose steroid is generally used in the treatment of NMOSD. For patients with severe NMOSD, immunoglobulin, a blood component, is intravenously injected (IVIG), or plasmapheresis, which filters out autoantibodies from the patient’s blood to inject it back into the patient, is administered. Batoclimab is a subcutaneous injection product that is convenient to administer. It is drawing anticipation as a new drug to effectively remove the AQP autoantibody, the cause of the disease.
Harbour BioMed anticipates the release of Batoclimab in the Chinese market ahead of the competing products. In addition to NMOSD, it plans to concurrently conduct clinical trials for immune thrombocytopenic purpura (ITP), thyroid eye disease (TED), and myasthenia gravis (MG).
Separately from the clinical trials in China, Immunovant, HanAll Biopharma’s global partner, announced positive Phase 2a clinical trial results for Batoclimab for TED at the end of March. It is also conducting Phase 2 clinical trials in the U.S. and Europe in relation to MG and warm antibody autoimmune hemolytic anemia (WAIHA).