HanAll Biopharma's Autoimmune Disease Therapy 'HL161' Shows Six-Month Maintenance Effect in Phase 2 Trial
by Jeong Donghoon
Published 04 Sep.2025 08:34(KST)
Batoclimab Maintains Normal Thyroid Hormone Levels
in Approximately 80% of Patients After Treatment Completion
Immunovant, a partner of HanAll Biopharma, announced on September 3 (local time) data on the six-month maintenance effect after completion of treatment with batoclimab (HL161BKN), an autoimmune disease therapy, in a Phase 2 clinical trial for Graves' disease.
Graves' disease is an autoimmune disorder in which the immune system malfunctions and excessively activates thyroid function. It causes a variety of symptoms, including weight loss, palpitations, and fatigue. Currently, anti-thyroid drugs (ATDs) are used as the standard treatment, but about 20-30% of patients do not respond sufficiently or experience relapse. There is also a risk of developing complications such as thyroid eye disease (TED), thyroid storm, and cardiovascular disease (CV), resulting in significant unmet needs for patients.
According to the results of this clinical trial, about 80% (17 patients) maintained normal thyroid hormone levels for six months after completing batoclimab treatment. Among them, about 50% (8 patients) maintained stable hormone levels without anti-thyroid drugs, and 30% (5 patients) remained stable while taking a small amount of anti-thyroid drugs. The safety and tolerability profile was consistent with previous studies.
This data represents the first case to suggest the potential of batoclimab as a fundamental long-term treatment for patients who did not respond to existing therapies. If consistent results are obtained in future clinical trials, it is expected to bring a groundbreaking change to the treatment of Graves' disease.
Meanwhile, Immunovant is conducting two global registrational Phase 2 clinical trials targeting Graves' disease with its next-generation FcRn inhibitor, imlifidase (HL161ANS, IMVT-1402), and plans to announce topline results by 2027. Results from the Phase 3 clinical trial of batoclimab for thyroid eye disease are expected to be released by the end of this year.
Jung Seungwon, CEO of HanAll Biopharma, stated, "This data is highly significant as it is the first case to demonstrate the potential for disease control with HL161 in Graves' disease. We hope that the upcoming clinical results will present a new treatment paradigm and provide innovative therapeutic options for both patients and healthcare professionals."
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