Immunovant, a partner of HANALL BIOPHARMA, announced on the 3rd (local time) that it has confirmed the maintenance effect for six months after treatment in a Phase 2 clinical trial of vato-climab (HL161BKN) for patients with Graves' disease, which is being developed as a treatment for autoimmune diseases.
Graves' disease is an autoimmune disorder caused by an abnormal immune system, leading to excessive activation of thyroid gland function, which causes various symptoms such as weight loss, heart palpitations, and fatigue.
Currently, antithyroid drugs (ATD) are used as standard treatment, but about 20-30% of patients are reported to have insufficient treatment effects or experience relapses. There is also a risk of complications such as thyroid eye disease (TED), thyroid storm, and cardiovascular diseases, so many patients are waiting for new treatments.
According to the results of this clinical trial, approximately 80% (17 people) of patients maintained normal thyroid hormone levels for six months after the conclusion of vato-climab treatment.
Of these, about 50% (8 people) maintained stable hormone levels without antithyroid drugs, while 30% (5 people) maintained a stable condition while taking a small amount of antithyroid drugs. Safety and tolerability were consistently confirmed with previous studies.
The company noted, "If consistent results emerge in future clinical trials, it is expected to bring a groundbreaking shift in the treatment of Graves' disease."
Vato-climab is an antibody drug that removes pathogenic autoantibodies, which are the cause of autoimmune diseases. It mainly inhibits FcRn (neonatal Fc receptor), which is involved in antibody reabsorption.
Jeong Seung-won, CEO of HANALL BIOPHARMA, stated, "This data is significant as it represents the first case demonstrating the disease control potential of HL161BKN in Graves' disease," and added, "We hope to present a new treatment paradigm through the upcoming clinical results and provide innovative treatment options to both patients and medical staff."
Immunovant is also conducting two global clinical trials targeting Graves' disease based on the next-generation FcRn inhibitor imeropruvate (HL161ANS, IMVT-1402). They plan to announce the primary analysis results of the clinical trials by 2027. The results of the Phase 3 clinical trial targeting thyroid eye disease using vato-climab are expected to be announced by the end of this year.