HanAll partner Immunovant reports long-term benefit of batoclimab in Graves’ disease trial

HanAll Biopharma’s partner Immunovant said its investigational autoimmune therapy batoclimab (HL161BKN) showed durable benefit in patients with Graves’ disease six months after treatment discontinuation in a phase 2 clinical study.

Graves’ disease is an autoimmune disorder that causes overactivation of the thyroid gland, leading to symptoms such as weight loss, palpitations, and fatigue. 

Antithyroid drugs (ATDs) are the current standard of care, but around 20 to 30 percent of patients experience insufficient response or disease relapse. 

Patients are also at risk of severe complications, including thyroid eye disease (TED), thyroid storm, and cardiovascular events, highlighting a significant unmet medical need.

According to Immunovant, about 80 percent of patients (17 individuals) maintained normal thyroid hormone levels for six months after stopping batoclimab therapy.

Among them, half (eight patients) were able to sustain stable hormone levels without antithyroid drugs, while 30 percent (five patients) maintained stability with only low doses of ATDs. Safety and tolerability were consistent with prior studies.

The company said the results mark the first evidence that batoclimab may provide long-term disease control even after treatment cessation, potentially offering a new therapeutic approach for patients who do not respond to existing therapies. 

If confirmed in future studies, the findings could represent a major advance in the treatment of Graves’ disease.

In parallel, Immunovant is developing a next-generation FcRn inhibitor, imdevimab (HL161ANS, IMVT-1402), in two global phase 2 registration studies for Graves’ disease, with top-line data expected by 2027. 

HanAll Biopharma CEO Jeong Seung-won welcomed the phase 2 data, calling it a milestone for the program. 

“This dataset is highly meaningful as the first demonstration of disease control potential with batoclimab in Graves’ disease,” Jeong said. “We look forward to upcoming clinical results that may establish a new treatment paradigm and deliver innovative options for patients and physicians.”