HanAll Biopharma, a subsidiary of Daewoong Pharmaceutical, is ramping up its efforts to target Graves’ disease (GD) with its next-generation FcRn inhibitor, Imeroprubart, leveraging clinical data from Batoclimab.
Industry sources reported on Tuesday that Imeroprubart is engineered to reduce IgG autoantibodies, key players in autoimmune diseases, while minimizing effects on albumin, a crucial blood protein.
This innovative drug is considered a promising candidate, potentially offering both potent antibody suppression and a favorable safety profile.
Developed as a subcutaneous injection using an auto-injector, Imeroprubart allows for easy self-administration without medical supervision. This combination of efficacy, safety, and user-friendliness positions it as a potential best-in-class therapy.
Imeroprubart is currently being developed for six autoimmune conditions, including Graves’ disease, through HanAll’s partner, Immunovant. Clinical development is particularly focused on Graves’ disease as a primary indication.
Immunovant has prioritized the launch of Imeroprubart for Graves’ disease in 2028, with two ongoing registration trials. The company anticipates releasing topline results in 2027.
In this context, clinical outcomes from Batoclimab, the predecessor compound, are garnering attention as they suggest Imeroprubart’s potential in treating Graves’ disease. Notably, Batoclimab showed significant therapeutic benefits in Phase 2 trials for Graves’ disease.
After a 24-week Batoclimab treatment course, 72% of patients previously unresponsive to standard antithyroid drugs showed positive treatment responses.
At the 24-week post-treatment mark, 80% of patients maintained normal thyroid hormone levels, with half remaining stable without antithyroid medication.
Among patients receiving high-dose Batoclimab, 60% achieved normal hormone levels by week 12 and discontinued antithyroid medication. Levels of thyroid-stimulating autoantibodies (TRAb) remained suppressed even after treatment cessation.
In a recent Phase 3 trial of Batoclimab for thyroid eye disease (TED), while the primary endpoint of proptosis improvement wasn’t met, 80% of patients with hyperthyroidism achieved normal thyroid hormone levels after high-dose treatment.
Industry experts view these results as potentially indicative of success in future Graves’ disease trials, where key metrics include the proportion of patients achieving hormone normalization or discontinuing antithyroid medication.
A HanAll spokesperson stated that Imeroprubart shows great promise as a leading therapy in its class, offering potent IgG reduction, a strong safety profile, and the convenience of auto-injector administration.
They added that beginning with key indication data to be released this year, it anticipates demonstrating Imeroprubart’s competitive edge through topline results in 2027 and Graves’ disease data supporting the targeted 2028 launch.