Daewoong Pharmaceutical announced on Thursday that its subsidiary, HanAll Biopharma, failed to achieve statistical significance in the topline results of a Phase 3 clinical trial evaluating batoclimab in patients with Thyroid Eye Disease (TED).
Batoclimab, a compound developed by HanAll Biopharma, was licensed to Roivant in 2017.
The study assessed batoclimab’s effects in adult patients with active TED, comparing high-dose (680 mg) and low-dose (340 mg) administrations over 12 weeks each. The primary endpoint, the proptosis responder rate at 24 weeks, was not statistically significant.
Safety and tolerability profiles were consistent with those from previous Phase 3 trials in myasthenia gravis and Phase 2 trials in Graves’ disease, with no new serious adverse effects reported.
The high-dose group showed greater improvement in eye protrusion compared with the low-dose group over the 12-week period, suggesting a correlation between antibody reduction and clinical efficacy.
Notably, in TED patients with concurrent hyperthyroidism, high-dose treatment normalized thyroid hormone levels, mirroring results from earlier Graves’ disease Phase 2 trials.
HanAll’s global partner, Immunovant, is accelerating the clinical development of imemoprubat, HanAll’s next-generation product, with a strategic focus on Graves’ disease.
Imeroprubart shows promise as a potential best-in-class treatment, offering differentiated antibody reduction without affecting albumin levels. It features an auto-injector for convenient single-button administration, enhancing its appeal in efficacy, side-effect profile, and user-friendliness.
Immunovant is currently conducting clinical trials for Imeroprubart across six indications. Results for refractory rheumatoid arthritis (D2T-RA) and cutaneous lupus erythematosus (CLE) are expected this year.
Looking ahead to next year, the company anticipates data from two pivotal trials for Graves’ disease.