High-dose group achieves 92.5% ACR20 response rate at week 28, demonstrating statistical significance over placebo. Discussions with the FDA regarding follow-up development are scheduled for later this year, with results for Graves' disease and myasthenia gravis expected in 2027.
HanAll Biopharma announced that its autoimmune disease drug candidate, IMVT-1402 (batoclimab), has met its primary endpoint in a clinical trial for drug-resistant rheumatoid arthritis (D2T RA). In patients who failed to achieve sufficient symptom improvement with existing targeted therapies, the high-dose group showed a statistically significant improvement in treatment response compared to the placebo group.
HanAll Biopharma stated on the 10th that its global partner, Immunovant, disclosed these results during its quarterly earnings call on the 9th (U.S. local time). In the second phase of the trial, the ACR20 response rate for the high-dose IMVT-1402 group at week 28 was 92.5%, surpassing the 75.6% observed in the placebo group (p=0.0139). ACR20 served as the primary endpoint for this study.
The trial focused on patients with highly refractory arthritis who had failed to respond to at least two different targeted therapies with distinct mechanisms of action. In the first phase, patients received 600mg of IMVT-1402 for 16 weeks. Responders were then randomized into high-dose (600mg), low-dose (300mg), and placebo groups for an additional 12 weeks.
Previously reported ACR20, 50, and 70 response rates at week 16 were 72.7%, 54.5%, and 35.8%, respectively. In the second phase, the exploratory ACR50 and ACR70 response rates for the high-dose group reached 80% and 52.5% at week 28.
Treatment response was also observed in patients who had previously failed both JAK inhibitors and TNF inhibitors. These patients showed ACR20, 50, and 70 response rates of 92%, 76%, and 56% at week 28, consistent with the overall patient population.
However, the trial did not reach statistical significance for secondary endpoints. Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) scores showed a trend toward stability compared to the placebo group but failed to reach statistical significance.
Regarding safety, the drug was generally well-tolerated, with no serious adverse events or treatment discontinuations reported due to adverse reactions. Immunovant plans to discuss follow-up development plans for the D2T RA indication with the U.S. Food and Drug Administration (FDA) later this year.
Clinical results for other indications are expected to be released sequentially. Key results for Graves' disease (GD) and myasthenia gravis (MG) are slated for 2027, while data for chronic inflammatory demyelinating polyneuropathy (CIDP) is expected in 2028. Conversely, Immunovant indicated that it may discontinue further development of the drug for Sjögren's syndrome (SjD) following the current Phase 2 trial, citing market conditions and the competitive landscape.
IMVT-1402 is a next-generation FcRn inhibitor for autoimmune diseases, with core technology developed by HanAll Biopharma. Immunovant, which holds the license for the U.S. and European markets, is leading the global clinical trials. The drug works by reducing pathogenic IgG antibodies to mitigate autoimmune responses and is being developed as a subcutaneous injection using an autoinjector.
