The autoimmune disease drug candidate "IMVT-1402 (IMVT-1402)" under development by HanAll Biopharma showed meaningful therapeutic effects in a global clinical trial for patients with highly refractory rheumatoid arthritis who had not responded to existing treatments.
Immunovant, HanAll Biopharma's global partner, said on the 20th (local time) in its quarterly earnings announcement that it released the week 16 interim analysis results of the IMVT-1402 clinical trial in patients with Difficult-to-treat Rheumatoid Arthritis (D2T RA).
The trial enrolled 170 patients who failed to benefit despite using two or more state-of-the-art targeted therapies with different mechanisms, including first-generation disease-modifying antirheumatic drugs (DMARDs), anti-TNF therapies, and JAK inhibitors. In clinical practice, these patients are classified as a "highly refractory patient group."
According to the released results, the ACR20 response rate at week 16 among patients treated with IMVT-1402 was 72.7%. ACR20 refers to the proportion of patients whose joint pain, swelling, and other symptoms improved by 20% or more.
The ACR50 response rate, indicating symptoms improved by 50% or more, was 54.5%, and the ACR70 response rate, the proportion of patients with symptoms improved by 70% or more, was 35.8%. The company said this is meaningful in that improvement up to severe symptoms was confirmed in a patient group that had not responded to existing therapies.
No new concerns were identified regarding safety. Immunovant said no new safety signals related to the drug were observed in this trial, and overall tolerability was excellent.
IMVT-1402 is a first-in-class FcRn inhibitor that modulates immunoglobulin G (IgG) antibodies in the body. Many patients with rheumatoid arthritis carry autoantibodies such as anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF), and IMVT-1402 works by reducing these pathogenic autoantibodies. This is a different approach from existing anti-TNF therapies or JAK inhibitors that block inflammatory signaling.
However, these results are interim analysis data from a global phase 2–type study and are not yet confirmatory. The currently disclosed findings are the week 16 results of an open-label study in which all patients received the drug, and the company plans to release results from an ongoing placebo-controlled, double-blind follow-up study in the second half of this year.
IMVT-1402 is also in global clinical development for major autoimmune diseases beyond rheumatoid arthritis, including myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjögren's syndrome (SjD), and Graves' disease (GD).
Park Seung-guk, CEO of HanAll Biopharma, said, "We confirmed the potential to become a new treatment option for patients who do not respond to existing advanced therapies such as anti-TNF therapies or JAK inhibitors," adding, "We will develop it into a globally competitive new drug with autoantibody-lowering effects and dosing convenience." HanAll Biopharma is the new drug R&D subsidiary of Daewoong Pharmaceutical.