Keymed Biosciences' IL-4Rα Antibody Stapokibart Shows Promising Results in Phase III Trial for Seasonal Allergic Rhinitis

07 April 2025 | Monday | News

Published in Nature Medicine, the breakthrough study demonstrates stapokibart’s potential to significantly improve symptoms and quality of life for patients with moderate-to-severe SAR, paving the way for new biologic treatments in allergic rhinitis.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Keymed Biosciences Inc. announced that the prestigious medical journal Nature Medicine has published the results from the Phase III trial of its independently developed IL-4Rα antibody stapokibart, for the treatment of moderate-to-severe seasonal allergic rhinitis (SAR). The study, led by Professor Luo Zhang of Beijing Tongren Hospital, Capital Medical University, represents the world's first clinical report on an IL-4Rα-targeted biologic for SAR, underscoring Chinese scientists' pioneering role in allergic rhinitis innovation.

The study demonstrated that stapokibart significantly alleviates clinical symptoms and improves quality of life in patients with moderate-to-severe SAR who remained inadequately controlled despite standard therapies. This breakthrough offers a transformative solution to a global health challenge, ushering in a new era of biologic treatments for allergic rhinitis and providing hope to hundreds of millions of patients worldwide. 

Allergic rhinitis (AR), a chronic inflammatory disease of the nasal mucosa, is triggered by environmental allergens in sensitized individuals. In recent years, its global prevalence has risen significantly. Despite standard therapies, over 50% of patients continue to experience inadequately controlled symptoms, a substantial unmet need that severely impacts quality of life and imposes a heavy socioeconomic burden, positioning AR as a critical public health challenge.

The persistence and exacerbation of AR symptoms are primarily driven by amplified type 2 inflammatory cascades. Stapokibart, targeting the IL-4 receptor alpha subunit (IL-4Rα), dual-blocks both IL-4 and IL-13 signaling pathways. Through a multi-pronged approach—inhibiting T-cell activation and proliferation, suppressing B-cell activation and IgE synthesis, and reducing inflammatory cell infiltration—Stapokibart comprehensively attenuates allergic reactions, providing a novel therapeutic strategy for seasonal allergic rhinitis, and other type 2-mediated allergic diseases.

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