#China #Chengdu #Keymed Biosciences #Stapokibart #Nature Medicine

Keymed Biosciences Phase III Study Results Published

In a notable achievement for allergenic treatments, Keymed Biosciences Inc. announced that the esteemed medical journal Nature Medicine has published the results of a Phase III study on stapokibart, an independently developed IL-4Rα antibody targeting moderate to severe seasonal allergic rhinitis (SAR). The study, led by Professor Luo Zhang from the Tongren Hospital of Beijing, Capital Medical University, marks the first global clinical report on a biological product addressing IL-4Rα specifically for rhinitis, underscoring the innovative contributions of Chinese scientists in this medical field.

Significant Clinical Findings

The study revealed that stapokibart significantly alleviates clinical symptoms and enhances the quality of life for patients suffering from insufficient control despite conventional treatments. This discovery opens new avenues for biological therapy in managing seasonal allergies, providing hope to hundreds of millions worldwide.

Rapid and Sustainable Symptom Control

The trial demonstrated that patients receiving stapokibart experienced a marked reduction in nasal congestion symptoms from day two compared to the placebo group. By day seven, 72% of patients reported clear nasal breathing, with cumulative response rates of up to 86% by week two and 94% by week four. Furthermore, stapokibart showed a remarkable daily rTNSS reduction of 2.7 points by day four, significantly outperforming the placebo group.

Over the two-week treatment period, there was an average decline of 3.6 points in daily rTNSS, confirming its effectiveness relative to traditional therapies. In week four, 84% of stapokibart recipients reported mild or no symptoms, highlighting its potential as a transformative treatment.

Significant Improvement in Ocular Symptoms

Beyond nasal relief, stapokibart also provided considerable improvements in ocular symptoms, demonstrated by clinically significant reductions in rTOSS scores. Patients noted an improvement of 2.6 points by week two and 3.7 points by week four, with 62% experiencing mild to no ocular symptoms at week two, increasing to an impressive 94% by week four.

Reductions in Inflammatory Biomarkers

Throughout the four-week treatment phase, stapokibart was shown to lower total IgE levels and specific allergen-related IgE, especially against pollen allergens. Additionally, significant reductions in type 2 inflammatory biomarkers were observed in nasal secretions, which not only highlights stapokibart's efficacy in symptom relief but also its impact on the underlying inflammatory causes of SAR.

Safety Profile

The trial reaffirmed the safety profile of stapokibart, with its adverse event rates comparable to that of the placebo, and no severe adverse effects reported. This excellent safety record strengthens the case for stapokibart's development in clinical settings.

The PHECDA trial has paved the way for targeted biological therapy in allergic rhinitis, with the results substantiating the approval of stapokibart, which the National Medical Products Administration of China granted on February 7, 2025. This groundbreaking development offers a new therapeutic option for patients with moderate to severe refractory SAR, reinforcing China's standing as a leader in clinical research on allergic rhinitis and setting the stage for future advancements in treatment options.