#China #Chengdu #Keymed Biosciences #Stapokibart #IL-4Rα Antibody

Keymed Biosciences Reports Significant Findings on Stapokibart

Keymed Biosciences Inc. recently revealed that the esteemed medical journal, Nature Medicine, has published findings from their Phase-III study on Stapokibart, a unique IL-4Rα antibody designed for the treatment of moderate to severe seasonal allergic rhinitis (SAR). This research, helmed by Professor Luo Zhang from Tongren Hospital in Beijing, marks the first clinical report on an IL-4Rα-targeting biologic for SAR globally. Such progress underscores the pivotal role of Chinese scientists in innovating solutions for allergic rhinitis.

Major Findings from the Study

The trial demonstrated that Stapokibart significantly alleviates the clinical symptoms of patients suffering from moderate to severe SAR, providing relief to those who have not achieved satisfactory control with standard treatments. This advancement introduces a revolutionary remedy to a widespread health issue, promising new hope for millions of patients worldwide.

Rapid Control of Nasal Symptoms

In the trial, patients receiving Stapokibart experienced substantial relief from nasal obstruction. By Day 2, participants showed notable improvements in these symptoms compared to the placebo group. By Day 7, 72% of the Stapokibart group reported unobstructed nasal breathing, with cumulative response rates rising to 86% by Week 2 and 94% by Week 4.

The study also recorded a significant reduction in the daily reflective total nasal symptom score (rTNSS), reflecting a decrease of 2.7 points from baseline by Day 4, which was considerably higher than that observed in the placebo group.

Over a two-week treatment period, the Stapokibart group achieved a 3.6-point decline in daily rTNSS and a statistically significant mean difference compared to placebo. Notably, 62% of patients experienced only mild symptoms or symptom-free status (rTNSS ≤1 for each symptom). Throughout the four-week period, the Stapokibart group observed a 4.9-point reduction in daily rTNSS, with 84% reporting mild or no nasal symptoms.

Improvement in Ocular Symptoms

In addition to nasal symptoms, Stapokibart also demonstrated a clinically meaningful reduction in the total reflective ocular symptom score (rTOSS), showing an improvement of 2.6 points by Week 2 and 3.7 points by Week 4, both significantly higher than those in the placebo cohort. In Week 2, 62% of the participants had mild or no ocular symptoms, which increased to an impressive 94% by Week 4.

Reduction of Type-2 Inflammatory Biomarkers

Over the four-week study duration, Stapokibart was found to significantly lower total serum IgE levels and allergen-specific IgE values against pollen allergens. The treatment also reduced concentrations of biomarkers indicative of Type-2 inflammation in nasal secretions, like Cystatin SN (CST1) and Eotaxin-3, showcasing its dual mechanism of action that targets both the underlying etiology (Type-2 inflammation) and the symptomatic manifestations of allergic rhinitis.

Safety Profile of Stapokibart

Remarkably, Stapokibart exhibited a commendable safety profile among participants with seasonal allergic rhinitis. The incidence of treatment-emergent adverse events (TEAEs) was aligned with that of the placebo, and no severe adverse events (SAEs) were recorded throughout the study.

The PHECDA study paved the way for targeted biologic therapy in treating allergic rhinitis. The promising outcomes prompted the approval of Stapokibart— the world’s first and only monoclonal IL-4Rα antibody for SAR treatment—by China’s National Medical Products Administration (NMPA) on February 7, 2025. This landmark advancement introduces a novel therapeutic option for patients experiencing moderate to severe refractory SAR, reinforcing the leading role of Chinese clinical researchers in allergic rhinitis studies and setting a precedent for future clinical development.