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

Keymed Biosciences Announces Groundbreaking Findings in Seasonal Allergic Rhinitis Treatment

In a significant achievement for allergy treatment, Keymed Biosciences Inc. has announced that prestigious journal, Nature Medicine, has published the results from the Phase III study of Stapokibart, an anti-IL-4Rα monoclonal antibody developed independently. This landmark research is authored by Professor Luo Zhang from the Capital Medical University’s Tongren Hospital, marking the first clinical report globally on a biological product targeting IL-4Rα for moderate to severe seasonal allergic rhinitis (SAR).

The study reveals that Stapokibart provides substantial relief from clinical symptoms and greatly enhances the quality of life for SAR patients, particularly those inadequately controlled by standard therapies. This new treatment option emerges as a transformative solution to a widespread health issue, signifying a pivotal turn in biological treatments for allergic rhinitis, while offering hope to millions of afflicted individuals worldwide.

Quick and Sustained Control Over Nasal Symptoms

Key findings from the clinical trial indicate that patients administered Stapokibart experienced a quick alleviation of nasal congestion compared to the placebo group. Remarkably, 72% of patients reported clear nasal breathing by the second day. By week two, the cumulative response rate climbed to 86%, reaching 94% by week four.

Moreover, Stapokibart displayed a reduction of 2.7 points in reflective daily total nasal symptom scores (rTNSS) by day four, significantly outperforming placebo improvements. Over the two-week treatment period, the stapokibart cohort showed a reduction of 3.6 points in daily rTNSS compared to baseline, with a mean difference of -1.3 points against placebo. Ultimately, 62% of those given Stapokibart reported mild or no symptoms (defined as rTNSS ≤1 point per symptom).

After four weeks of treatment, the Stapokibart group exhibited a remarkable reduction of 4.9 points in daily rTNSS from baseline, with a mean difference of -1.7 points from placebo. An impressive 84% of patients experienced mild or no nasal symptoms by the end of the study.

Significant Improvement in Eye Symptoms

The study further demonstrated that Stapokibart resulted in clinically significant improvements in the daily reflective total ocular symptom scores (rTOSS). By week two, patients noted a 2.6-point enhancement, increasing to 3.7 points by week four, both markedly surpassing placebo effects. By week two, 62% of participants reported mild or absent ocular symptoms (rTOSS ≤1 point), escalating to 94% by week four.

Notable Reduction of Type 2 Inflammatory Biomarkers

Throughout the four-week treatment, Stapokibart led to significant reductions in both total serum IgE and allergen-specific IgE levels against pollen allergens. Its dual mechanism of action effectively targets both the underlying Type 2 inflammation and the symptomatic manifestations of allergic rhinitis. Markedly, it decreased levels of Type 2 inflammatory biomarkers in nasal secretions, such as cystatin SN (CST1) and eotaxin-3.

Safety Profile

In terms of safety, Stapokibart exhibited a favorable profile among SAR patients. The incidence of treatment-related adverse events was comparable to that of the placebo group, with no serious adverse events reported during the trial.

The PHECDA trial is trailblazing for targeted biological therapies addressing allergic rhinitis. Results have encouraged approval for Stapokibart as the first and only IL-4Rα monoclonal antibody for seasonal allergic rhinitis by the National Medical Products Administration of China (NMPA) on February 7, 2025. This breakthrough offers a novel therapeutic avenue for patients battling moderate to severe refractory SAR, further establishing the leading role of Chinese clinical scientists in allergic rhinitis research and setting the stage for future clinical innovations.