#China #Chengdu #Stapokibart #Allergic Rhinitis #Keymed

Major Breakthrough in Allergy Treatment: Phase III Trial Results of Stapokibart

In a significant advancement for the medical community, Keymed Biosciences Inc. has announced the publication of Phase III trial results for their innovative treatment, Stapokibart, which targets seasonal allergic rhinitis (SAR). The study was reported in the esteemed journal, Nature Medicine, marking a pivotal moment for allergy therapy and highlighting the contributions of Chinese scientists in this field.

The Impact of Stapokibart on Seasonal Allergic Rhinitis

Led by Professor Luo Zhang from Beijing Tongren Hospital, this groundbreaking research presents the first clinical findings on an IL-4Rα-targeted biologic for SAR. The results indicate that Stapokibart significantly alleviates the symptoms associated with moderate-to-severe SAR, demonstrating particularly promising results for patients who have not responded well to standard treatment regimens.

Patients treated with Stapokibart showed rapid improvements in nasal congestion, with many achieving clearer nasal breathing by Day 7. The data showed that 72% of participants noted relief after initiating treatment, which increased to 94% by the end of four weeks. This rapid onset of action, alongside a substantial reduction in daily reflective total nasal symptom scores (rTNSS), suggests that Stapokibart represents a transformational option in allergy treatment.

Ocular Symptom Relief

Notably, the trial also highlighted Stapokibart’s efficacy in reducing ocular symptoms associated with allergies. The average decrease in the daily reflective Total Ocular Symptom Score (rTOSS) was significantly greater compared to the placebo group, showcasing the product’s dual mechanism of action. By Week 4, 94% of participants reported experiencing mild or no ocular symptoms, further underpinning Stapokibart's potential as a comprehensive treatment option for allergy sufferers.

Targeting Type 2 Inflammation

Furthermore, the study evaluated how Stapokibart acted against type 2 inflammatory biomarkers, a common pathway for allergic reactions. Results indicated that the treatment effectively lowered levels of total serum IgE and specific IgE against pollen, along with biomarkers like cystatin SN (CST1) and eotaxin-3. This highlights the treatment’s innovative mechanism in addressing both the root cause of allergies and their symptomatic effects.

Safety Profile

In terms of safety, the trial demonstrated that Stapokibart possesses a favorable profile, with no reports of serious adverse events. The side effects experienced by participants in the Stapokibart group were comparable to those in the placebo group, affirming the drug’s viability for public use.

Conclusion and Future Implications

This clinical trial represents a significant milestone in the realm of allergic rhinitis treatment, as it supports the recent approval of Stapokibart by the National Medical Products Administration (NMPA) in China. As the world’s first IL-4Rα monoclonal antibody for SAR, Stapokibart not only provides a unique therapeutic avenue for patients suffering from moderate-to-severe allergic rhinitis, but it also seals China's position as a leader in clinical allergy research. The prospects of further advancements in biologic therapies for SAR hold promising potential for millions affected globally, as Keymed's efforts continue to shape the future of allergy management.