New Long-Term Data Shows Promising Results for Stapokibart in Treating Severe Atopic Dermatitis

Introduction to the Study

Keymed Biosciences Inc. recently presented new long-term efficacy and safety data from a Phase-III clinical trial of Stapokibart at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. The study focused on patients with moderate to severe atopic dermatitis, a chronic skin condition characterized by inflammation and itching.

The trial emphasized the sustained effectiveness and favorable safety profile of Stapokibart over an extended treatment period. No new safety concerns were identified, augmenting the potential for this medication as a reliable option for patients.

Study Design

This Phase-III clinical trial was designed as a multicenter, randomized, double-blind, and placebo-controlled study. A key goal was to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in adult patients with moderate to severe atopic dermatitis.

The study enrolled 476 participants who were randomly assigned to either the Stapokibart treatment group or the placebo group. Over 52 weeks, the patients received either Stapokibart or a placebo to assess the long-term effects of the medication.

Main Findings

At the 52-week mark, an impressive 92.5% of patients continuing on Stapokibart achieved an EASI-75 (a 75% improvement in the Eczema Area and Severity Index). Similarly, those who switched from placebo to Stapokibart saw improvements, with 88.7% reaching the EASI-75 milestone.

Furthermore, 67.3% of patients in the continued Stapokibart group achieved an Investigator's Global Assessment (IGA) score of 0/1 with a reduction of ≥2 points. These figures were closely matched by the 64.2% in the transfer group, indicating robust efficacy.

Impact on Quality of Life

The long-term use of Stapokibart not only improved the clinical symptoms of atopic dermatitis but also significantly enhanced patients' quality of life. Participants reported better daily functioning and a noticeable reduction in itching, which is often the most distressing symptom.

During the maintenance phase, only 0.9% of patients experienced a relapse, highlighting the medication's potential for maintaining stable condition over long periods.

Safety Profile

When it comes to safety, Stapokibart was well-tolerated among the participants. The safety data over the 52-week period aligned with those observed in the initial 16-week double-blind study. Importantly, no new safety signals were detected, reinforcing the medication's reliability.

Details on Stapokibart

Stapokibart, also known as CM310, is a potent humanized antibody that targets the interleukin-4 receptor alpha subunit (IL-4Rα). It is the first domestically produced IL-4Rα antibody medication approved for clinical trials in China by the National Medical Products Administration (NMPA).

By targeting IL-4Rα, Stapokibart effectively blocks the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), two crucial cytokines involved in type 2 inflammation. Previous studies have shown promising results regarding the safety and effectiveness of Stapokibart.

Approval Status

The application for new drug approval for Stapokibart as a treatment for moderate to severe atopic dermatitis in adults has been accepted by the NMPA. The drug was given priority review status in December 2023, reflecting its potential impact and need in clinical practice.

About Keymed Biosciences Inc.

Keymed Biosciences Inc. is dedicated to addressing unmet clinical needs by providing high-quality, affordable, and innovative therapies both in China and internationally. The company operates a fully integrated platform encompassing all critical functions from target validation and molecule discovery to clinical development and manufacturing.

This integrated approach has enabled Keymed to quickly and efficiently advance a diverse pipeline of antibody-based therapies, including monoclonal antibodies, antibody-drug conjugates (ADCs), and bispecific antibodies.