Sanofi and Mount Sinai Complete REGAIN Clinical Study to Predict Response to Asthma Biologic Therapies
Fusion of Real-World Data and Genomics
The REGAIN clinical trial (NCT06623435), a precision medicine study for asthma led by the Icahn School of Medicine at Mount Sinai and jointly conducted by Sanofi (SNY) and GeneDx (WGS), has been completed. This study focuses on combining real-world data (RWD) and genomic data to elucidate the molecular networks of asthma. The study, which involved a large cohort of 1,075 patients, aims to enable gene-based precision diagnostics and personalized prescriptions, thereby addressing unmet needs for individual patients.
Personalized Innovation in the Biologics Market
The market for severe asthma treatments is currently highly competitive, with various biologics such as Sanofi's dupilumab (IL-4Rα target), AstraZeneca's benralizumab, and GSK's mepolizumab. However, there is an urgent need for personalized prescriptions based on individual immune phenotypes due to varying drug responses. The REGAIN study conducted a detailed analysis by establishing five cohorts: a biologic therapy group, a treatment failure group, and a Type 2 inflammation reduction group. This classification maximizes drug administration efficiency, providing commercial benefits that increase the clinical success rates of pharmaceutical companies.
The Value of Multi-Omics Network Analysis
The researchers conducted parallel analysis of nasal brushing RNA transcriptomics and peripheral blood genomics to obtain multi-omics data. They moved beyond conventional single-biomarker approaches and introduced network techniques to analyze gene interactions. This has opened up opportunities to elucidate the pathological mechanisms of asthma and identify key targets for new drug development. This is expected to accelerate the development of Sanofi's next-generation pipeline and enhance GeneDx's genomic diagnostic platform.
Real-Time Monitoring Through Digital Health Integration
The study integrated digital health solutions, including mobile apps and digital inhaler monitors, to track patients' adherence and lung function in real-time. It also utilized geolocation data to comprehensively analyze environmental factors to which patients are exposed. This real-time data collection, combined with genomic information, will establish a new precision medicine standard for proactively preventing acute exacerbations of severe asthma.
The completion of the REGAIN clinical study (NCT06623435) will significantly improve the ability to select targets based on precision medicine in the global asthma biologics market, which exceeds $10 billion annually. In a market where various competing drugs, including Sanofi's (SNY) dupilumab, AstraZeneca's benralizumab, and GSK's mepolizumab, are vying for dominance, a database that connects patients' multi-omics data with clinical responses will become a key asset for increasing the success rate of new drug development. By securing transcriptomic and genomic data from a large cohort of 1,075 actual patients, the development of next-generation immune-targeted therapies that overcome drug resistance mechanisms is expected to be accelerated in the medium to long term. GeneDx (WGS), which is responsible for genomic analysis, has also gained an opportunity to strengthen the clinical reliability of its genomic diagnostic platform and expand its market share in the area of severe respiratory diseases through this joint research.
Source: ClinicalTrials.gov (api_ct)