Rho Announces Findings from Study it Coordinated to Explore Therapy for Reducing Asthma Attacks Among Disadvantaged Urban Youth
August 12, 2022
New NIAID-sponsored trial identifies asthma-associated gene networks affected by mepolizumab antibody
Research Triangle Park, NC – August 2022
Rho, a full-service contract research organization (CRO) with a proven track record of drug development success, today announced findings from a clinical trial it supported as the Statistical and Clinical Coordinating Center for the Inner-City Asthma Consortium (ICAC) to assess the efficacy of a monoclonal antibody for reducing asthma attacks in disadvantaged urban youth. The results of this trial, which was sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), were published today in the journal The Lancet.
The study, called Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 2 (MUPPITS-2), showed that mepolizumab decreased asthma attacks by 27% in Black and Hispanic children and adolescents who have a form of severe asthma, are prone to asthma attacks and live in low-income urban neighborhoods. The study found that combining mepolizumab with guidelines-based care reduced the number of asthma flare-ups compared with guidelines-based care alone during a 52-week period.
“We’re proud to be a part this study which carries important implications for vulnerable populations, including urban Black and Hispanic children who are at the greatest risk of morbidity and mortality from asthma and are often under-represented in clinical trials,” said Dr. Cynthia Visness, principal research scientist, Rho. “The mechanistic analyses in this study allowed us to uncover molecular pathways of this disease that will help facilitate targets for interventional strategies in the future.”
The MUPPITS-2 trial was conducted by the NIAID-funded ICAC as part of a multi-study, multi-center initiative to explore the causes of the urban asthma epidemic that afflicts millions of children and to develop treatments to improve control of asthma for children. The Rho study team helped facilitate research through trial enrollment and protocol development, building the electronic data capture system, data management and sample tracking as well as product safety, clinical monitoring and final statistical analysis.
This study incorporated an innovative exploratory analysis of gene activity, which was conducted by extracting ribonucleic acid (RNA) from the nasal secretions that were sequenced and examined along with those identified during the MUPPITS-1 precursor trial. Investigators found that although mepolizumab significantly tamped down the activity of three networks of genes associated with airway inflammation and asthma attacks, it did not reduce the activity of six other such networks.
“The findings may partially explain why mepolizumab therapy was only modestly successful in reducing asthma exacerbations compared to other studies, especially those in adults,” added Visness. “By identifying how gene networks play a role in asthma attacks within disadvantaged urban children, the MUPPITS-2 trial will help advance the search for new asthma therapies for this population and potentially others.”
The MUPPITS-2 trial was funded by the NIAID and National Center for Advancing Translational Sciences, both part of the NIH, as well as GlaxoSmithKline. ICAC conducted the study under the leadership of Daniel J. Jackson, M.D., William W. Busse, M.D., and Matthew C. Altman, M.D.
The study’s findings are available to download at this link. Additional information about the trial is available at ClinicalTrials.gov under study identifier NCT03292588. To learn more about Rho, please visit www.rhoworld.com.
Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. For more than 36 years, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on Facebook, LinkedIn, Twitter, and Instagram.