(Press-News.org) Last year, at least one million people in the U.S. were hospitalized for respiratory virus illnesses like the flu or COVID-19, according to the Centers for Disease Control and Prevention. Many of these individuals were at higher risk of getting infections due to living or working around young children who contract more respiratory infections. A new clinical trial led by researchers at the University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health (CVD) will test a new experimental intranasal spray designed to boost immune defenses and reduce illness from respiratory viruses.
The study is being conducted in collaboration with ENA Respiratory, the manufacturer of the novel therapy. The randomized double-blind Phase 2 trial aims to enroll 1,100 healthy adults ages 18 to 45 years who are at increased risk of upper respiratory virus infections due to exposure to young children or frequent close contact with others. Participants will be randomly assigned to receive the intranasal spray, called INNA-051, or a placebo spray to determine if INNA-051 is safe and works better than the placebo at boosting the immune response and preventing illness.
“This study represents a new approach to reducing illness from respiratory infections,” said Justin Ortiz, MD, Professor of Medicine and a respiratory illness specialist who is the UMSOM Principal Investigator for the ongoing trial. “Instead of targeting a single virus, INNA-051 strengthens the body’s early immune defenses, which may help mitigate disease caused by multiple respiratory pathogens.”
A non-vaccine, intranasal spray, INNA-051 works as a prophylactic drug designed to be taken weekly during cold and flu season. It is a TLR2/6 agonist, which works by priming the immune system’s first line of defense in an effort to accelerate the clearance of harmful germs from nasal passages before viruses can get a foothold in the body and cause an infection. INNA-051 is virus-agnostic, meaning that it can potentially help protect against a wide array of viruses, and acts in the nasal passages, the site of initial replication of common respiratory viruses, such as the flu, colds, and COVID-19. The study will investigate whether INNA-051 can reduce the severity or likelihood of illness during respiratory virus season.
“This trial exemplifies CVD’s commitment to conducting innovative clinical research aimed at reducing the burden of infectious disease. INNA-051 has the potential to protect those most vulnerable to respiratory viral complications, including persons with chronic lung disease, heart disease, and diabetes,” said James Campbell, MD, MS, Professor of Pediatrics at UMSOM and Interim Director of the Center for Vaccine Development and Global Health.
UMSOM Dean Mark T. Gladwin, MD, added: “Our researchers are aiming to demonstrate the exciting potential of TLR2/6 agonists to become the first prophylactic therapy against respiratory viral illness. Respiratory viruses continue to challenge our healthcare systems because they evade our body’s most fundamental immune barrier—the mucosal surfaces of our airways. A preventive approach that strengthens this frontline of defense has the potential to transform how we reduce viral transmission in the community and could help build resilience against future respiratory threats.”
To learn more about this and other CVD clinical trials, visit CVDTrials.org.
About the Center for Vaccine Development and Global Health
Founded in 1974, the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health is internationally recognized for its research in vaccine development, infectious disease, and clinical trials that have paved the way for lifesaving interventions around the world. The CVD’s mission is to reduce the global burden of infectious diseases through research, training, and public health impact.
About ENA Respiratory
ENA Respiratory is a clinical-stage pharmaceutical company tackling respiratory viral infections through the development of host defence enhancers which locally prime and boost the body’s natural first line of defence against invading pathogens. Being virus-agnostic, ENA’s approach offers a solution to protect against common and emerging respiratory viruses for which vaccines or direct-acting antivirals have limitations or do not exist.
The company’s lead product, INNA-051, is being developed as a convenient, once-a-week nasal dry powder product to reduce the impact of viral respiratory infections and prevent severe complications in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel). Headquartered in Melbourne, Australia, with operations in the USA, ENA’s Investors include Brandon Capital, Flu Lab, the Gates Foundation, the Minderoo Foundation, Stoic Venture Capital and Uniseed. The Company is partnered with the US COPD Foundation to support patient-focused clinical development of INNA-051 in COPD and has been awarded contracts from the U.S. Government. It is an alumni member of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate novel potential solutions for future pandemics. For more information, please visit https://enarespiratory.com
About the University of Maryland School of Medicine
The University of Maryland School of Medicine, established in 1807 as the first public medical school in the U.S., continues today as one of the fastest growing, top-tier biomedical research enterprises in the world. The School has nearly $500 million total research funding, 46 departments, centers, and institutes, more than 2,200 student trainees and over 3,000 faculty members, including notable members of the National Academy of Medicine. As the largest public medical school in the DC/MD/VA region, faculty-physicians are working to help patients manage chronic diseases like obesity, cancer, heart disease and addiction, while also working on cutting-edge research to address the most critical generational health challenges. In 2024, the School ranked #12 among public medical schools and #27 among all medical schools for R&D expenditures by the National Science Foundation. With a $1.3 billion total operating budget, the School partners with the University of Maryland Medical Center to serve nearly 2 million patients annually. The School's global reach extends around the world with research and treatment facilities in 33 countries. In Maryland, the School of Medicine is spearheading new initiatives in AI and health computing and partnering with the University of Maryland BioPark to develop new medical technologies and bioengineering ventures. For more information, visit medschool.umaryland.edu.
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UM School of Medicine launches clinical trial of investigative nasal spray medicine to prevent illnesses from respiratory viruses
2026-02-02
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