ENA Respiratory is partnering with the University of Maryland’s Center for Vaccine and Global Development (CVDGH) to conduct a Phase 2 clinical trial of INNA-051. The study, led by Dr. Justin Ortiz, will evaluate the safety, tolerability, and efficacy of the nasal powder in preventing viral respiratory infections in at-risk adults. The trial is expected to yield results in Q3 2026.
This collaboration is important because it leverages CVDGH’s expertise in respiratory virus research and provides a platform for rigorously testing INNA-051’s potential in a real-world setting. A successful trial could significantly impact public health by offering a new preventative measure against a range of respiratory viruses, particularly for vulnerable populations. This prophylactic approach contrasts with the limitations of vaccines and antiviral medications, which are often virus-specific and may not address emerging threats.
The Phase 2 trial will be a randomized, double-blind, placebo-controlled, multicenter study conducted during the 2025/26 North American fall/winter season. INNA-051, a TLR2/6 agonist delivered weekly as a nasal powder, aims to enhance the body’s natural antiviral defenses. This approach may offer broader protection compared to traditional methods. Previous studies have shown promising results with INNA-051 demonstrating accelerated viral clearance and stimulation of antiviral responses.
A positive outcome from this Phase 2 trial would be a significant advancement for ENA Respiratory and could pave the way for broader clinical development and potential regulatory approval. It could also represent a novel strategy for managing respiratory infections, offering a valuable tool alongside existing preventative measures like vaccination. The development of a broadly effective prophylactic treatment could significantly reduce the burden of respiratory illnesses, particularly for high-risk individuals, and may also prove valuable in mitigating the impact of future pandemics.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
