ENA Respiratory has announced that researchers at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health will conduct a Phase 2 study of ENA’s INNA-051 intranasal dry powder TLR2/6 agonist, which the company is developing for the treatment of viral respiratory infections. Earlier this year, the company announced that it had received a $5 million investment from Flu Lab to support a Phase 2 proof of concept study of the nasal powder.
UM School of Medicine professor Justin Ortiz will lead the study, which will evaluate the ability of once-weekly dosing of INNA-051 to prevent symptoms caused by viral infections of the respiratory system, with top-line data expected in the third quarter of 2026. The study will enroll healthy adults who are at increased risk of viral respiratory disease and will take place during the winter of 2025 / 2026.
In addition to Flu Lab, ENA Respiratory has received funding from the US Department of Defense and from the COPD Foundation for development of INNA-051. The company initially developed the nasal spay as a liquid formulation, and previously conducted a Phase 2 flu challenge study using that formulation. ENA initiated a Phase 1b trial of the dry powder formulation in August 2024.
ENA Respiratory CEO Christophe Demaison commented, “Partnering with CVD and having Professor Justin Ortiz as one of the principal investigators for this Phase 2 trial is a significant step for ENA Respiratory. The esteemed team at the University of Maryland School of Medicine . . . brings extensive experience and a proven track record in conducting similar trials. We now look forward to working together to deliver the next step in the development of what we believe could be a significant new approach to reducing the enormous burden of respiratory viral diseases.”
Ortiz said, “Viral respiratory infections are a major global public health problem and there is a clear need for new approaches to tackle the complications that lead to significant morbidity and mortality. We are excited to be partnering with ENA Respiratory on this important study to test their new approach for boosting the body’s natural host defense pathways.”
Read the ENA Respiratory press release
