ENA Respiratory announced that it has completed a Phase 1a study and has initiated a Phase 1b study of its INNA-051 TLR2/6 agonist pan-viral nasal powder in people aged 60 and older. Earlier this year, the company announced that the FDA had cleared an IND for the Phase 1b trial. According to the company, the new trial is expected to enroll up to 40 participants.
Development of the dry powder formulation of INNA-051 was supported by the US Department of Defense. ENA Respiratory says that the new formulation can be stored for more than 24 months at room temperature.
In February 2023, the company announced that a Phase 2a influenza challenge study of the earlier liquid formulation had been complicated by pre-existing immunity of many of the participants to the challenge strain but that, after excluding those participants, the trial demonstrated that INNA-051 shortened the duration of infection. The company now says that it is preparing for a Phase 2b trial of INNA-051 that will enroll residents of assisted living facilities who have comorbidities such as asthma, COPD, and diabetes.
ENA Respiratory CEO Christophe Demaison commented, “Despite advances in vaccines and antiviral treatments, serious viral respiratory infections remain a major cause of hospitalization and mortality for older adults with comorbidities, a population of over 34 million people in the US alone. INNA-051 is designed to boost the body’s innate immune response, the natural first line of defense, directly at the site of infection and prevent complications relating to viral infections whether caused by a common respiratory virus or an emerging new strain. This Phase 1b is a further important step in our clinical development plan as we aim to bring this potentially impactful new approach to patients at risk of significant harm from respiratory viral infections.”
Read the ENA Respiratory press release.
