ENA Respiratory Advances Phase Ib Trial of Dry Powder INNA-051

ENA Respiratory, a clinical-stage pharmaceutical company based in Melbourne, Australia, has announced progress in its Phase Ib study of the dry powder formulation of its drug, INNA-051. This new formulation is designed to enhance stability, boasting a shelf life of over two years at room temperature. The study evaluates the safety, tolerability, and pharmacological properties of INNA-051 when administered intranasally to individuals aged 60 and above. Recruitment for the study, conducted at Scientia Clinical Research facility in Sydney, aims to enroll up to 40 participants.

Initial results from the first two cohorts, who received single ascending doses, have met safety expectations. The study has now progressed to the multiple ascending dose phase, where participants receive weekly doses. The outcomes of this phase are expected in the fourth quarter of the year.

Dr. Christophe Demaison, CEO of ENA Respiratory, highlighted the ongoing challenges posed by serious viral respiratory infections, particularly for older adults with underlying health conditions. Despite advancements in vaccines and antiviral treatments, these infections remain a significant cause of hospitalization and mortality, affecting over 34 million people in the US. INNA-051 is engineered to boost the body’s innate immune response directly at the infection site, potentially preventing complications from various respiratory viral infections.

INNA-051 is a first-in-class intranasal antiviral host defence immunomodulator, acting as an agonist of toll-like receptor 2/6 (TLR2/6). This receptor is crucial for recognizing pathogens and initiating the innate immune response. Previous Phase IIa studies using a liquid formulation demonstrated accelerated viral clearance and stimulated local antiviral defences in an influenza challenge model. The new dry powder formulation not only extends shelf life but also eliminates the need for cold-chain storage and distribution.

Looking ahead, ENA Respiratory is preparing for an international Phase IIb study. This study will assess the safety and potential efficacy of INNA-051 in reducing the duration and severity of community-acquired respiratory viral infections among older adults in assisted living facilities. These individuals are at increased risk due to comorbidities, including chronic obstructive pulmonary disease (COPD), asthma, cardiovascular disease, and diabetes.

ENA Respiratory focuses on developing host defence immune modulators to combat severe respiratory viral infections. These modulators prime and boost the body's innate immune response, providing a complementary approach to virus-specific vaccines and direct-acting antivirals. INNA-051, the company's lead product, has shown promise in accelerating viral clearance and enhancing antiviral defences. Intended for prophylactic use, it is being developed as a convenient, once-a-week nasal dry powder to prevent complications in at-risk populations, including the elderly and those with underlying health conditions or occupational risks.

The company, headquartered in Melbourne, has secured US$26 million in equity financing from investors like Brandon Capital, The Minderoo Foundation, and Uniseed. It collaborates with the COPD Foundation to advance INNA-051's clinical development in COPD and has received an $8.18 million contract from the U.S. Department of Defense. ENA Respiratory is also a member of BLUE KNIGHT™, an initiative by Johnson & Johnson Innovation and BARDA to accelerate solutions for future pandemics.

By developing a stable, dry powder formulation of INNA-051 and progressing through clinical trials, ENA Respiratory aims to provide an effective tool in the fight against serious respiratory viral infections, potentially benefiting millions at risk.

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