The ongoing study, conducted at the Scientia Clinical Research facility in Sydney, Australia, is focused on evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 when administered intranasally. The study plans to recruit up to 40 participants, with the goal of providing robust data that will inform further clinical development. The first two cohorts have successfully received single ascending doses, with safety results aligning with expectations based on INNA-051's mode of action. With the successful completion of these initial phases, the study has now progressed to the multiple ascending dose phase, involving weekly dosing. The results from this phase are eagerly anticipated in Q4 of this year.
Christophe Demaison, CEO of ENA Respiratory, emphasized the importance of this research in addressing a critical unmet need.
“Despite significant advancements in vaccines and antiviral treatments, serious viral respiratory infections continue to be a leading cause of hospitalization and mortality among older adults, particularly those with comorbidities. INNA-051 is designed to enhance the body's innate immune response—the natural first line of defense—directly at the site of infection. Our goal is to prevent complications related to viral infections, whether caused by a common respiratory virus or a new emerging strain.”
INNA-051 is a virus-agnostic intranasal antiviral host defense immunomodulator and is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6). This receptor plays a key role in recognizing pathogens and triggering the innate immune response. In a phase 2a proof-of-principle study using a liquid formulation in an influenza-challenge model, INNA-051 demonstrated accelerated viral clearance and stimulated local antiviral host defenses. The new dry powder formulation now being tested extends the product’s shelf life to over 24 months at room temperature, eliminating the need for cold-chain storage and distribution, which is particularly advantageous for global deployment.
Looking ahead, ENA Respiratory is preparing for an international phase 2b study to evaluate the safety and potential efficacy of INNA-051 in reducing the duration and severity of illness associated with community-acquired respiratory viral infections. This study will focus on older adults in assisted living facilities, a group particularly at risk due to comorbidities such as COPD, asthma, cardiovascular disease, and diabetes.
With a safe profile that supports prophylactic use, INNA-051 is positioned to become a crucial tool in the prevention of respiratory complications in at-risk populations. ENA Respiratory’s continued progress highlights the potential of INNA-051 to transform the management of respiratory viral infections, providing a much-needed solution for vulnerable populations worldwide.
