Key Takeaways
- ENA Respiratory has successfully completed Phase Ib dosing of its INNA-051 dry powder formulation in older adults aged 60+, demonstrating safety and local immune activation.
- The U.S. Department of Defense (DOD) is funding an extension of the study to evaluate younger adults aged 18-45, with dosing expected to finish in January 2025.
- The results support a planned Phase II trial in Q4 2025, assessing INNA-051’s effectiveness in preventing viral respiratory infections.
ENA Respiratory, a clinical-stage pharmaceutical company developing immune-enhancing antiviral therapies, has announced the successful completion of Phase Ib dosing for its INNA-051 dry powder formulation in older adults. The novel intranasal therapy, designed to boost the body’s innate immune defense, showed a strong safety profile and activated key antiviral immune pathways, reinforcing its potential as a preventative treatment against common respiratory infections.
This dry powder formulation of INNA-051 represents a significant advancement, as it offers improved stability with a two-year shelf life at room temperature, making it a convenient and commercially viable option for at-risk populations. The study, which enrolled 32 participants aged 60 and above, demonstrated that INNA-051 was well-tolerated even at doses three times higher than previous liquid formulations, with only mild, short-duration side effects affecting the upper respiratory tract. Importantly, biomarker analysis confirmed the drug’s ability to activate antiviral host defense pathways, reinforcing its mechanism of action as a broad-spectrum immune booster.
Expanding Research to Younger Adults and Future Phase II Studies
The U.S. Department of Defense (DOD) has funded an extension of the study to evaluate the safety and pharmacodynamics of the dry powder formulation in younger adults (18-45 years old). Initial dosing in this cohort has shown similar tolerability to older adults, with final dosing expected to conclude by the end of January 2025. A full analysis of study results is scheduled for Q2 2025, setting the stage for further clinical development.
Looking ahead, ENA Respiratory is planning a Phase II community infection study in Q4 2025, which will assess INNA-051’s effectiveness in reducing the incidence and severity of respiratory infections. The trial will focus on young adults in high-exposure environments, evaluating the drug’s protective effects against coronaviruses, influenza, rhinoviruses, respiratory syncytial virus (RSV), and human metapneumovirus. Given the high-risk nature of viral respiratory infections in older adults and individuals with comorbidities, INNA-051 has the potential to be a widely accessible, once-a-week intranasal therapy to prevent serious complications from viral infections.
A New Era for Preventative Respiratory Medicine
ENA Respiratory’s antiviral approach is virus-agnostic, meaning it is designed to enhance immunity against multiple respiratory viruses, unlike traditional virus-specific vaccines. The company’s lead product, INNA-051, is a toll-like receptor 2/6 (TLR2/6) agonist, which triggers early immune responses to help the body fight infections before symptoms appear. Previous clinical studies in influenza have already demonstrated accelerated virus clearance, suggesting that INNA-051 could serve as a critical tool in pandemic preparedness and respiratory disease prevention.
With funding support from Brandon Capital, The Minderoo Foundation, and Uniseed, and a $13.1 million contract from the U.S. Department of Defense, ENA Respiratory is well-positioned to accelerate clinical development and commercialize its intranasal therapy for high-risk populations. As the company progresses toward larger-scale studies, INNA-051 could become a game-changing intervention for respiratory health, providing seasonal protection against multiple viral threats.
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