• New intranasal formulation with significantly improved stability was well-tolerated and led to local activation of innate immune pathways in adults aged >60
• U.S. Department of Defense (DOD) funded study extension into younger adults aged 18 – 45 will complete dosing in January

MELBOURNE, Australia, Jan. 22, 2025 (GLOBE NEWSWIRE) -- ENA Respiratory, a clinical-stage pharmaceutical company developing antiviral host defense immune enhancers to minimize the impact of viral respiratory infections in at-risk populations, announces today that it has successfully completed dosing of the older adult cohorts in its Phase Ib study of a dry powder formulation of INNA-051. Intranasal administration of the novel and more stable formulation of INNA-051 was well-tolerated and led to local activation of innate immune pathways gene expression.

The study was designed to test the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 administered intra-nasally as a dry powder formulation, which has an anticipated shelf life of over two years at room temperature.

Thirty-two participants aged 60 or over were enrolled in the study. Participants included in the multiple ascending dose cohorts were dosed weekly on three occasions, with a maximum dose of 900 mcg (a 3-fold increase in the maximum dose included in the previous trial with the liquid formulation). Treatment at all doses was well-tolerated, with mainly mild, short duration drug-related AEs limited to the upper respiratory tract. The tolerability observed at these higher doses is similar to the profile observed in previous trials with the liquid nasal spray formulation. Biomarker analysis of nasal samples confirmed that treatment leads to a significant local activation of the innate immune pathways, including antiviral host defense pathways, consistent with previous observations in the clinic.

The DOD-funded extension to assess safety, tolerability and pharmacodynamics of the new formulation in younger adults aged 18-45 is ongoing and will complete dosing later in January. The first cohort dosed with 300 mcg demonstrated that the new formulation safety and tolerability profile is consistent with observations in the older adults. Complete reporting of the study is expected in Q2 2025.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “These results provide an excellent foundation for our planned Phase II Proof of Concept community infection study and reinforce INNA-051’s potential as a convenient, commercially attractive, seasonally-delivered product that minimizes the impact of common viral respiratory infections and prevents serious complications.

“Increased age is the biggest risk factor for morbidity and mortality from such infections and, in the US alone, there are 34.3 million adults aged 60 and over with comorbidities that put them at risk for viral respiratory infections. We have demonstrated that our extended shelf-life formulation of INNA-051 is well-tolerated in this population and triggers an immune response that we believe could be protective and prevent serious disease.”

ENA is currently planning Q4 2025 Phase II community infection study to assess the safety and potential efficacy of INNA-051 in reducing the incidence and duration of symptomatic infections caused by common respiratory viruses, including coronaviruses, seasonal influenza, rhinoviruses, respiratory syncytial virus and human metapneumovirus in young adults at risk for exposure living in the US.

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling respiratory viral infections through the development of host defense immune enhancers which locally prime and boost the body’s innate immune response – the natural first line of defence against invading pathogens. Being virus-agnostic, ENA’s antiviral host defense enhancers offer solutions to protect against common and emerging respiratory viruses for which vaccines or direct-acting antivirals have limitations or do not exist.

The company’s lead product, INNA-051, is being developed as a convenient, once-a-week nasal dry powder product to reduce the impact of viral respiratory infections and prevent severe complications in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel).

INNA-051 is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and potentiating innate immune responses. With a safety profile supporting seasonal prophylaxis use, it has demonstrated accelerated virus clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using a human influenza-challenge model.

Headquartered in Melbourne, Australia, the company has raised US$26M (AU$44million) in equity financing from Brandon Capital, The Minderoo Foundation and Uniseed. It is partnered with the US COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$13.1 million contract from the U.S. Department of Defense. It is an alumni member of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate novel potential solutions for future pandemics.

For more information, please visit https://enarespiratory.com

Follow us on LinkedIn: https://www.linkedin.com/company/enarespiratory-pty-ltd/

For further information, please contact:

Media – Australia

Kirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228

Media – International

Charles Consultants

Sue Charles, E: sue.charles@charles-consultants.com M: +44 (0)7968 726585

Chris Gardner, E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077