ENA Respiratory Announces Extension of U.S. Department of Defense Funding for Novel Prophylactic Antiviral

• New US $3.13 million DOD contract extension to fund inclusion of younger adults in the ongoing Phase Ib study of INNA-051 nasal dry powder formulation and drug product optimization activities

Melbourne, Australia, 5 September 2024 – ENA Respiratory, a clinical-stage pharmaceutical company developing innate immune modulators for the prevention of complications associated with respiratory viral infections in at-risk populations, has been awarded an additional US $3.18 million contract from the U.S. Department of Defense (DOD).

The new funding extends the US $8.18 million already committed by the DOD to support the development of INNA-051. It will be used to expand ENA’s Phase Ib study of its dry powder formulation of INNA-051 to younger adults and support product optimization ahead of Phase IIb initiation.

The IND opening Phase Ib study in adults over the age of 60 was initiated in Q2 2024. A DOD-funded protocol amendment will support inclusion of individuals aged 18-45 with the aim of informing dose selection for subsequent trials. Results from the study are expected in the Q4 2024.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “This new funding from the DOD is further recognition of the potential of INNA-051 to play a significant role in protecting individuals at risk of serious harm from respiratory viral infections, including those with occupational risk. We are grateful to the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense for its continued support.”

The contract was awarded by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), in collaboration with the Defense Innovation Unit (DIU). Reference to the DOD, JPEO-CBRND, or other agency of the United States does not constitute or imply an endorsement or recommendation by the U.S. government or any agency thereof.

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling serious respiratory viral infections through the development of host defence immune modulators which locally prime and boost the body’s innate immune response – the natural first line of defence. Being virus-agnostic, immune modulators are complementary to often virus-specific vaccines and existing direct-acting antivirals.

The company’s lead product, INNA-051, is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and triggering the innate immune response. With a safe profile supporting 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.

INNA-051 is being developed as a convenient, once-a-week nasal dry powder product to prevent complications associated with respiratory viral infections 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).

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$11.3 million contract from the U.S. Department of Defence. It is a 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