ENA Respiratory secures two US patents for TLR2 agonist COPD programme
ENA Respiratory has received Notices of Allowance from the US Patent and Trademark Office for two patent applications covering its toll-like receptor 2 (TLR2) agonist platform. The grants add a composition-of-matter patent (US 17/622,451) covering a series of TLR2 agonist compounds and a method-of-use patent (US 16/495,829) directed at treating rhinovirus-mediated exacerbations of chronic obstructive pulmonary disease. The Melbourne-headquartered company said the allowances extend potential exclusivity for its lead candidate, INNA-051, to at least 2042.
The two new allowances bring ENA Respiratory's total intellectual property estate to 55 granted patents and allowed applications across the United States, Europe, the United Kingdom, Japan and China, spread across seven distinct patent families. A further 39 applications remain pending in various jurisdictions, the company said, describing the portfolio as part of a "comprehensive lifecycle management strategy."
The clinical case for rhinovirus prevention
The rationale for rhinovirus-specific protection in COPD patients is well established in the academic literature. Respiratory viral infections are associated with up to 64% of acute exacerbation events, with rhinovirus accounting for the majority of virus-positive cases. In the United States alone, COPD is linked to approximately 854,000 emergency department visits, more than 335,000 hospitalisations and around 142,000 deaths annually, according to CDC data. Despite rhinovirus being the most commonly identified viral trigger of acute exacerbations, no licensed vaccine or antiviral against the pathogen currently exists, leaving a significant clinical gap.
Christophe Demaison, CEO of ENA Respiratory, said the allowances "reinforce our confidence in the future global commercial value of INNA-051 as we advance through clinical development," noting that the composition-of-matter patent protects the TLR2 agonist platform broadly while the method-of-use patent secures targeted protection for the COPD prevention indication.
Phase II progress and competitive landscape
ENA Respiratory's ongoing Phase II POSITS study (NCT07222670) is evaluating INNA-051 as a once-weekly dry powder nasal spray over up to three months in young adults at heightened risk of respiratory infection through crowded living or working conditions. The study is assessing the incidence, duration and severity of symptomatic infections caused by influenza, RSV, rhinovirus and coronaviruses.
The virus-agnostic mechanism of INNA-051 distinguishes it from pathogen-specific vaccines and antivirals. By locally priming innate immune responses via TLR2/6 rather than targeting a single virus's surface proteins, the approach is designed to retain efficacy against antigenically drifted or novel strains. The company has previously reported accelerated virus clearance in a Phase IIa human influenza-challenge model.
The innate immune modulation space for respiratory infection prevention remains relatively uncrowded at the clinical stage, though broad-spectrum antiviral approaches have attracted renewed interest following the COVID-19 pandemic. ENA Respiratory's backer list, which includes the Gates Foundation, the Minderoo Foundation and US Government contracts, alongside its BARDA-linked BLUE KNIGHT alumnus status, gives it a degree of non-dilutive funding insulation that many clinical-stage peers lack. The POSITS readout will be closely watched as the first community-based efficacy signal for INNA-051 beyond controlled human-challenge conditions.