TLR6

Advances a new formulation with improved stability in the clinicSingle ascending dose phase successfully completed, multiple ascending dose phase underway MELBOURNE, Australia, Aug. 27, 2024 (GLOBE NEWSWIRE) -- 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, announces today that it has advanced its Phase Ib study of its dry powder formulation of INNA-051 to enable clinical progression of an improved drug product with an anticipated shelf life of over two years at room temperature. The study is designed to test the safety, tolerability, pharmacodynamics, and pharmacokinetics of INNA-051 administered intra-nasally as a new dry powder formulation to individuals aged 60 and over. The study is to recruit up to 40 participants and is being conducted at Scientia Clinical Research facility in Sydney, Australia. The first two cohorts have successfully been dosed with single ascending doses with safety in line with expectations for INNA-51’s mode of action and the multiple ascending dose phase of weekly dosing is underway. Results are expected in Q4 of this year. ENA Respiratory’s CEO, Christophe Demaison, PhD, said: “Despite advances in vaccines and antiviral treatments, serious viral respiratory infections remain a major cause of hospitalisation and mortality for older adults with comorbiditiesi, a population of over 34 million people in the US alone. INNA-051 is designed to boost the body’s innate immune response – the natural first line of defence – directly at the site of infection and prevent complications relating to viral infections whether caused by a common respiratory virus or an emerging new strain. This Phase Ib is a further important step in our clinical development plan as we aim to bring this potentially impactful new approach to patients at risk of significant harm from respiratory viral infections.” A virus-agnostic intranasal antiviral host defence immunomodulator, INNA-051, is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6), which plays a key role in recognizing pathogens and triggering the innate immune response. Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences in a Phase IIa proof-of-principle study using a liquid formulation in an influenza-challenge model, ENA Respiratory has developed an improved dry powder formulation which extends product shelf life to more than 24 months at room temperature with no requirement for cold-chain storage and distribution. ENA is preparing for an international Phase IIb study to assess the safety and potential efficacy of INNA-051 in decreasing the duration and severity of illness related to community-acquired respiratory viral infections in older adults in assisted living facilities at risk due to comorbidities including COPD, asthma cardiovascular disease and diabetes. 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 viral clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using an 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 COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$8.18million contract from the U.S. Department of Defence. It is a member BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen 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 – AustraliaKirrily Davis, E: kdavis@bcpvc.com M: +61 (0)401 220228 Media – InternationalCharles ConsultantsSue Charles, E: sue.charles@charles-consultants.com M: +44 (0)7968 726585Chris Gardner, E: Chris@CGComms.onmicrosoft.com M: +44 (0)7956 031077 ____________________ i https://archive-cdc-gov.libproxy1.nus.edu.sg/#/details?url=https://www-cdc-gov.libproxy1.nus.edu.sg/ncird/surveillance/respiratory-illnesses/index.html

MELBOURNE, Australia, April 29, 2024 (GLOBE NEWSWIRE) -- 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, announces today that the U.S. Food and Drug Administration (‘FDA’) has issued a ‘safe to proceed’ notice for its investigational new drug (‘IND’) application for a Phase 1b study of its novel dry powder formulation of INNA-051. A virus-agnostic intranasal antiviral host defence immunomodulator, INNA-051 is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognizing pathogens and triggering the innate immune response. Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences in a Phase IIa proof-of-principle study using a liquid formulation in an influenza-challenge model, ENA Respiratory has developed an improved dry powder formulation to take into further clinical development. ENA Respiratory’s CEO, Christophe Demaison, PhD said: “We are pleased that the FDA has cleared our IND for our dry powder formulation of INNA-051, which is expected to provide extended shelf life at room temperature. FDA clearance is a significant milestone for the company as it supports late-stage clinical development of INNA-051.” In parallel with the IND application, ENA has submitted ethics approval for a Phase 1b study in Australia. This study is expected to be initiated in mid-2024 with the aim to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of the dry powder formulation of INNA-051 in older adults. ENA Respiratory’s Medicine Development Leader Ruth Tal-Singer, PhD said: “The study is an essential step in supporting our planned international seasonal prophylaxis Phase 2b study in older adults at risk of severe complications from viral respiratory diseases due to conditions including diabetes, cardiovascular or lung diseases. By targeting the innate immune system at the primary site of most viral respiratory infections, INNA-051 has the potential to address an unmet need in this most vulnerable population as a complementary virus-agnostic approach to available vaccines and direct-acting antivirals, which are often virus-specific.” 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 viral clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using an 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 COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$8.18million contract from the U.S. Department of Defence. It is a member BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen potential solutions for future pandemics. For more information, please visit https://enarespiratory.com Follow us on LinkedIn 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