VRNA - Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024 | Benzinga
PDUFA Target Action Date of June 26, 2024
Eight posters including two oral presentations support potential of ensifentrine,
an investigational, first-in-class, selective, dual inhibitor of PDE3 and PDE4
LONDON and RALEIGH, N.C., May 02, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (NASDAQ:VRNA) ("Verona Pharma" or the "Company"), announces eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at the American Thoracic Society International Conference ("ATS") 2024. Pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium' designed to highlight new breakthroughs. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.
Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 ("PDE3 and PDE4") that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the US FDA, and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.
The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 demonstrating statistically significant improvements in lung function across both primary and secondary endpoints. In a pre-specified endpoint, ensifentrine substantially reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The posters will summarize the efficacy and safety endpoints of ensifentrine when added to a long-acting muscarinic antagonist ("LAMA") or a long-acting beta-agonist/inhaled corticosteroids ("LABA/ICS"), reductions in the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations, and the impact of ensifentrine on improving dyspnea. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase ("PDE") in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.
Frank Sciurba, MD, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, commented: "These pooled analyses from the ENHANCE studies provide further evidence of ensifentrine's potential to become an important therapy in a broad population of COPD patients. The substantial reduction in exacerbation rate and risk with ensifentrine is particularly exciting for patients and physicians."
Details of Verona Pharma's posters and the symposia are listed below and linked to the ATS website.
Late-Breaking Mini Symposium: Ensifentrine Reduces Exacerbation Frequency and Delays Progression from Gold B to Gold E
Presenter: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B14 – Late Breaking Abstracts: Science that will impact clinical care
Mini Symposium: Ensifentrine added on to LAMA Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects with Moderate-to-Severe COPD
Presenter: Mark Dransfield, MD, University of Alabama Birmingham & Birmingham VA Medical Center
Session: C95 – New clinical trial results in chronic lung disease
Poster: P624 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Reduced Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD Regardless of Baseline Blood Eosinophils
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging
Poster: P625 – Ensifentrine Added on to LABA/ICS Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects With Moderate-to-Severe COPD
Presenter: Nathan Marchetti, MD, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging