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Verona Pharma to Present Additional Analyses of the Phase 3 ENHANCE Studies in COPD at ERS International Congress 2025
Globenewswire· 2025-09-16 10:00
Core Insights - Verona Pharma plc is presenting two posters on additional analyses from its Phase 3 ENHANCE studies of Ohtuvayre (ensifentrine) for COPD treatment at the European Respiratory Society International Congress 2025 [1][3] - Ohtuvayre is a first-in-class selective dual inhibitor of PDE3 and PDE4, combining bronchodilator and non-steroidal anti-inflammatory effects, marking the first novel inhaled mechanism for COPD maintenance treatment in over 20 years [2][4] Group 1: Ohtuvayre's Clinical Data - The posters focus on subgroup analyses demonstrating the benefits of ensifentrine on lung function, exacerbation rates, and COPD symptoms, including dyspnea and quality of life based on baseline dyspnea levels [3] - Poster 3613 presents the effect of ensifentrine on COPD symptoms and quality of life, while Poster 3614 discusses its impact on lung function and exacerbations [3] Group 2: Company Overview - Verona Pharma is dedicated to developing innovative therapies for chronic respiratory diseases with significant unmet medical needs, with Ohtuvayre being its first commercial product [6] - The company is also developing a fixed-dose combination of ensifentrine and glycopyrrolate for COPD maintenance treatment [4]
[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on astegolimab in chronic obstructive pulmonary disease
Globenewswire· 2025-07-21 05:00
Core Insights - Roche announced topline results from pivotal phase IIb ALIENTO and phase III ARNASA trials for astegolimab in chronic obstructive pulmonary disease (COPD) patients [1][2][3] Study Results - The phase IIb ALIENTO study met its primary endpoint, showing a statistically significant 15.4% reduction in the annualized exacerbation rate (AER) at 52 weeks with astegolimab administered every two weeks [2][6] - The phase III ARNASA study did not meet its primary endpoint, demonstrating a numerical 14.5% reduction in AER at 52 weeks with the same dosing regimen [2][6] - Both studies showed consistent results across secondary endpoints, with total exacerbations lower than anticipated [2][6] Safety Profile - The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified [2][6] Future Steps - Roche plans to discuss the data with regulatory authorities to evaluate next steps for astegolimab [3][6] - Detailed results from both studies will be shared at an upcoming medical meeting [3][6] About Astegolimab - Astegolimab is a fully human anti-ST2 monoclonal antibody designed to block IL-33 signaling, evaluated in a broad COPD population including former and current smokers [4][6]
Verona Pharma to Present Seven Analyses of the Phase 3 ENHANCE Studies in COPD at ATS 2025
Globenewswire· 2025-05-06 10:00
Core Insights - Verona Pharma plc announces the presentation of ten posters, including seven analyses from its Phase 3 ENHANCE studies on Ohtuvayre (ensifentrine) for COPD treatment at the ATS 2025 conference [1][3] - Ohtuvayre is a first-in-class selective dual inhibitor of PDE3 and PDE4, combining bronchodilator and anti-inflammatory effects, marking the first novel inhaled mechanism for COPD maintenance treatment in over 20 years [2][6] Group 1: Clinical Findings - The ENHANCE posters include subgroup analyses of Ohtuvayre's effects as monotherapy and in patients with comorbid conditions such as cardiac disorders and type 2 diabetes [3] - Ohtuvayre demonstrated improvements in lung function and reduced exacerbation rates in symptomatic patients with moderate-to-severe COPD [4] - A pooled analysis indicated that Ohtuvayre reduced exacerbation rates regardless of FEV1 improvement [4] Group 2: Nonclinical Studies - Nonclinical studies presented include a tissue distribution study in rats showing no brain exposure and a model demonstrating antifibrotic effects of inhaled ensifentrine [3][5] - The effects of ensifentrine on lung fibrosis were evaluated in a rat bleomycin model [5] Group 3: Company Overview - Verona Pharma focuses on developing therapies for chronic respiratory diseases with significant unmet medical needs, with Ohtuvayre being its first commercial product [7] - The company is also developing a fixed-dose combination of ensifentrine and glycopyrrolate for COPD maintenance treatment [6]