Ohtuvayre (ensifentrine nebulized) / Verona Pharma, Ligand, Nuance Biotech - LARVOL DELTA

Treating chronic obstructive pulmonary disease with ensifentrine: a systematic review. (PubMed, Front Med (Lausanne)) - "Ensifentrine consistently improved pulmonary function tests and symptom scores with a safe adverse effect profile. This systematic review supports the clinical benefits of ensifentrine in patients with moderate to severe COPD."

Clinical • Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of ensifentrine on lung function and exacerbations in patients with COPD according to baseline dyspnea (ERS 2025) - "Significant improvements in lung function and reduction in the rate and risk of moderate/severe exacerbations were demonstrated with ensifentrine, regardless of baseline mMRC. These findings support the use of ensifentrine in a broad population of patients with moderate to severe COPD."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The effect of ensifentrine on COPD symptoms and quality of life according to baseline dyspnea level (ERS 2025) - "Treatment with ensifentrine produced early, sustained, and clinically meaningful improvements in symptoms and quality of life in patients with moderate-to-severe COPD, regardless of baseline dyspnea level."

HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Ensifentrine induces anti-inflammatory effects in isolated airways from COPD donors (ERS 2025) - "These findings support the potential of ensifentrine as an adjunctive therapy in COPD management and help explain its effectiveness in reducing the risk of exacerbation, as evidenced by the ENHANCE trials. Funding: Verona Pharma plc."

Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • CSF2 • CXCL8 • IL10 • IL1B • IL33 • IL6 • TGFB1 • TNFA • TSLP

Ensifentrine synergistically relaxes hyperreactive human bronchi from COPD donors in combination with ICS, LABA, and LAMA (ERS 2025) - "Relaxant responses were measured in epithelium intact (EP+) and denuded (EP-) bronchi pre-contracted with carbachol (EC70) and stimulated by electrical field stimulation (EFS; 3-25 Hz)...Synergy was observed at low ensifentrine concentrations (EC30) when combined with GB (+17.50±3.08%), BDP/FF (+18.65±6.26%), FF/GB (+19.28±3.77%), BDP/FF/GB (+19.39±3.06%); additive effect resulted with FF...This suggests ensifentrine is a valuable COPD adjunct, supported by Phase III ENHANCE trial data. Funding: Verona Pharma plc."

Combination therapy • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Verona Pharma to Present Additional Analyses of the Phase 3 ENHANCE Studies in COPD at ERS International Congress 2025 (GlobeNewswire)

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

1118: COPD Management: Advanced Pharmacological Options (CHEST 2025) - "This session will address medication class selection in COPD highlighting considerations for newly approved options (ensifentrine and dupilumab) and how they fit in with existing therapies. Review the evidence for ensifentrine, roflumilast, and azithromycin and provide a framework for drug selection 3. Learn about the currently available and emerging biologic therapeutics in the management of COPD"

Metastases • Chronic Obstructive Pulmonary Disease • Eosinophilia • Immunology • Respiratory Diseases

ENSIFENTRINE IMPROVED LUNG FUNCTION, SYMPTOMS, QUALITY OF LIFE, AND EXACERBATION RATE AND RISK REGARDLESS OF SEX (CHEST 2025) - No abstract available

HEOR • Pulmonary Disease • Respiratory Diseases

ENSIFENTRINE IMPROVED LUNG FUNCTION, SYMPTOMS, AND QUALITY OF LIFE REGARDLESS OF EXACERBATION HISTORY (CHEST 2025) - No abstract available

HEOR • Pulmonary Disease • Respiratory Diseases

ENSIFENTRINE IMPROVED SLEEP IN PATIENTS WITH MODERATE-TO-SEVERE COPD IN THE PHASE 3 ENHANCE TRIALS (CHEST 2025) - No abstract available

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A comprehensive systematic review and meta-analysis of ensifentrine in COPD: dose-dependent effects, safety profile, and GRADE-based certainty of evidence. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Nevertheless, further studies with extended long-term follow-up are essential to fully assess the sustained efficacy and safety of ensifentrine and support its optimal therapeutic integration. CLINICAL TRIAL NUMBER: Not applicable."

Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Bridging Clinical Evidence and Practice: The Role of Ensifentrine in COPD Treatment – Asthma and COPD Section (CHEST 2025) - No abstract available

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Enrolling by invitation | Sponsor: Verona Pharma plc | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Recruiting | Sponsor: Verona Pharma plc | Enrolling by invitation ➔ Recruiting

Enrollment status • Monotherapy • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

7827: Bridging Clinical Evidence and Practice: The Role of Ensifentrine in COPD Treatment – Asthma and COPD Section (CHEST 2025) - "Additionally, this session will evaluate strategies to integrate ensifentrine and explore barriers to implementation while synthesizing clinical evidence with experiential insights from outpatient care settings. Through this comprehensive approach, the session aims to foster critical thinking and collaborative dialogue on how to optimize therapeutic outcomes using ensifentrine, ultimately improving patient-centered care in COPD management."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ENSIFENTRINE IMPROVED SYMPTOMS, DYSPNEA, AND QUALITY OF LIFE IN PATIENTS WITH COPD WHO DID NOT EXACERBATE DURING THE ENHANCE TRIALS (CHEST 2025) - No abstract available

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

EFFICACY OF ENSIFENTRINE IN PATIENTS WITH A HISTORY OF COPD EXACERBATIONS AND EOSINOPHILS LESS THAN 300 CELLS/µL (CHEST 2025) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Verona Pharma plc

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Ensifentrine Plus a Long-Acting Muscarinic Antagonist in COPD: A Trifunctional Dual Bronchodilation Perspective. (PubMed, Drugs) - "Future research should evaluate long-term outcomes, optimal placement within treatment algorithms, and potential benefits of dry powder or metered-dose formulations. Overall, ensifentrine, especially in combination with a LAMA, may redefine maintenance therapy in COPD, offering a steroid-sparing alternative grounded in mechanistic synergy and clinical efficacy."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Merck & Co. close to $10B deal for Verona: report (Firstwordpharma Press Release) - "Merck & Co. is looking to buy Verona Pharma for around $10 billion as it continues to seek ways to plug the looming revenue hole from upcoming patent expiration on its key cancer drug Keytruda (pembrolizumab). A deal for Verona, would give Merck the chronic obstructive pulmonary disease (COPD) medicine Ohtuvayre (ensifentrine), which analysts predict could generate peak annual sales of nearly $4 billion....Merck and Verona are in advanced talks over an agreement, which would be priced at $107 per share — a 23% premium to the latter's closing price on July 8."

M&A • Chronic Obstructive Pulmonary Disease

Ensifentrine: A Novel Option for Maintenance of Chronic Obstructive Pulmonary Disease. (PubMed, J Pharm Technol) - "Data Sources: A literature search of studies took place between October 2024 and December 2024 on PubMed using the terms ensifentrine, roflumilast, Ohtuvayre™ and ensifentrine chronic obstructive pulmonary disease (COPD). The development and approval of ensifentrine for the maintenance of COPD demonstrates an advancement in patient care for a disease with significant morbidity and mortality. Ensifentrine could be a viable option as adjunct therapy for patients still experiencing symptoms despite treatment with currently recommended therapies."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and safety of ensifentrine in treatment of COPD: a systematic review and meta-analysis of clinical trials. (PubMed, Ther Adv Respir Dis) - "In conclusion, owing to its dual effects, ensifentrine has a significant impact on improving pulmonary function and quality of life with minimal side effects. Promising results are expected if implied by synergizing with other drugs, however, more studies are needed to study the long-term effect on disease progression."

Clinical • Journal • Retrospective data • Review • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD (clinicaltrials.gov) - P2 | N=480 | Not yet recruiting | Sponsor: Verona Pharma plc

Monotherapy • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ENHANCE-CHINA: A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=526 | Completed | Sponsor: Nuance Pharma (shanghai) Co., Ltd | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Effects of Ensifentrine, a Dual Phosphodiesterase (PDE)3 and PDE4 Inhibitor, on Lung Fibrosis in a Rat Bleomycin Model (ATS 2025) - "Day0-20: rats administered nintedanib (100 mg/kg) or placebo orally, or inhaled ensifentrine vehicle placebo once-daily (QD). Once daily inhaled therapeutic administration of ensifentrine at 3 mg/kg from Day7 post-BLM challenge resulted in both anti-inflammatory and anti-fibrotic effects in this bleomycin induced lung fibrosis model. Significant reductions in BAL total cell inflammatory infiltrate were primarily driven by a reduction in mononuclear cells (macrophages). TGF-β levels were significantly reduced in addition to a 16% decrease in the modified Ashcroft score vs inhaled placebo."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • TGFB1