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

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

The effect of ensifentrine on lung function and exacerbations in patients with COPD according to baseline dyspnea (ERS 2025) - No abstract available

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) - No abstract available

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

Ensifentrine induces anti-inflammatory effects in isolated airways from COPD donors (ERS 2025) - No abstract available

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Ensifentrine synergistically relaxes hyperreactive human bronchi from COPD donors in combination with ICS, LABA, and LAMA (ERS 2025) - No abstract available

Combination therapy • Chronic Obstructive Pulmonary Disease • Immunology • 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

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

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

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

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

Ensifentrine Reduced Exacerbation Rate Regardless of FEV1 Improvement: A Post-hoc Pooled Analysis (ATS 2025) - "Ensifentrine treatment resulted in substantial reductions in exacerbations over 24 weeks, regardless of the extent of lung function improvement. Given that most patients with COPD have irreversible airway obstruction and have limited response to bronchodilators, it is important that new treatments for COPD provide benefit across a broad population. Here, the large reduction in exacerbation rate in patients with limited FEV1 response supports that ensifentrine works through additional mechanisms such as non-steroidal anti-inflammatory effects."

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

Ensifentrine Monotherapy Reduced Dyspnea and Improved Quality of Life in Patients With Symptomatic, Moderate-to-Severe COPD (ATS 2025) - "Ensifentrine improved dyspnea, COPD symptoms and health-related quality of life, and reduced rescue medication use vs placebo in patients not taking long-acting COPD medications. Nebulized ensifentrine offers a novel, non-steroidal mechanism that can provide meaningful improvements as a monotherapy in patients with symptomatic, moderate-to-severe COPD."

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

Ensifentrine Improved Lung Function and Reduced Exacerbations in Patients With COPD and Concomitant Cardiac Disorders (ATS 2025) - "Ensifentrine treatment resulted in significant improvements in lung function and a reduction in the moderate/severe exacerbation rate vs placebo for patients with COPD and concomitant cardiac disorders. Nebulized ensifentrine may offer a novel, non-steroidal anti-inflammatory mechanism for patients with symptomatic moderate-to-severe COPD and concomitant cardiac disorders."

Clinical • Cardiovascular • Chronic Obstructive Pulmonary Disease • Coronary Artery Disease • Heart Failure • Immunology • Respiratory Diseases

Ensifentrine Improved Lung Function and Reduced Exacerbation Rate in Patients With COPD and Concomitant Type 2 Diabetes (ATS 2025) - "In patients with COPD and T2DM, ensifentrine treatment resulted in significant improvements in lung function and a numerical reduction in the moderate/severe exacerbation rate vs placebo. Given concerns about the risks of triple therapy in patients with T2DM, this data supports that ensifentrine has the potential for clinically meaningful benefits in this population by offering a novel, non-steroidal, anti-inflammatory mechanism of action."

Clinical • Chronic Obstructive Pulmonary Disease • Diabetes • Immunology • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

Ensifentrine as a Novel Treatment for Chronic Obstructive Pulmonary Disease: A Meta-Analysis (ATS 2025) - "Ensifentrine consistently improved pulmonary function tests and symptom scores with a safe adverse effect profile. This meta-analysis supports the clinical benefits of ensifentrine in patients with moderate to severe COPD."

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

Efficacy of Ensifentrine in Chronic Obstructive Pulmonary Disease (COPD): A Meta-analysis of Randomized Controlled Trials (ATS 2025) - "Ensifentrine demonstrated significant improvements in lung function and symptom scores compared to placebo in COPD patients, with early benefits at 6 weeks sustained over 24 weeks. This dual-action PDE3 and PDE4 inhibitor shows promise as a therapeutic option for patients who remain symptomatic despite standard treatments. Further long-term studies are needed to confirm these findings and define the role of ensifentrine in COPD management."

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

Ensifentrine Monotherapy Improved Lung Function and Reduced Exacerbation Rate and Risk in Symptomatic Patients With Moderate-to-Severe COPD (ATS 2025) - "Ensifentrine monotherapy produced significant improvements in lung function and reduced moderate/severe exacerbation rate and risk vs placebo in patients not currently receiving concomitant long-acting maintenance medication. Nebulized ensifentrine monotherapy offers a novel, non-steroidal, anti-inflammatory mechanism of action that provides meaningful improvement in lung function and reduction in exacerbation burden in patients with symptomatic, moderate-to-severe COPD."

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

Ensifentrine Improved Respiratory Symptoms and Quality of Life in Patients With COPD and Concomitant Type 2 Diabetes (ATS 2025) - "Ensifentrine improved patient-reported outcomes for respiratory symptoms, including dyspnea, and health-related quality of life in a pooled population of patients with COPD and T2DM over 24 weeks. In patients with moderate-to-severe COPD and T2DM, nebulized ensifentrine offers a non-steroidal, novel mechanism of action with meaningful impacts on symptoms and quality of life."

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Diabetes • Immunology • Inflammation • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus