02 May 2023

Verona Pharma to present expanded analyses of positive phase 3 ENHANCE Studies in COPD in Multiple Presentations at ATS 2023

Verona Pharma, a clinical-stage biopharmaceutical company focused on respiratory diseases, announces 12 abstracts, including a mini symposium, and a clinical trials symposium, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) have been accepted by the American Thoracic Society International Conference (“ATS”) 2023. An overview of the ENHANCE trial results will be presented as part of the clinical trials symposium ‘Breaking News: Clinical Trial Results in Pulmonary Medicine’ reserved for highlighting new breakthroughs. The abstracts are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine. Verona Pharma will host a webcast and conference call on Tuesday, May 23, 2023, to review these data.

The abstracts include subgroup data and pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively, covering exacerbations, use of rescue medication and healthcare utilization. Abstracts highlight reductions in the rate and risk of exacerbations with ensifentrine in pooled sub-group analyses of ENHANCE-1 and ENHANCE-2 and a mini symposium discussing the improvements in lung function and reductions in exacerbation rate and risk demonstrated in ENHANCE-2.

Antonio Anzueto, MD, Professor of Medicine and Section, Chief of Pulmonary at South Texas Veterans Healthcare System, commented: “These additional analyses from the ENHANCE studies further demonstrate ensifentrine’s potential to become a first-in-class bronchodilator and non-steroidal anti-inflammatory therapy for COPD. The reduction in the rate and risk of exacerbations across subgroups is exciting. Combined with the significant improvements in lung function, symptom and quality of life measures, as well as the favorable safety profile, these data confirm ensifentrine’s potential to change the treatment paradigm for COPD patients.”

David Zaccardelli, Pharm. D., Verona Pharma’s President and Chief Executive Officer, said: “We are looking forward to providing additional analyses of the positive results from the Phase 3 ENHANCE trials that highlight key areas of interest for physicians. These data further support the potential for ensifentrine to provide a much needed treatment for the millions of symptomatic COPD patients.”

Conference Call and Webcast Information
Verona Pharma will host an investment community webcast and conference call at 4:00 p.m. EDT / 9:00 p.m. BST on Tuesday, May 23, 2023, to discuss the Phase 3 ENHANCE data presented at ATS 2023.

To participate, please dial one of the following numbers and ask to be placed into the Verona Pharma investor call:
+1-833-816-1396 for callers in the United States
+1-412-317-0489 for international callers
A live webcast will be available on the Events and Presentations link on the Investors page of the Company's website, www.veronapharma.com, and the audio replay will be available for 90 days.

Details of Verona Pharma’s abstracts and the symposia are listed below and linked to the ATS website.

Clinical Trials Symposium: Effect of Ensifentrine, a novel PDE3 and PDE4 inhibitor, on lung function, symptoms and exacerbations in patients with COPD: The ENHANCE Trials
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: B13 – Breaking News: Clinical Trial Results in Pulmonary Medicine

Mini Symposium: Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function and Reduces Exacerbation Rate and Risk in Phase 3 ENHANCE-2 Trial
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: C15 – Emerging COPD Diagnostics and Treatments

Abstract: P101 – Twice-daily, Nebulized Ensifentrine Produced Significant Improvement in Week 12 Lung Function: Subgroup Analysis in the Phase 3 Trial ENHANCE-2
Participant: Kathleen Rickard, Chief Medical Officer, Verona Pharma
Session: B22 – New Treatments and Novel Targets for COPD and Alpha-1

Abstract: P102 – Ensifentrine Reduced Healthcare Resource Utilization in Subjects With COPD: Results From ENHANCE-2, a Phase 3 Trial of Ensifentrine, a Dual PDE3/4 Inhibitor
Participant: Igor Barjaktarevic, MD, Medical Director, COPD Program, UCLA Division of Pulmonary & Critical Care Medicine
Session: B22 – New Treatments and Novel Targets for COPD and Alpha-1

Abstract: P166 – Treatment With Ensifentrine, a Dual PDE3 and PDE4 Inhibitor, Significantly Reduced Exacerbation Rate and Risk in Subjects With COPD: Sub-group Results from the Phase 3 Trial, ENHANCE-2
Participant: Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P167 – Ensifentrine, a Dual Inhibitor of PDE3 and PDE4, Reduces the Risk of Exacerbation Regardless of Background Medication Use: A Sub-group Analysis of ENHANCE-2, a Phase 3 Trial
Participant: Gary T. Ferguson, MD, Director of the Pulmonary Research Institute of Southeast Michigan
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P168 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, in Moderate and Severe COPD: Symptoms, Quality of Life and Health Status From the Phase 3 Trial ENHANCE-2
Participant: Tara Rheault, Senior Vice President, R&D, Verona Pharma
Session: C40 – Clinical Trials and Novel Interventions in COPD

Abstract: P171 – Safety Results From Dual PDE3/4 Inhibitor Ensifentrine: Gastrointestinal and Cardiovascular Safety From a 24-week Phase 3 Trial, ENHANCE-2
Participant: Thomas Siler, MD, President at Midwest Chest Consultants
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P172 – Twice-daily, Nebulized Ensifentrine Significantly Improves Lung Function: Sub-group Analysis in the Phase 3 Trial, ENHANCE-1
Participant: Thomas Siler, MD, President at Midwest Chest Consultants
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P173 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function, Symptoms, Quality of Life and Reduces Exacerbation Rate and Risk in Patients With COPD: Results From Replicate Phase 3 Trials
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P174 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Improves Lung Function, Symptoms, Quality of Life and Reduces Exacerbation Rate and Risk in the ENHANCE-1 Phase 3 Trial of Ensifentrine in COPD
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P175 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Significantly Improves COPD Symptoms and Quality of Life in the Phase 3 ENHANCE-1 Trial
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: C40 – Clinical Trials and Novel Interventions in COPD

Late-breaking Abstract: P176 – Ensifentrine, a Novel Dual Phosphodiesterase (PDE) 3 and 4 Inhibitor, Significantly Reduces Annualized Exacerbations and Delays the Time to First Exacerbation in COPD: Pooled Sub-Group Analyses of ENHANCE-1 and ENHANCE-2 Phase 3 Trials
Participant: Igor Barjaktarevic, MD, Medical Director, COPD Program, UCLA Division of Pulmonary & Critical Care Medicine
Session: C40 – Clinical Trials and Novel Interventions in COPD

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