Verona Pharma to Present Seven Analyses of the Phase 3 ENHANCE Studies in COPD at ATS 2025

Rhea-AI Summary

Verona Pharma (NASDAQ: VRNA) will present ten posters at the American Thoracic Society Conference (ATS) 2025, including seven additional analyses from Phase 3 ENHANCE studies of Ohtuvayre (ensifentrine) for COPD treatment. Ohtuvayre, a first-in-class dual inhibitor of PDE3 and PDE4 enzymes, represents the first novel inhaled COPD maintenance treatment mechanism in over 20 years. The presentations will highlight subgroup analyses showing Ohtuvayre's effectiveness as monotherapy, its impact on patients with COPD and comorbid conditions (cardiac disorders and type 2 diabetes), and its effect on COPD exacerbations. Additional posters will cover nonclinical studies demonstrating lack of brain exposure in rats and antifibrotic effects in a bleomycin model. The company will also host an exhibition booth featuring presentations by clinical experts.

Insights

Pharmaceutical Research Analyst

Verona's presentations of Ohtuvayre Phase 3 analyses at ATS demonstrate scientific validation for their first-in-class COPD treatment across diverse patient populations.

Verona Pharma's announcement about presenting seven additional analyses from their Phase 3 ENHANCE studies for Ohtuvayre® (ensifentrine) at the American Thoracic Society Conference 2025 represents continued scientific validation of their COPD treatment. Ohtuvayre is positioned as a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 enzymes, combining bronchodilator and anti-inflammatory effects in one molecule – the first novel inhaled mechanism for COPD maintenance treatment in over 20 years.

The scientific presentations cover clinically relevant subgroups, including Ohtuvayre as monotherapy and its effects in COPD patients with cardiac disorders or type 2 diabetes. A notable analysis examines Ohtuvayre's impact on COPD exacerbations regardless of FEV1 improvement, suggesting benefits beyond standard spirometric measures.

Complementing the clinical analyses, nonclinical presentations will address tissue distribution showing lack of brain exposure (potentially a safety advantage) and antifibrotic effects in a rat model. The company will also present real-world data analyzing pneumonia prevalence in COPD patients treated with inhaled corticosteroids.

The involvement of researchers from prestigious institutions like Johns Hopkins, Brigham & Women's Hospital, and UNC Chapel Hill indicates external scientific engagement with Verona's clinical program. These presentations at a major respiratory medicine conference help establish the clinical profile of Ohtuvayre across different COPD patient populations.

Biotechnology Market Analyst

The presentation of multiple analyses from Verona's Phase 3 ENHANCE program demonstrates their commitment to robust scientific communication for Ohtuvayre. These presentations build the scientific narrative around the drug's differentiated dual PDE3/PDE4 inhibitor mechanism for COPD treatment.

Particularly strategic are the subgroup analyses in patients with comorbidities like cardiac disorders and type 2 diabetes, as these represent substantial overlapping populations within the broader COPD market. The company is clearly working to position Ohtuvayre across various patient segments.

The analysis showing exacerbation benefits regardless of FEV1 improvement is especially significant, as exacerbation reduction is a clinically meaningful endpoint affecting healthcare utilization and patient quality of life. This could help differentiate Ohtuvayre from other treatments that primarily focus on lung function improvements.

The nonclinical studies showing lack of brain exposure and potential antifibrotic effects suggest Verona is exploring the full mechanistic profile of their compound beyond its primary indications.

While these scientific presentations represent normal-course development activities, they help build physician awareness and understanding of Ohtuvayre's clinical profile. The breadth of analyses being presented at ATS 2025 indicates Verona is taking a comprehensive approach to establish Ohtuvayre's place in COPD treatment across diverse patient populations.

Analyses support Ohtuvayre® (ensifentrine) as a first-in-class selective dual
inhibitor of PDE3 and PDE4 for a broad COPD population

LONDON and RALEIGH, N.C., May 06, 2025 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces ten posters including seven additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (“COPD”), two from nonclinical studies, and one from a real-world data analysis, will be presented at the American Thoracic Society Conference (“ATS”) 2025. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.

The ENHANCE posters highlight subgroup analyses of patients when used as monotherapy, in patients with COPD and comorbid cardiac disorders and, separately, in patients with COPD and comorbid type 2 diabetes. An analysis of Ohtuvayre’s effect on COPD exacerbations relative to lung function results will also be presented. Nonclinical posters describe a tissue distribution study in rat demonstrating lack of brain exposure, and a bleomycin model in rat demonstrating antifibrotic effects following inhaled ensifentrine dosing. In addition, the Company will have an exhibition booth, 2237, which will host presentations led by clinical experts.

Details of Verona’s posters are listed below and linked to the ATS website.

Poster P275: Ensifentrine Monotherapy Improved Lung Function and Reduced Exacerbation Rate and Risk in Symptomatic Patients With Moderate-to-Severe COPD
Presenter: Isaac Biney, MBChB, University of Tennessee Medical Center
Session: B52 – Hot Topics in COPD

Poster P283: Ensifentrine Improved Lung Function and Reduced Exacerbation Rate in Patients with COPD and Concomitant Type 2 Diabetes 
Presenter: Matthew Moll, MD, Brigham and Women’s Hospital 
Session: B52 – Hot Topics in COPD

Poster P284: Ensifentrine Improved Lung Function and Reduced Exacerbations in Patients with COPD and Concomitant Cardiac Disorders 
Presenter: Nirupama Putcha, MD, Johns Hopkins University 
Session: B52 – Hot Topics in COPD

Poster P285: Ensifentrine Monotherapy Reduced Dyspnea and Improved Quality of Life in Patients With Symptomatic, Moderate-to-Severe COPD 
Presenter: Michael Bradley Drummond, MD, University of North Carolina at Chapel Hill 
Session: B52 – Hot Topics in COPD

Poster P287: Ensifentrine Reduced Exacerbation Rate Regardless of FEV₁ Improvement: A Post-hoc Pooled Analysis 
Presenter: George Washko, MD, Brigham & Women’s Hospital 
Session: B52 – Hot Topics in COPD

Poster P420: Tissue Distribution of 14C-Ensifentrine, a Novel Phosphodiesterase (PDE)3 and PDE4 Inhibitor, in Rats Following a Single Intravenous Dose 
Presenter: Margot Macdonald-Berko, Verona Pharma 
Session: A71 Epithelial Dysfunction, inflammation and cigarette smoke: Drivers of COPD and CF Pathogenesis

Poster P891: Prevalence of Pneumonia According to Age in Patients With COPD Treated With Inhaled Corticosteroids 
Presenter: Trishul Siddharthan, MD, University of Miami 
Session: C49 – What’s New in COPD Phenotyping and Management

Poster P919: Ensifentrine Improved Patient-reported Outcomes, Including Dyspnea, in Patients With COPD and Concomitant Cardiac Disorders 
Presenter: Michael Lester, MD, Vanderbilt University Medical Center 
Session: B30 – Advanced Modalities to Uncover Pathophysiologic Features in COPD

Poster P924: Effects of Ensifentrine, a Dual Phosphodiesterase (PDE)3 and PDE4 Inhibitor, on Lung Fibrosis in a Rat Bleomycin Model 
Presenter: Margot Macdonald-Berko, Verona Pharma 
Session: D29 – From Bench to Bedside: Unraveling Pulmonary Fibrosis Through Cellular Communication and Molecular Pathways

Poster P943: Ensifentrine Improved Respiratory Symptoms and Quality of Life in Patients With COPD and Concomitant Type 2 Diabetes 
Presenter: Auyon Ghosh, MD, Suny Upstate Medical University 
Session: B35 – ‘Omics and Outcomes: Translational Studies Across Lung Diseases

For further information please contact:

Verona Pharma plc	Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications	IR@veronapharma.com
Argot Partners US Investor Enquiries	Tel: +1-212-600-1902 verona@argotpartners.com
Ten Bridge Communications International / US Media Enquiries	Tel: +1-781-316-4424 tbcverona@tenbridgecommunications.com
Wendy Ryan

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre^TM (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre and future poster presentations and academic publications pertaining to Ohtuvayre.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to the efficacy of Ohtuvayre compared to competing drugs; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2025 filed with the Securities and Exchange Commission (“SEC”) on April 29, 2025, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law.

FAQ

What will Verona Pharma (VRNA) present at ATS 2025?

Verona Pharma will present ten posters at ATS 2025, including seven analyses from Phase 3 ENHANCE studies of Ohtuvayre for COPD treatment, two nonclinical studies, and one real-world data analysis.

What makes Ohtuvayre (ensifentrine) unique for COPD treatment?

Ohtuvayre is the first novel inhaled mechanism for COPD maintenance treatment in over 20 years, acting as a first-in-class selective dual inhibitor of PDE3 and PDE4 enzymes that combines bronchodilator and anti-inflammatory effects in one molecule.

What patient subgroups are included in VRNA's ENHANCE studies analysis?

The analyses include patients using Ohtuvayre as monotherapy, patients with COPD and comorbid cardiac disorders, and patients with COPD and comorbid type 2 diabetes.

What additional studies will be presented about Ohtuvayre at ATS 2025?

The presentation will include nonclinical studies showing lack of brain exposure in rats, antifibrotic effects in a bleomycin model, and analysis of Ohtuvayre's effect on COPD exacerbations relative to lung function.