Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024

PDUFA Target Action Date of June 26, 2024

Eight posters including two oral presentations support potential of ensifentrine,
an investigational, first-in-class, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., May 02, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at the American Thoracic Society International Conference (“ATS”) 2024. Pooled analysis demonstrating reductions in the rate and risk of exacerbations with ensifentrine will be presented as part of the ‘Late Breaking Mini Symposium’ designed to highlight new breakthroughs. The posters are published on the ATS website and in the publication, American Journal of Respiratory and Critical Care Medicine.

Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the US FDA, and, if approved, is expected to be the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.

The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on December 20, 2022, and August 9, 2022, respectively. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 demonstrating statistically significant improvements in lung function across both primary and secondary endpoints. In a pre-specified endpoint, ensifentrine substantially reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of ENHANCE-1 and ENHANCE-2. The posters will summarize the efficacy and safety endpoints of ensifentrine when added to a long-acting muscarinic antagonist (“LAMA”) or a long-acting beta-agonist/inhaled corticosteroids (“LABA/ICS”), reductions in the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations, and the impact of ensifentrine on improving dyspnea. In addition, the Company will host an exhibition booth exploring the role of phosphodiesterase (“PDE”) in inflammation and lung function impairment in COPD as well as three innovation hub presentations led by clinical experts.

Frank Sciurba, MD, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, commented: “These pooled analyses from the ENHANCE studies provide further evidence of ensifentrine’s potential to become an important therapy in a broad population of COPD patients. The substantial reduction in exacerbation rate and risk with ensifentrine is particularly exciting for patients and physicians.”

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

Late-Breaking Mini Symposium: Ensifentrine Reduces Exacerbation Frequency and Delays Progression from Gold B to Gold E
Presenter: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B14 – Late Breaking Abstracts: Science that will impact clinical care

Mini Symposium: Ensifentrine added on to LAMA Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects with Moderate-to-Severe COPD 
Presenter: Mark Dransfield, MD, University of Alabama Birmingham & Birmingham VA Medical Center
Session: C95 – New clinical trial results in chronic lung disease

Poster: P624 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Reduced Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD Regardless of Baseline Blood Eosinophils
Participant: Frank Sciurba, MD, University of Pittsburgh Medical Center
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P625 – Ensifentrine Added on to LABA/ICS Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects With Moderate-to-Severe COPD
Presenter: Nathan Marchetti, MD, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging

Poster: P704 – Improvements in Breathlessness, COPD Symptoms and Quality of Life Reported With Ensifentrine in a Pooled Analysis of the ENHANCE Trials
Presenter: Dave Singh, Professor of Respiratory Pharmacology at the University of Manchester
Session: A101 – Full metal jacket targeting COPD and chronic airways disease

Poster: P901 – Ensifentrine Added on to LAMA Therapy Improved COPD Symptoms and Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Ravi Kalhan, MD, Pulmonology and Critical Care, Northwestern University
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P909 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Improved Dyspnea in Subjects With Symptomatic, Moderate-to-Severe COPD Over 24 Weeks
Presenter: Donald Mahler, MD, Valley Regional Hospital in Claremont
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

Poster: P911 – Ensifentrine Added on to LABA/ICS Therapy Reduced Dyspnea and Improved Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter: Antonio Anzueto, MD, Medicine/Pulmonary Critical Care, South Texas Veterans Healthcare System
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies

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. In the third quarter of 2023, the US Food and Drug Administration accepted for review the Company’s NDA for ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024. If approved, ensifentrine has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, and the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years. The Company has evaluated nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine substantially reduced the rate and risk of COPD exacerbations in a pooled analysis from ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine have been evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”); and a fixed-dose combination formulation with ensifentrine and glycopyrrolate, a LAMA, is currently under development, also for the treatment of COPD. Ensifentrine also has potential applications in cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

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Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements relating to the timing of the FDA’s potential approval of the NDA for ensifentrine by the PDUFA date of June 26, 2024, or at any other time, statements regarding the potential for ensifentrine to be the first novel inhaled mechanism available for the maintenance treatment of COPD in over 20 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory effects in one molecule, and the potential of ensifentrine to become an important therapy in a broad population of COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, non-cystic fibrosis bronchiectasis, asthma and other respiratory diseases, and the potential of the DPI and pMDI formulations of ensifentrine.

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 following: our limited operating history; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as updated in our Quarterly Reports on Form 10-Q and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.