Verona Pharma to Present Additional Analyses of Positive Phase 3 ENHANCE Studies in COPD at CHEST 2023

PDUFA Target Action Date of June 26, 2024

Pooled analysis and subgroup data further support potential of ensifentrine, an investigational, novel, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces four presentations 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 CHEST Annual Meeting (“CHEST”) 2023. The data are published in the CHEST Annual Meeting on-line supplement. Ensifentrine is Verona Pharma’s investigational dual PDE3 and PDE4 inhibitor, a potential first-in-class product currently under review by the US FDA for the maintenance treatment of COPD.

The presentations will include pooled analyses from the ENHANCE-1 and ENHANCE-2 studies which demonstrated treatment with ensifentrine resulted in substantial reductions in the rate and risk of COPD exacerbations regardless of recent exacerbation history and was well-tolerated. In addition, the presentations will include subgroup data analyses which demonstrate improvements in lung function, symptoms, quality of life endpoints and reductions in the rate and risk of exacerbations regardless of background therapy as well as reduction in daily rescue medication use.

Frank Sciurba, MD, Associate Professor of Medicine at the University of Pittsburgh School of Medicine commented: “These additional analyses from the ENHANCE program further demonstrate ensifentrine’s potential, if approved, to become an effective novel treatment for COPD patients. Ensifentrine’s combined bronchodilator and non-steroidal anti-inflammatory activity could lead to meaningful benefits in a broad population of COPD patients.

Details of Verona Pharma’s presentations are listed below and linked to the CHEST website:

Presentation: Ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor, reduces exacerbation rate and risk regardless of exacerbation history in pooled ENHANCE trial analyses
Presenter: Frank Sciurba, MD, Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh School of Medicine
Session: Latest Advances in Management of Obstructive Lung Disease

Presentation: Nebulized ensifentrine improves lung function, symptoms, quality of life and reduces exacerbations in symptomatic COPD patients regardless of background LAMA or LABA therapy
Presenter: Thomas Siler, MD, Pulmonary Disease, Saint Charles
Session: Latest Advances in Management of Obstructive Lung Disease

Presentation: Ensifentrine reduces COPD symptoms and rescue medication use over 24 weeks in two Phase 3 trials in symptomatic patients with moderate to severe COPD
Presenter: Frank Sciurba, MD, Pulmonary, Allergy and Critical Care Medicine at the University of Pittsburgh School of Medicine
Session: Latest Advances in Management of Obstructive Lung Disease

Presentation: Pooled safety results over 24 weeks from the ENHANCE program with ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor
Presenter: Thomas Siler, MD, Pulmonary Disease, Saint Charles
Session: Latest Advances in Management of Obstructive Lung Disease

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About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma’s product candidate, ensifentrine, has the potential to become the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule. 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 pooled analysis from ENHANCE-1 and ENHANCE-2. 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. 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”). Ensifentrine has potential applications in 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. 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 mechanism available for the maintenance treatment of COPD in over 10 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory activities in one molecule, and the potential to change the treatment paradigm for COPD patients, the potential of ensifentrine in the treatment of cystic fibrosis, 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, 2022, 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.