Verona Pharma Announces Publication of Phase 3 ENHANCE Data in the American Journal of Respiratory and Critical Care Medicine

LONDON and RALEIGH, N.C., June 28, 2023 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the American Journal of Respiratory and Critical Care Medicine (“AJRCCM”) has published results from its Phase 3 ENHANCE trials evaluating ensifentrine in chronic obstructive pulmonary disease (“COPD”).

The publication reports results from Verona Pharma’s successful ENHANCE trials demonstrating improvements with ensifentrine in lung function, symptoms and quality of life measures, as well as a substantial reduction in the rate and risk of COPD exacerbations and a favourable safety profile. The manuscript, entitled ‘Ensifentrine, a Novel PDE3 and PDE4 Inhibitor for the Treatment of COPD: Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Trials (The ENHANCE Trials)’, is available online here and will be published in an upcoming issue of AJRCCM. It follows announcements of top-line data from the ENHANCE-1 and ENHANCE-2 trials in December and August 2022, respectively.

Data from the ENHANCE program formed the basis of Verona Pharma’s New Drug Application (“NDA”), which was submitted in June 2023 to the US Food and Drug Administration (“FDA”) for the approval of ensifentrine for the maintenance treatment of patients with COPD.

Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. If approved, it is expected to be the first novel mechanism available for the treatment of COPD in more than 10 years.

“Despite available treatment regimens, millions of patients with COPD continue to struggle with debilitating, uncontrolled symptoms from this progressive condition and physicians are looking to novel treatment options to improve patient outcomes,” said Antonio Anzueto, MD, Professor of Medicine and Section Chief of Pulmonary at South Texas Veterans Healthcare System. “The ENHANCE trials demonstrate ensifentrine’s outstanding ability to reduce the rate and risk of COPD exacerbations and to provide meaningful improvements in lung function and symptoms in a broad COPD population. I believe ensifentrine, with its novel bronchodilator and non-steroidal anti-inflammatory activity, has the potential to change the treatment paradigm for COPD patients.”

About the ENHANCE program

The two randomized, double-blind, placebo-controlled trials (ENHANCE-1 and ENHANCE-2) evaluated the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA or a LABA, compared to placebo, and approximately 20% of subjects received inhaled corticosteroids with their long-acting bronchodilator. The two trials replicated measurements of efficacy and safety data over 24 weeks and ENHANCE-1 also evaluated long-term safety and exacerbations over 48 weeks.

• Patient Population: ENHANCE-1 and ENHANCE-2 trials included 763 and 790 moderate to severe, symptomatic, COPD subjects, respectively, at sites primarily in North America and Europe.
• Dose/Duration: Subjects were randomized to receive a 3 mg nebulized dose of ensifentrine or nebulized placebo twice daily for 24 weeks in ENHANCE-2 and 24 or 48 weeks in ENHANCE-1.
• Primary Endpoint: Improvement in lung function with ensifentrine as measured by average FEV₁ AUC 0-12 hours post dose at week 12.
• Secondary and Other Endpoints: Lung function endpoints including peak and morning trough FEV₁, COPD symptoms and health-related quality of life through 24 weeks via SGRQ and E-RS questionnaires, and exacerbation rate and risk over 24 weeks and in the 48 week subset of ENHANCE-1.
• Safety: Assessed over 24 weeks in both trials and over 48 weeks in 370 subjects in ENHANCE-1.
  
  

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About the American Journal of Respiratory and Critical Care Medicine

The American Journal of Respiratory and Critical Care Medicine, also known as the “Blue Journal”, is a leading peer reviewed journal published by the American Thoracic Society. The publication focuses on human biology and disease, as well as animal and in vitro studies that contribute to the understanding of pathophysiology and treatment of diseases that affect the respiratory system and critically ill patients.

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In the Phase 3 ENHANCE-1 and ENHANCE-2 clinical trials, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 subjects to date.

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 be the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. 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 second quarter of 2023, Verona Pharma submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ensifentrine for the maintenance treatment of patients with COPD. 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 regarding the potential for ensifentrine to be the first novel mechanism available for the treatment of COPD in over 10 years, the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, and the potential to change the treatment paradigm for COPD patients, the ability of ensifentrine to reduce the rate and risk of COPD exacerbations and to provide meaningful improvements in lung function and symptoms in a broad COPD population, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as 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 Report on Form 10-Q for the quarter ended March 31, 2023 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.