Verona Pharma submits a new drug application to the US FDA for ensiphentrin for the maintenance treatment of COPD

LONDON & RALEIGH, NC, June 27, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (Verona Pharma or the Company) announces the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the approval of ensifentrin for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Ensifentrin is a dual selective inhibitor of phosphodiesterase 3 and 4 enzymes that combines bronchodilator and nonsteroidal anti-inflammatory activities in a single molecule. If approved, it should be the first new mechanism available to treat COPD in more than 10 years.

Millions of symptomatic COPD patients in the United States are in urgent need of new treatment options, said David Zaccardelli, Pharm. D., President and CEO of Verona Pharma. The submission of the NDA for ensifentrin is a significant milestone toward our goal of bringing this potential first-in-class therapy to COPD patients, and we look forward to working with the FDA as they review them.

The NDA contains data from the positive Phase 3 ENHANCE studies and other ensifentrin clinical studies, including data from approximately 3,000 subjects.

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About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharmas’ product candidate, ensifentrin, has the potential to be the first nonsteroidal therapy for the treatment of respiratory disease that combines bronchodilator and anti-inflammatory activities in a single compound. The Company evaluated nebulized ensifentrine in its ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD therapy) Phase 3 clinical program for the maintenance treatment of COPD. Ensifentrin met the primary endpoint in both the ENHANCE-1 and ENHANCE-2 studies demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrin substantially reduced the rate and risk of COPD exacerbations in the pooled analysis of ENHANCE-1 and ENHANCE-2. In the second quarter of 2023, Verona Pharma submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ensifentrin for the maintenance treatment of patients with COPD. Two additional ensifentrine formulations were evaluated in Phase 2 trials for the treatment of COPD: dry powder inhaler (DPI) and pressurized metered dose inhaler (pMDI). Ensifentrin has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, visit www.veronapharma.com.

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Forward-Looking Statements

This press release contains forward-looking statements. All statements 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 ensiphentrin to be the first available new mechanism for treatment of COPD in more than 10 years and the first non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory benefits in a single compound, the potential of ensiphentrin in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of 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 could cause our actual results, performance or achievements to be materially different from our expectations expressed or implied in forward-looking statements, including, but without limitation, the following: our limited operational history; our need for additional funding to complete the development and commercialization of ensiphentrin, which may not be available and which could force us to delay, scale back, or eliminate our development or commercialization efforts; our business’s confidence in the success of enshenentrin, our only product candidate in development; economic, political, regulatory and other risks associated with international operations; the lengthy and costly clinical development process of drugs, with 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 fail to develop ensifentrin for multiple indications; our ability to obtain approval and commercialization of enshenentrin in several major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensors; our inability to realize anticipated benefits under our licenses to third parties for the development and commercialization of ensifentrin, our future growth and our ability to compete depend on us retaining our key personnel and hiring others qualified personnel; material differences between our main data and the final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to such parties’ ability to successfully develop and commercialize ensifentrin; patent lawsuits involving ensiphentrin and the possibility that our patents may be held invalid or unenforceable; lawsuits relating to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, the unavailability of certain tax credits or relief, 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, geopolitical actions and unforeseen events, including health epidemics or pandemics. These and other important factors under the Risk Factors heading 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 in our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements contained in this press release. These forward-looking statements represent management’s estimates as of the date of this press release. While we may choose to update these forward-looking statements in the future, we disclaim any obligation to do so, even if subsequent events change our views. These forward-looking statements should not be relied upon to represent our views as of any date after the date of this press release.