Verona Pharma Completes Enrollment in Phase 3 COPD Trial

 Top-line Data Expected in the Third Quarter of 2022

Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, today announces it has completed patient enrollment with more than 800 subjects randomized in the ENHANCE-2 trial, evaluating ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”). Top-line data are expected in the third quarter of 2022.

“Completing enrollment in the Phase 3 ENHANCE-2 trial with more than 800 subjects is an important accomplishment for Verona Pharma,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are pleased to achieve our recruitment targets during the ongoing global pandemic.”

“We expect to report top-line data from ENHANCE-2 in the third quarter of 2022 and from ENHANCE-1 around the end of 2022. We look forward to reporting these results and working with the regulatory authorities to address the urgent need for a novel treatment for COPD.”

The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program consists of two double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) evaluating nebulized ensifentrine for the maintenance treatment of COPD. The 48-week subset of the ENHANCE-1 trial completed enrollment of approximately 400 subjects in December 2021, which was first reported on January 5, 2022. Enrollment in the 24-week subset of ENHANCE-1 is expected to complete in the second quarter of 2022. Data for both subsets of ENHANCE-1 are expected around the end of 2022. Conditional upon positive results, the Company intends to file a New Drug Application (“NDA”) with the US Food & Drug Administration (“FDA”) in the first half of 2023.

Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. In prior clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 subjects to date.

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