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Verona Pharma completes patient enrollment in phase 3 ENHANCE-2 trial of ensifentrine for maintenance treatment of COPD

London
Tuesday, January 25, 2022, 12:00 Hrs  [IST]

Verona Pharma plc, a clinical-stage biopharmaceutical company, 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) programme 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.

The two randomized, double-blind, placebo-controlled studies (ENHANCE-1 and ENHANCE-2) will evaluate the efficacy and safety of nebulized ensifentrine as monotherapy and added onto a single bronchodilator, either a LAMA (long acting muscarinic antagonist) or a LABA (long acting beta-agonist), compared to placebo. The two study designs will replicate measurements of efficacy and safety data over 24 weeks and ENHANCE-1 will also evaluate longer-term safety over 48 weeks.

Patient Population: Each study will enroll approximately 800 moderate to severe, symptomatic, COPD patients at sites primarily in the U.S. and Europe.

Dose/Duration: Patients will be 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 as measured by forced expiratory volume* in one second (“FEV1”) over 12 hours with ensifentrine after 12 weeks of treatment.

Key Secondary Endpoints: COPD symptoms and health-related quality of life through 24 weeks via the validated patient reported outcome tools, SGRQ and E-RS. Additional lung function endpoints including peak and morning trough FEV1 will also be assessed.

Safety: Assessed over 24 weeks in both studies and over 48 weeks in approximately 400 patients in ENHANCE-1.

Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with chronic obstructive pulmonary disease or inflammation triggered by viruses.

Ensifentrine has demonstrated statistically significant and clinically meaningful improvements in both lung function and symptoms, including breathlessness, in Verona Pharma’s phase 2 clinical studies in patients with moderate to severe COPD. In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Ensifentrine has been well tolerated in clinical trials involving more than 1,400 subjects to date.

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs.

 

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