Verona Pharma Completes Enrollment in Phase 2b Clinical Trial with Nebulized Ensifentrine in moderate-to-severe COPD
Results to Inform Development Plan and Dose Selection for Phase 3
LONDON, Oct. 17, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces that it has randomized the last patient in its Phase 2b dose-ranging study evaluating the effect of nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”).
Ensifentrine has the potential to be the first novel class of bronchodilator in over 40 years, and the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The addition of nebulized ensifentrine to symptomatic COPD patients already treated with standard-of-care medicines represents a significant market opportunity.
- Enrollment completed on schedule with data expected around year end 2019
- Preparations underway for End-of-Phase 2 meeting with the U.S. FDA expected in the first half of 2020
- Commencement of Phase 3 trials expected in 2020
“We remain on track to deliver data from this important Phase 2b clinical trial in patients with moderate-to-severe COPD around year end 2019,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “We expect this second Phase 2 study with nebulized ensifentrine in COPD to help inform our planned Phase 3 clinical development program, which we expect to start in 2020. Millions of COPD patients urgently need better treatments as they remain symptomatic despite maximum treatment with currently available therapies. We believe ensifentrine, with its unique mode of action and clinical profile, will have an important role in treating these patients.”
This four-week randomized, double-blind, placebo-controlled dose-ranging Phase 2b trial enrolled a total of 416 patients with moderate-to-severe symptomatic COPD at 46 sites in the U.S. The trial is designed to evaluate the safety and efficacy of nebulized ensifentrine as an add-on to inhaled tiotropium, a long acting anti-muscarinic (“LAMA”) commonly used to treat patients with COPD.
Patients will receive nebulized ensifentrine at four dose levels: 0.375 mg, 0.75 mg, 1.5 mg and 3.0 mg or placebo twice daily for four weeks. The trial’s primary endpoint is improvement in lung function with ensifentrine after four weeks of treatment, as measured by peak forced expiratory volume in one second (“FEV1”), a standard measure of lung function. Key additional endpoints include other lung function measures, as well as measurements of symptoms associated with COPD and quality of life outcomes. For further information on this clinical trial, please visit ClinicalTrials.gov, NCT03937479.
Verona Pharma is also developing two additional formulations of ensifentrine, a dry powder inhaler (“DPI”) and a pressurized metered-dose inhaler (“pMDI”). In July 2019, the company reported positive data from its Phase 2 trial with the DPI formulation, which demonstrated statistically significant and clinically meaningful dose-dependent improvements in lung function in moderate-to-severe COPD. Verona Pharma is conducting a Phase 2 trial with the pMDI formulation and expects to report data from the first part of the trial in the fourth quarter of 2019, with final data expected in the first half of 2020.
COPD is a progressive and life-threatening respiratory disease without a cure. The World Health Organization estimates that it will become the third leading cause of death worldwide by 2030. The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as getting out of bed, showering, eating and walking. In the United States alone, the total annual medical costs related to COPD are projected to rise to $49 billion in 2020. About 1.2 million US COPD patients on dual/triple inhaled therapy (LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.
Nebulized ensifentrine (RPL554) has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness, in Verona Pharma’s prior 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 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 800 people to date.
About Verona Pharma plc
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. Verona Pharma’s product candidate, ensifentrine, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown to act as both a bronchodilator and an anti-inflammatory agent in a single compound. Three formulations of ensifentrine are under development for the treatment COPD: nebulized ensifentrine is currently in Phase 2b clinical development for the maintenance treatment of COPD and is planned to enter Phase 3 trials for this indication in 2020; a dry powder inhaler (“DPI”) formulation reported positive Phase 2 data in August 2019; a pressurized metered-dose inhaler (“pMDI”) formulation expects to report Phase 2 single dose data in the fourth quarter of 2019, with final data expected in the first half of 2020. Verona Pharma may also develop ensifentrine for the treatment of cystic fibrosis and asthma.
For more information, please visit veronapharma.com
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, the development of ensifentrine, including the design of clinical trials, the progress and timing of clinical trials and data and meetings with the U.S. FDA, estimates of medical costs for COPD and its status as a leading cause of death worldwide, ensifentrine as the first novel class of bronchodilator in over 40 years and the first to combine bronchodilator and anti-inflammatory activities and a first-in-class phosphodiesterase 3 and 4 inhibitor, the market opportunity for ensifentrine, the Phase 2b clinical trial with nebulized ensifentrine informing the Phase 3 clinical development program, the impact of ensifentrine in treating COPD patients, and plans to develop ensifentrine for the treatment of cystic fibrosis and asthma.
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; potential delays in enrolling patients, which could adversely affect our research and development efforts and the completion of our Phase 2b trial; 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, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2019, 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.
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