Verona Pharma to Present Phase 2b COPD Symptom and Quality of Life Data with Ensifentrine at CHEST 2020

Rhea-AI Summary

Verona Pharma announces the presentation of new analyses from a Phase 2b clinical trial of ensifentrine for chronic obstructive pulmonary disease (COPD) at the CHEST Annual Meeting 2020. The data indicate that adding nebulized ensifentrine to tiotropium provides significant improvements in quality of life and inspiratory capacity over four weeks. Furthermore, additional analyses highlight a rapid bronchodilator response with a pressurized metered-dose inhaler (pMDI) formulation, sustained for 12 hours. This data suggests ensifentrine’s dual mechanism of action may effectively manage COPD symptoms.

Positive

• Nebulized ensifentrine showed significant quality of life improvements in COPD patients with statistically significant results in activity and impacts subscales compared to placebo.
• Clinically meaningful improvement in inspiratory capacity observed after four weeks of treatment.
• Rapid bronchodilatory response sustained for 12 hours after a single dose of ensifentrine delivered via pMDI.

Negative

• None.

Posters highlight ensifentrine’s potential to provide rapid benefits

LONDON and RALEIGH, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that it will present new analyses from a Phase 2b clinical trial with nebulized ensifentrine in chronic obstructive pulmonary disease (“COPD”) at CHEST Annual Meeting (“CHEST”) 2020 taking place on October 18-21. The data are published in the CHEST Annual Meeting online supplement.

The posters present further analysis of Phase 2b data, first reported by Verona Pharma on January 13, 2020, demonstrating that nebulized ensifentrine added to tiotropium (Spiriva^® Respimat^®), a long acting anti-muscarinic (“LAMA”) bronchodilator, provides meaningful additional improvement in quality of life as measured by St. George’s Respiratory Questionnaire: COPD (SGRQ-C). This was shown in symptomatic COPD patients over 4 weeks, including statistically significant improvement in both activity and impacts subscales compared to placebo added on to tiotropium. Importantly, a responder analysis of the proportion of patients achieving a clinically important difference in quality of life on the SGRQ-C showed responses in favor of ensifentrine, which were particularly notable in COPD patients who were not reversible to albuterol. An evaluation of inspiratory capacity over 4 weeks demonstrated a clinically meaningful and statistically significant improvement in inspiratory capacity (“IC”). Improvements in IC have been shown to correlate with improvements in dyspnea, suggesting that ensifentrine improves symptoms and quality of life via a physiological mechanism.

In addition to the Phase 2b data with nebulized ensifentrine, Verona Pharma will highlight Phase 2 data with a pressurized metered dose inhaler (“pMDI”) formulation of ensifentrine. This data showed a rapid and meaningful bronchodilatory response in COPD patients following a single dose of ensifentrine pMDI. This effect was sustained for 12 hours. Data from this study were first reported on March 31, 2020. Notably, the Company will also present pre-clinical data demonstrating the anti-inflammatory effects of ensifentrine, which further support its dual mechanism of action as an inhibitor of phosphodiesterases (“PDE”) 3 and 4.

Details of Verona Pharma’s abstracts are listed below.

e-Poster: P1491 Ensifentrine added to tiotropium over 4 weeks provides additional improvement in COPD quality of life
Author: Kathleen Rickard, M.D., CMO, Verona Pharma
Session: Obstructive Lung Disease Posters

e-Poster: P1490 Ensifentrine added on to tiotropium significantly improves inspiratory capacity in patients with symptomatic COPD
Author: Kathleen Rickard, M.D., CMO, Verona Pharma
Session: Obstructive Lung Disease Posters

e-Poster: P1489 Ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor, provides effective bronchodilation when administered by metered dose inhaler in patients with COPD
Presenter: Tara Rheault, Ph.D., Vice President, R&D and Global Project Management, Verona Pharma
Session: Obstructive Lung Disease Posters

e-Poster: P1944 Anti-inflammatory pharmacology of ensifentrine
Presenter: Tara Rheault, Ph.D., Vice President, R&D and Global Project Management, Verona Pharma
Session: Respiratory Care Posters

For further information, please contact:

Verona Pharma plc	Tel: +44 (0)20 3283 4200
David Zaccardelli, Chief Executive Officer	info@veronapharma.com
Victoria Stewart, Director of Communications
N+1 Singer (Nominated Adviser and UK Broker)	Tel: +44 (0)20 7496 3000
Aubrey Powell / George Tzimas / Iqra Amin
(Corporate Finance)
Tom Salvesen (Corporate Broking)
Optimum Strategic Communications (European Media and Investor Enquiries)	Tel: +44 (0)203 950 9144 verona@optimumcomms.com
Mary Clark / Eva Haas / Shabnam Bashir
Argot Partners (U.S. Investor Enquiries)	Tel: +1 212-600-1902 verona@argotpartners.com
Kimberly Minarovich / Michael Barron

About COPD

COPD is a progressive and life-threatening respiratory disease without a cure. It is the third leading cause of death globally, according to the World Health Organization. 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. U.S. sales of medicines used for chronic maintenance therapy of COPD were $9.6 billion in 2019. About 1.2 million U.S. COPD patients on dual/triple inhaled therapy, long-acting beta-agonist (“LABA”)/long-acting muscarinic antagonist (“LAMA”) +/- inhaled corticosteroid (“ICS”) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.

About Ensifentrine

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 COPD or inflammation triggered by viruses.

Ensifentrine has demonstrated 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 Chronic Obstructive Pulmonary Disease (“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 1,300 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 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 therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. The Company raised gross proceeds of $200 million through a private placement in July 2020 and expects the funds to support its operations and Phase 3 clinical program into 2023. Two additional formulations of ensifentrine are currently in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine is in a pilot clinical study in patients hospitalized with COVID-19 and 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. 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. 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. 

FAQ

What are the results of the Phase 2b trial of ensifentrine presented by Verona Pharma?

The Phase 2b trial results indicated that nebulized ensifentrine added to tiotropium significantly improved quality of life and inspiratory capacity in COPD patients over four weeks.

When is the CHEST Annual Meeting where the ensifentrine data will be presented?

The CHEST Annual Meeting will take place from October 18-21, 2020.

What is ensifentrine and its role in treating COPD?

Ensifentrine is a dual phosphodiesterase 3 and 4 inhibitor that combines bronchodilator and anti-inflammatory effects, which may alleviate symptoms of COPD.

How long does the bronchodilator effect of ensifentrine last?

The bronchodilator effect of ensifentrine when administered via pMDI is sustained for 12 hours after a single dose.

What are the implications of the ensifentrine clinical trial data for COPD treatment?

The data suggests that ensifentrine could offer meaningful improvements in quality of life and symptom management for COPD patients, addressing significant unmet needs in the treatment landscape.