Verona Pharma completes enrollment in ENHANCE-1 48-week subset
LONDON and RALEIGH, N.C., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces enrollment completed in the 48-week subset of the ENHANCE-1 trial in December 2021. The ENHANCE-2 trial has completed screening with 788 subjects randomized as of January 4, 2022, and full enrollment is expected by the end of January 2022. The Phase 3 ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) program is evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).
“This is a significant milestone for Verona Pharma on our path to delivering ensifentrine to COPD patients,” said David Zaccardelli, Pharm.D., President and Chief Executive Officer. “The fully enrolled 48-week subset of ENHANCE-1 is a critical driver of delivering top-line data and we expect to complete enrollment of the 24-week subset of the ENHANCE-1 trial in the second quarter of 2022.
“Our models predict top-line data from ENHANCE-2 are expected in the third quarter of 2022 and from ENHANCE-1 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. We look forward to reporting top-line data this year and working with the regulatory authorities to bring our first-in-class product candidate to the millions of COPD patients worldwide who remain symptomatic.”
Although it has not finalized its full financial results for the fourth quarter and fiscal year ended December 31, 2021, the Company expects to report it had approximately $148.4 million in cash and cash equivalents as of December 31, 2021 (December 31, 2020: $188.0 million). Verona believes its cash and cash equivalents at December 31, 2021, expected cash receipts from the U.K. tax credit program and funding expected to be available under the $30.0 million financing facility secured in November 2020, will enable the Company to fund its planned operating expenses and capital expenditure requirements through at least the end 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 patients with 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 1,300 subjects to date.
About the ENHANCE program
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.
Further information about this study can be found at www.clinicaltrials.gov, NCT04535986 (ENHANCE-1) and NCT04542057 (ENHANCE-2).
* FEV1: Forced Expiratory Volume in one second, a standard measure of lung function
For further information please contact:
Verona Pharma plc US Tel: +1-833-417-0262
UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications firstname.lastname@example.org
(US Investor Enquiries) Tel: +1-212-600-1902
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Optimum Strategic Communications
(International Media and European Investor Enquiries) Tel: +44 (0)203 882 9621
Mary Clark / Stella Lempidaki / Zoe Bolt
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 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 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. Two additional formulations of ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler (“DPI”) and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com
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