Verona Pharma Initiates Pilot Study with pMDI Ensifentrine in U.S. Patients Hospitalized with COVID-
The study will evaluate the effect of ensifentrine on key outcomes in patients hospitalized with COVID-19 including facilitation of recovery from the viral infection, clinical status improvement and reduction in supplemental oxygen use and progression to mechanical ventilation.
Ensifentrine is a first-in-class product candidate that combines bronchodilator and anti-inflammatory activities in one compound. Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown that ensifentrine improved oxygenation, reduced inflammation in the lungs and enhanced mucus clearance*. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people to date.
About the study
The randomized, double-blind, parallel group pilot study will evaluate the efficacy and safety of pMDI ensifentrine added on to standard of care treatment in patients with COVID-19 compared to standard of care plus placebo.
- Patient Population: Approximately 45 hospitalized patients with COVID-19. Single center study at
University of Alabama at Birmingham.
- Dose/Duration: Patients will be randomized to receive 2 mg of pMDI ensifentrine or placebo, twice-daily for up to 29 days or until discharge if this occurs before 29 days. The clinical status of all patients will be evaluated at Day 29 and Day 60.
- Primary Endpoint: Proportion of patients recovered from COVID-19 and no longer hospitalized at Day 29.
- Secondary Endpoints: Safety and tolerability, improvements in clinical status, time to recovery, supplemental oxygen use, proportion of patients requiring mechanical ventilation and mortality.
Further information about this study can be found at www.clinicaltrials.gov, NCT04527471.
*Franciosi LG, et al., Lancet Respir Med 2013
For further information, please contact:
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|N+1 Singer |
(Nominated Adviser and
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(European Media and Investor Enquiries)
|Tel: +44 (0)203 950 9144 |
|Mary Clark / |
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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 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 people to date.
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, the progress and timing of initiation of clinical trials, the goals and design of clinical trials, patient enrolment and study completion, the potential for ensifentrine to be a first-in-class phosphodiesterase 3 and 4 inhibitor and to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and anti-inflammatory effects in one compound, the potential of ensifentrine to significantly benefit patients with COVID-19 and to be safe and well tolerated in those patients, the potential of ensifentrine to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation triggered by viruses, the ability of the Company to progress the development of ensifentrine and to secure supplies of the drug for ongoing development and commercialization, the sufficiency of funds to supports its operations and Phase 3 clinical program into 2023, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases.
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 clinical trials; 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; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, 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; and our vulnerability to natural disasters, global economic factors and other unexpected events, including health epidemics or pandemics like the novel coronavirus (COVID-19). These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the
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