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Top-line data from the study now expected in mid-2018
LONDON, Nov. 07, 2017 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP) (Nasdaq:VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that it has enrolled more than 200 patients in its ongoing Phase 2b study to evaluate RPL554 for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
The four-week, double-blind, placebo-controlled, parallel group Phase 2b study is expected to enroll in total approximately 400 patients with moderate-to-severe COPD at a number of sites across Europe to investigate the efficacy, safety, and dose-response of nebulized RPL554 as a maintenance treatment for COPD. RPL554 is being dosed twice-daily and patients are required to withhold their regular long-acting bronchodilator therapy for the duration of the study. The primary endpoint of the study is improvement in lung function, as measured by forced expired volume in one second (FEV1), after dosing with RPL554 or placebo. The secondary endpoints are morning trough FEV1, COPD daily symptoms, dyspnea scale, and the St. George's Respiratory Questionnaire (SGRQ), a COPD specific quality of life scale.
"We are pleased to be making excellent progress in this important study as we have exceeded the 50 percent recruitment milestone and are enrolling ahead of schedule," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We are on track to complete enrollment faster than our original timeline, and are confident of now reporting top-line data in mid-2018, sooner than our previous guidance of second-half of 2018."
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the maintenance treatment of COPD patients and for the treatment of patients with cystic fibrosis.
In previous clinical trials, RPL554 has been observed to result in bronchodilatory effects when used alone or as an add-on treatment to other COPD bronchodilators. It has shown clinically meaningful and statistically significant improvements in lung function when administered in addition to frequently used short- and long-acting bronchodilators compared with such bronchodilators administered as a single agent. In addition, RPL554 has shown anti-inflammatory effects in a standard challenge study with COPD-like inflammation in human subjects. In these studies, RPL554 has been well tolerated.
Chronic obstructive pulmonary disease (COPD) is a progressive and life-threatening respiratory disease for which there is no cure.1 The condition damages the airways and the lungs, leading to persistent breathlessness, impacting a person's daily life and their ability to perform simple activities such as walking a short flight of stairs or carrying a suitcase.1 Although COPD is thought to be underdiagnosed, globally, around 384 million people suffer from the disease.1, This number, according to the World Health Organization (WHO), is likely to increase in coming years, with estimates that COPD will become the third leading cause of death worldwide by 2030.1, Current COPD therapies focus on reducing and controlling symptoms. Yet, despite the wide availability of these treatments, many patients continue to suffer acute periods of worsening symptoms known as exacerbations. These exacerbations often lead to emergency department visits or hospital admissions, and are also associated with high mortality.4 In the United States alone, the 2010 total annual medical costs related to COPD were estimated to be $32 billion, and are projected to rise to $49 billion in 2020.5
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, RPL554, is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that acts as both a bronchodilator and an anti-inflammatory agent in a single compound. In clinical trials, treatment with RPL554 has been observed to result in statistically significant improvements in lung function as compared to placebo, and has shown clinically meaningful and statistically significant improvements in lung function when administered in addition to frequently used short- and long-acting bronchodilators as compared to such bronchodilators administered as a single agent. Verona Pharma is developing RPL554 for the treatment of chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and potentially asthma.
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, statements regarding the design of the Phase 2b clinical trial of RPL554, the timing of availability of top-line data for the Phase 2b clinical trial, the importance of the Phase 2b clinical trial to our development plans for RPL554, the potential of RPL554 as a promising first-in-class treatment option for COPD, and the value of the data and insights that may be gathered from the Phase 2b clinical trial.
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 RPL554, 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 RPL554, 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 RPL554, which could adversely affect our ability to develop or commercialize RPL554; potential delays in enrolling patients, which could adversely affect our research and development efforts; we may not be successful in developing RPL554 for multiple indications; our ability to obtain approval for and commercialize RPL554 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 RPL554; and lawsuits related to patents covering RPL554 and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption "Risk Factors" in our final prospectus filed with the Securities and Exchange Commission ("SEC") on April 28, 2017 relating to our Registration Statement on Form F-1, 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.
For further information, please contact:
|Verona Pharma plc||Tel: +44 (0)20 3283 4200|
|Jan-Anders Karlsson, Chief Executive Officeremail@example.com|
| Stifel Nicolaus Europe Limited |
(Nominated Adviser and UK Broker)
| Tel: +44 (0) 20 7710 7600 |
|Stewart Wallace / Jonathan Senior / Ben Maddison|
|FTI Consulting (UK Media and Investor enquiries)||Tel: +44 (0)20 3727 1000|
|Simon Conway / Natalie Garland-Collinsfirstname.lastname@example.org|
|ICR, Inc. (US Media and Investor enquiries)|
|James Heins||Tel: +1 203-682-8251|
|Stephanie Carrington||Tel. +1 646-277-1282|
1 World Health Organization. Chronic Obstructive Pulmonary Disease. http://www.who.int/mediacentre/factsheets/fs315/en/. Accessed September 2017.
2 Adeloye D, Chua S, et al. Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health 2015; 5(2): 020415.
3 World Health Organization. Burden of COPD. http://www.who.int/respiratory/copd/burden/en/. Accessed September 2017.
4 COPD Foundations. Characteristics of COPD Patients Using United States Emergency Care or Hospitalization. https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization. Accessed September 2017.
5 Center for Disease Control. Increase Expected in Medical Costs for COPD. https://www.cdc.gov/features/ds-copd-costs/. Accessed September 2017.
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