Verona Pharma Provides Clinical Development Update
Accelerates top-line data readouts from ongoing clinical trials with RPL554 in COPD and CF
LONDON, Feb. 13, 2018 (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 updated projections, bringing forward the timing for top-line data readouts from its ongoing clinical trials in chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).
- Phase 2b clinical trial of nebulized RPL554 for COPD Maintenance Treatment: The Company anticipates reporting top-line data from its Phase 2b trial early in the second quarter of 2018 (previously mid-2018). The four-week, double-blind, placebo-controlled, parallel group Phase 2b study enrolled approximately 400 patients with moderate-to-severe COPD at a number of sites across Europe and is investigating the efficacy, safety, and dose-response of nebulized RPL554 as a maintenance treatment for COPD.
- Phase 2a pharmacokinetic (PK) and pharmacodynamic (PD) clinical trial of RPL554 for CF: The Company anticipates reporting top-line data from its Phase 2a trial in late first quarter of 2018 (previously first half of 2018). The double-blind, placebo-controlled, cross-over Phase 2a study is evaluating the PK and PD profile and tolerability of single nebulized dose of RPL554 in 10 patients with CF, as well as the effect on lung function in such patients.
"We are pleased to be making excellent progress in these important studies," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We have completed the clinical phase of both studies ahead of schedule and now look forward to reporting top-line data sooner than our previous guidance."
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 CF. In pre-clinical studies, RPL554 has been observed to stimulate the CF transmembrane conductance regulator, a protein whose mutation results in dysfunctional ion channels in epithelial cells, leading to CF. Based on available data, RPL554 has the potential to enhance mucociliary clearance (reduce phlegm in the airways), reduce airway obstruction and inhibit inflammation.
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 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; delays in analyzing our top-line data; 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||SNELVeronaPharma@stifel.com|
|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|