Verona Pharma Initiates Phase 2 Clinical Trial Evaluating Nebulized RPL554 as Add-on to Dual Bronchodilator Therapy for COPD Maintenance Treatment
This three-way crossover study will inform design of pivotal Phase 3 trials
Top line data expected first quarter 2019
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have bronchodilator as well as anti-inflammatory properties, and is currently in development for the maintenance treatment of COPD and for the treatment of cystic fibrosis (“CF”).
The randomized, double-blind, three-way crossover trial, being conducted at sites in the U.S. and in the
“We have already demonstrated that RPL554 is an effective add-on treatment to short- and long-acting bronchodilators in COPD patients. This Phase 2 trial will now examine the effect of RPL554 as an add-on to LAMA/LABA therapy, and in some patients to triple therapy, as many of these COPD patients continue to experience breathing difficulties and daily symptoms that impair their quality of life despite concomitant treatment with two bronchodilators. We believe the bronchodilator and anti-inflammatory properties of RPL554 may be particularly useful in this large group of patients with high, unmet medical need. This phase 2 trial is intended to provide important data to inform the design of pivotal Phase 3 studies with RPL554, expected to commence later next year,” said
About COPD
Chronic obstructive pulmonary disease (“COPD”) is a progressive and life-threatening respiratory disease for which there is no cure.1 Although COPD is thought to be underdiagnosed, globally, around 384 million people suffer from the disease.2 This number, according to the
About
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, including, but not limited to, statements regarding the design of the Phase 2 clinical trial of RPL554, the timing of availability of top-line data for the Phase 2 clinical trial, the importance of the Phase 2 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 2 clinical trial, including for the purpose of designing pivotal Phase 3 trials.
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 and the completion of our Phase 2 trial; we may not be successful in developing RPL554 for multiple indications; our ability to obtain regulatory approvals necessary to conduct later stage trials and to 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 Annual Report on Form 20-F filed with the
For further information, please contact:
Verona Pharma plc | Tel: +44 (0)20 3283 4200 |
Jan-Anders Karlsson, Chief Executive Officer | info@veronapharma.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-Collins | veronapharma@fticonsulting.com |
ICR, Inc. (US Media and Investor enquiries) | |
James Heins | Tel: +1 203-682-8251 James.Heins@icrinc.com |
Stephanie Carrington | Tel. +1 646-277-1282 Stephanie.Carrington@icrinc.com |
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2 Adeloye D, Chua S, et al. Global and regional estimates of COPD prevalence: Systematic review and meta–analysis.
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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
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6 Mullerova H., et al., Characterization of COPD Patients Treated With Inhaled Triple Therapy Containing Inhaled Corticosteroid [ICS], Long-Acting Beta2-Agonists [LABA], and Long-Acting Muscarinic Antagonists [LAMA] in the
6 Vestbo J, et al., Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINTY); a double-blind, parallel group, randomised controlled trial, The Lancet, Vol 389, p. 1919-1929;
Source: Verona Pharma plc