Verona Pharma plc Verona Pharma Initiates Phase 2 Clinical Trial With Metered Dose Inhaler Formulation Of Ensifentrine For Ma...

 
TIDMVRP 
 
 
   Ensifentrine delivery via MDI inhalers could dramatically expand 
clinical utility and commercial opportunity 
 
   LONDON, June 04, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces the initiation of a Phase 2 dose-ranging 
trial to evaluate the pharmacokinetic ("PK") profile, efficacy and 
safety of a pressurized metered-dose inhaler ("MDI") formulation of 
ensifentrine (RPL554) in patients with moderate-to-severe chronic 
obstructive pulmonary disease ("COPD"). Verona Pharma is also developing 
a dry powder inhaler ("DPI") formulation of ensifentrine. 
 
   In the US, DPI/MDI handheld inhalers are the most widely used option for 
medication in COPD, where an estimated 5.5 million people use inhalers 
for COPD maintenance therapy.(1) This market was valued at approximately 
$6 billion in 2017.(2) 
 
   The Phase 2 trial using the MDI formulation has a randomized, 
double-blind, placebo-controlled, two-part design. The Company 
anticipates reporting data from the first part of the trial in the 
second half of 2019, with final data expected in the first quarter of 
2020. 
 
   The first part of the trial will evaluate the PK profile following a 
single dose of ensifentrine over 5 dose cohorts (100 ug, 300 ug, 1000 ug, 
3000 ug, 6000 ug) or placebo. Verona Pharma is aiming to enroll 36 
patients with moderate-to-severe COPD at two sites in the UK. The safety, 
tolerability and the bronchodilation effect of ensifentrine will also be 
assessed. 
 
   The second part of the trial will be conducted as a multiple dose 
crossover trial. Patients will be randomized to up to 4 dose levels or 
placebo, with the ensifentrine MDI formulation dosed twice-daily over 
one week. All patients will receive each of the dose levels and placebo, 
over the seven-day treatment period. The primary endpoint is based on 
bronchodilation and will be assessed in terms of peak forced expiratory 
volume in one second (FEV(1) ), a standard measure of lung function. 
Secondary objectives of this part of the trial include evaluating the 
safety, tolerability and the bronchodilator profile as well as the PK 
profile. 
 
   "We are excited to expand the ensifentrine portfolio with the MDI 
formulation for the treatment of patients with COPD. DPI and MDI inhaler 
formulations have the potential to expand dramatically the clinical 
utility and commercial opportunity of ensifentrine in the treatment of 
COPD," said Jan-Anders Karlsson, PhD, CEO of Verona Pharma. "We plan to 
seek a strategic partner to develop and commercialize inhalers of 
ensifentrine to maximize the significant potential value from this 
opportunity." 
 
   In addition to advancing the MDI and DPI formulations of ensifentrine 
into Phase 2 clinical development, Verona Pharma has also developed a 
nebulized formulation of ensifentrine, which is currently being 
evaluated in a Phase 2b clinical trial in moderate-to-severe COPD 
patients designed to inform dose selection for Phase 3 trials planned 
for 2020. 
 
   (1) IQVIA Q4 2017 
 
   (2) Trends in COPD: Morbidity and Mortality, American Lung Association, 
2013, Make et al, Intl. Journal of COPD, 2012 
 
   About COPD 
 
   COPD is a progressive and life-threatening respiratory disease without a 
cure. The World Health Organization estimates that it will become the 
third leading cause of death worldwide by 2030. The condition damages 
the airways and the lungs, leading to debilitating breathlessness that 
has a devastating impact on performing basic daily activities such as 
getting out of bed, showering, eating and walking. 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. About 800,000 US COPD patients on dual/triple inhaled therapy 
(LAMA/LABA +/- ICS) remain uncontrolled, experiencing symptoms that 
impair quality of life. These patients urgently need better treatments. 
 
   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, ensifentrine (RPL554), is a first-in-class, 
inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that 
has been shown to act as both a bronchodilator and an anti-inflammatory 
agent in a single compound. Nebulized ensifentrine is currently in Phase 
2b clinical development for the maintenance treatment of COPD and is 
planned to enter Phase 3 trials for this indication in 2020. Verona 
Pharma plans a targeted US launch of the nebulized formulation, which is 
expected to benefit from a simplified Medicare Part B reimbursement 
process in the US. Verona Pharma may also develop ensifentrine for the 
treatment of cystic fibrosis and asthma. 
 
   Ensifentrine has shown significant and clinically meaningful 
improvements in both lung function and COPD symptoms, including 
breathlessness in prior Phase 2 clinical studies in patients with 
moderate-to-severe COPD. In addition, ensifentrine has further improved 
lung function and reduced lung volumes in 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 800 people to 
date. 
 
   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 the MDI formulation of ensifentrine, the 
timing of availability of data from the Phase 2 clinical trial, the 
development plans for ensifentrine, the timing of the end-of-phase 2 
meeting with the FDA and the planned Phase 3 trials of nebulized 
ensifentrine, the value of the COPD market, the potential of 
ensifentrine as a promising first-in-class treatment option for COPD and 
the availability of Medicare reimbursement. 
 
   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 Phase 2b trial; 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; 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 ensifentrine; and 
lawsuits related to patents covering ensifentrine 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 Securities and Exchange Commission ("SEC") 
on March 19, 2019, 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 Officer               info@veronapharma.com 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                                 Tel: +44 (0)20 3283 4200 
 (Nominated Adviser and UK Broker) 
 Aubrey Powell /Jen Boorer /Iqra Amin (Corporate Finance) 
 Mia Gardner (Corporate Broking) 
 
Optimum Strategic Communications                           Tel: +44 (0) 203 922 0891 
 (European Media and Investor enquiries)                    verona@optimumcomms.com 
Mary Clark, Anne Marieke Ezendam, Hollie Vile 
 
Westwicke, an ICR Company                                  Tel. +1 646-277-1282 
 (US Investor enquiries)                                    Stephanie.Carrington@icrinc.com 
Stephanie Carrington
(END) Dow Jones Newswires
June 04, 2019 02:00 ET (06:00 GMT)
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