VRP Verona Pharma Plc

 
TIDMVRP 
 
 
   Results expected in the first half of 2021 
 
   LONDON and RALEIGH, N.C., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Verona 
Pharma plc (AIM: VRP) (Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage 
biopharmaceutical company focused on respiratory diseases, announces the 
initiation of the second, multiple dose, part of a Phase 2 trial to 
evaluate the pressurized metered-dose inhaler ("pMDI") formulation of 
ensifentrine in patients with moderate to severe chronic obstructive 
pulmonary disease ("COPD"). Results from the study (Part B) are expected 
in the first half of 2021. 
 
   Positive efficacy and safety data from the first, single dose, part of 
the study (Part A) in 40 patients with moderate to severe COPD were 
announced by the Company on March 31, 2020 
https://www.globenewswire.com/Tracker?data=sDKbDNrG9kUnjAoVnJor6Z3srYpXy7asgij-Hcw-M41ZyaJF5b5k2TYxqa64Qwd-3bfPahcKTqFs8KAnZI7TpoL4u2FiQJ6FuGobExrjLQ1Qzrdo_9ozuXivmoJ6i56u6A7aXe19ZHCXl8eOWY1B4yPIraxX8QzHR843sLISipJ2iIX1LmbAqezcyOQbU1cb 
. The results demonstrated a statistically significant and clinically 
meaningful increase in lung function as measured by forced expiratory 
volume in one second ("FEV(1) ")(1) compared to placebo. Verona Pharma 
decided to postpone initiation of Part B of the study due to concerns 
for the safety of patients and study staff because of the COVID-19 
pandemic. Following an assessment of local infection rates and control 
measures in addition to procedures put in place by the UK clinical sites, 
the Company has now initiated Part B, which will evaluate the pMDI 
formulation. 
 
   Multiple Dose Crossover Trial, Part B 
 
 
   -- Patient Population: Approximately 30 moderate to severe COPD patients who 
      participated in Part A are planned to continue to Part B at two sites in 
      the UK. 
 
   -- Dose/Duration: Patients will be randomized to receive 3 dose levels (300 
      ug, 1000 ug, 3000 ug) of pMDI ensifentrine or placebo, twice-daily over 
      one week. All patients will receive each of the dose levels and placebo 
      over four 7-day treatment periods. 
 
   -- Primary Endpoint: Improvement in lung function as measured by peak FEV1 
      with ensifentrine compared to placebo after 7 days of treatment. 
 
   -- Secondary Endpoints: Safety and tolerability, other lung function 
      measures such as trough FEV1, average FEV1 over 4 and 12 hours, and 
      steady state pharmacokinetic profile of ensifentrine pMDI. 
 
 
   "We are pleased to start the multiple dose part of this pMDI study and 
expect the results in the first half of 2021," said David Zaccardelli, 
Pharm. D., President and CEO of Verona Pharma. "Data from the single 
dose part of this pMDI study are very encouraging and consistent with 
data from Phase 2 clinical trials with our nebulized and dry powder 
inhaler ("DPI") formulations of ensifentrine. 
 
   pMDI and DPI formulations are important delivery mechanisms in the 
approximately $9.6 billion US market for maintenance COPD therapies(2) . 
The development of pMDI and DPI formulations of ensifentrine provides 
expanded opportunities including life cycle management, new indications 
and partnering. We look forward to providing further updates on this 
pMDI study and our upcoming Phase 3 ENHANCE trials and pilot trial in 
hospitalized patients with COVID-19." 
 
   For further information on this clinical trial, please visit 
ClinicalTrials.gov, NCT04091360 
https://www.globenewswire.com/Tracker?data=-4wJMt1jAt0R81nQdWEc27XIBv8xtmWlxa976HJNqy1Hpl8xh3vYKFo-7WSEDJpGx6xf73dtYW-bF5qj1VzRLs1q2QPTtm4BwrNSHbFj7JtaiBugjPZ6xMt8vU_NQ9zlW94HTwgYGCfEZAg2dhvkQYAQCP7kpisnJg9yn5IIuo8uZ8WF251waWJIhLfolcSA 
. 
 
   (1) FEV(1) : Forced Expiratory Volume in one second, a standard measure 
of lung function 
 
   (2) IQVIA MIDAS, IQVIA MIDAS Medical 
 
   About Ensifentrine 
 
   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 has demonstrated 
significant and clinically meaningful improvements in both lung function 
and COPD symptoms, including breathlessness, in Verona Pharma's prior 
Phase 2 clinical studies in patients with moderate to severe COPD. In 
addition, nebulized ensifentrine showed 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 1,300 people to date. 
 
   About Verona Pharma 
 
   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. If 
successfully developed and approved, Verona Pharma's product candidate, 
ensifentrine, has the potential to be the first therapy for the 
treatment of respiratory diseases that combines bronchodilator and 
anti-inflammatory activities in one compound. Following a response from 
the U.S. FDA to Verona Pharma's End-of-Phase 2 briefing package, the 
Company plans to initiate its Phase 3 clinical program ENHANCE 
(Ensifentrine as a Novel inHAled Nebulized COPD thErapy) later in 2020 
for nebulized ensifentrine for COPD maintenance treatment. The Company 
raised gross proceeds of $200 million through a private placement in 
July 2020 and expects the funds to support its operations and Phase 3 
clinical program into 2023. Verona Pharma is currently in Phase 2 
development with two additional formulations of ensifentrine for the 
treatment of COPD: dry powder inhaler (DPI) and pressurized metered-dose 
inhaler. Ensifentrine also has potential applications in COVID-19, 
cystic fibrosis, asthma and other respiratory diseases. For more 
information, please visit www.veronapharma.com. 
 
   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 development and 
potential of ensifentrine, including its potential to treat patients 
with COPD and COVID-19, the initiation, progress and timing of clinical 
trials, our expectations surrounding clinical trial results, the market 
opportunity for various formulations of ensifentrine, including 
estimates of the US sales for maintenance COPD therapies, the impact of 
the COVID-19 pandemic on our business and operations and the Company's 
future financial results and the sufficiency of our cash and cash 
equivalents. 
 
   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; 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; the loss of any key 
personnel and our ability to recruit replacement personnel, as well as 
the impact of our management team transition; 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; lawsuits related to patents covering 
ensifentrine and the potential for our patents to be found invalid or 
unenforceable; the impact of the COVID-19 pandemic on our operations, 
the continuity of our business and general economic conditions; and our 
vulnerability to natural disasters, global economic factors and other 
unexpected events, including health epidemics or pandemics like 
COVID-19. 
 
   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 February 27, 2020, under the caption "Supplemental 
Risk Factor Disclosures" in our Report on Form 6-K filed with the SEC on 
April 30, 2020, under the caption "Risk Factors" in our Registration 
Statement on Form F-1 filed with the SEC on August 17, 2020, 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, operational review, outlook and financial review. 
Any such forward-looking statements represent management's estimates as 
of the date of this press release and operational and financial review. 
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, operational review, 
outlook and financial review. 
 
   For further information, please contact: 
 
 
 
 
Verona Pharma plc                                     Tel: +44 (0)20 3283 4200 
David Zaccardelli, Chief Executive Officer            info@veronapharma.com 
Victoria Stewart, Director of Communications 
 
N+1 Singer                                            Tel: +44 (0)20 7496 3000 
 (Nominated Adviser and UK Broker) 
Aubrey Powell / George Tzimas / Iqra Amin (Corporate 
 Finance) 
Tom Salvesen (Corporate Broking) 
 
Optimum Strategic Communications                      Tel: +44 (0)203 950 9144 
 (European Media and Investor Enquiries)               verona@optimumcomms.com 
Mary Clark / Eva Haas / Shabnam Bashir 
 
Argot Partners                                        Tel: +1 212-600-1902 
 (US Investor Enquiries)                               verona@argotpartners.com 
Kimberly Minarovich / Michael Barron 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

August 19, 2020 02:00 ET (06:00 GMT)

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