VRP Verona Pharma Plc

 
TIDMVRP 
 
 
   Top-line results expected in 2Q 2021 
 
   LONDON and RALEIGH, N.C., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Verona 
Pharma plc (Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage 
biopharmaceutical company focused on respiratory diseases, announces it 
has completed enrollment (n=45) in its pilot clinical study evaluating 
the efficacy and safety of ensifentrine delivered via pressurized 
metered-dose inhaler ("pMDI") formulation in U.S. patients hospitalized 
with COVID-19. 
 
   David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: 
"Completing enrollment of the pilot study in COVID-19 is an important 
milestone and we are on track to report top-line results in the second 
quarter of 2021. We are pleased vaccines are now approved for the 
prevention of COVID-19; however, a significant unmet need remains for 
effective treatments for symptomatic patients. We believe ensifentrine, 
with its novel mechanism of action, could help to improve COVID-19 
patient outcomes." 
 
   Ensifentrine is a first-in-class product candidate with both 
bronchodilator and anti-inflammatory activities in one compound. 
Clinical data from studies of ensifentrine in the treatment of other 
respiratory diseases have shown ensifentrine improved lung function, 
reduced inflammation in the lungs* and reduced symptoms of cough and 
sputum production. Ensifentrine has been well tolerated in clinical 
trials involving more than 1,300 people. 
 
   About the study 
 
   The randomized, double-blind, parallel group pilot study will evaluate 
the efficacy and safety of pMDI ensifentrine added on to standard of 
care treatment in patients with COVID-19 compared to standard of care 
plus placebo. 
 
 
   -- Patient Population: 45 hospitalized patients with COVID-19. Single center 
      study at University of Alabama at Birmingham. 
 
   -- Dose/Duration: Patients randomized to receive 2 mg of pMDI ensifentrine 
      or placebo, twice-daily for up to 29 days or until discharge if this 
      occurs before 29 days. The clinical status of all patients will be 
      evaluated daily until discharge and at Day 29 and Day 60. 
 
   -- Primary Endpoint: Proportion of patients recovered from COVID-19 and no 
      longer hospitalized at Day 29. 
 
 
   -- Secondary Endpoints: Safety and tolerability, time to recovery, duration 
      of hospitalization, improvements in clinical status, supplemental oxygen 
      use, proportion of patients requiring mechanical ventilation and 
      mortality. 
 
 
   Further information about this study can be found at 
www.clinicaltrials.gov, NCT04527471. 
 
   *Franciosi LG, et al., Lancet Respir Med 2013 
 
   For further information, please contact: 
 
 
 
 
 
  Verona Pharma plc                                         Tel: +44 (0)20 3283 4200 
--------------------------------------------------------  --------------------------- 
  Victoria Stewart, Director of Communications              info@veronapharma.com 
--------------------------------------------------------  --------------------------- 
 
  Argot Partners                                            Tel: +1 212-600-1902 
   (US Investor Enquiries)                                   verona@argotpartners.com 
--------------------------------------------------------  --------------------------- 
  Kimberly Minarovich / Michael Barron 
--------------------------------------------------------  --------------------------- 
 
  Optimum Strategic Communications                          Tel: +44 (0)203 950 9144 
   (International Media and European Investor Enquiries)     verona@optimumcomms.com 
--------------------------------------------------------  --------------------------- 
  Mary Clark / Eva Haas / Shabnam Bashir 
--------------------------------------------------------  --------------------------- 
 
 
   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 also 
activates the Cystic Fibrosis Transmembrane Conductance Regulator 
("CFTR"), which is beneficial in reducing mucous viscosity and improving 
mucociliary clearance. Ensifentrine's mechanism of action has the 
potential to alleviate respiratory symptoms such as breathlessness and 
cough and work against inflammation associated with COPD or inflammation 
triggered by viruses. 
 
   Ensifentrine has demonstrated significant and clinically meaningful 
improvements in both lung function and symptoms, including 
breathlessness, in Verona Pharma's Phase 2 clinical studies in patients 
with moderate to severe Chronic Obstructive Pulmonary Disease ("COPD"). 
In addition, nebulized ensifentrine showed further improved lung 
function and reduced lung volumes in COPD 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 subjects 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. The Company is evaluating 
nebulized ensifentrine in its Phase 3 clinical program ENHANCE 
("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") 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. Two 
additional formulations of ensifentrine are currently in Phase 2 
development for the treatment of COPD: dry powder inhaler ("DPI") and 
pressurized metered-dose inhaler ("pMDI"). Ensifentrine is being 
evaluated in a pilot clinical study in patients hospitalized with 
COVID-19 and has potential applications in 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, the development of ensifentrine and the 
progress and timing of clinical trials and data, the goals and design of 
clinical trials, the potential for ensifentrine to be a first-in-class 
phosphodiesterase 3 and 4 inhibitor and to be the first therapy for the 
treatment of respiratory diseases to combine bronchodilator and 
anti-inflammatory effects in one compound, the potential of ensifentrine 
to significantly benefit patients with COVID-19 and to be safe and well 
tolerated in those patients, the potential of ensifentrine to alleviate 
respiratory symptoms such as breathlessness and cough and work against 
inflammation triggered by viruses, the sufficiency of funds to supports 
its operations and Phase 3 clinical program into 2023, and the potential 
of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and 
other respiratory diseases. 
 
   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 clinical trials; 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; our future growth and ability to compete depends on retaining 
our key personnel and recruiting additional qualified personnel; 
material differences between our "top-line" data and final data; our 
reliance on third parties, including clinical research organizations, 
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; and our vulnerability to natural disasters, global 
economic factors and other unexpected events, including health epidemics 
or pandemics like the novel coronavirus (COVID-19). These and other 
important factors under the caption "Risk Factors" in our Registration 
Statement on Form F-1 filed with the SEC on August 17, 2020, our Report 

on Form 6-K filed with the SEC on November 24, 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. 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. 
 
 
 
 

(END) Dow Jones Newswires

January 14, 2021 02:00 ET (07:00 GMT)

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