Verona Pharma plc Verona Pharma Initiates Pilot Study With Pmdi Ensifentrine In U.S. Patients Hospitalized With Covid-19

 
TIDMVRP 
 
   LONDON and RALEIGH, N.C., Sept. 08, 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 a pilot study to investigate the efficacy and safety of 
ensifentrine delivered via pressurized metered-dose inhaler ("pMDI") 
formulation in U.S. patients hospitalized with COVID-19. 
 
   The study will evaluate the effect of ensifentrine on key outcomes in 
patients hospitalized with COVID-19 including facilitation of recovery 
from the viral infection, clinical status improvement and reduction in 
supplemental oxygen use and progression to mechanical ventilation. 
 
   Ensifentrine is a first-in-class product candidate that combines 
bronchodilator and anti-inflammatory activities in one compound. 
Clinical data from studies of ensifentrine in the treatment of other 
respiratory diseases have shown that ensifentrine improved oxygenation, 
reduced inflammation in the lungs and enhanced mucus clearance*. 
Ensifentrine has been well tolerated in clinical trials involving more 
than 1,300 people to date. 
 
   Mike Wells, MD, MSPH, a pulmonologist and Principal Investigator at the 
University of Alabama at Birmingham, commented: "Therapies are urgently 
needed to treat patients hospitalized with COVID-19. Ensifentrine has 
demonstrated impressive effects on improving lung function and symptoms 
in patients with obstructive lung diseases, along with notable 
anti-inflammatory effects following inhaled dosing in clinical trials to 
date. Combined with positive safety results, ensifentrine has the 
potential to significantly benefit patients suffering from COVID-19." 
 
   David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: 
"The need for effective COVID-19 treatments to reduce the disease burden 
is clear and we believe ensifentrine, with its novel mechanism of action, 
could help to improve patient outcomes. If the pilot study is successful, 
we are committed to progressing ensifentrine as a treatment for COVID-19 
and, if approved, increasing supplies to meet public health needs." 
 
   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: Approximately 45 hospitalized patients   with 
      COVID-19. Single center study at University of Alabama at Birmingham. 
 
   -- Dose/Duration: Patients will be 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 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, improvements in clinical 
      status, time to recovery, supplemental oxygen use, proportion of patients 
      requiring mechanical ventilation and mortality. 
 
 
   Further information about this study can be found at 
https://www.globenewswire.com/Tracker?data=-97K3Hvv-MOr0zYN8XtSA-CRZ5VJofV6gWnLOZbze9MeWtxbdWUgsfMWZea-FbDc5S2WoOraZa2CS9bfgi2soTxnhsMikpb6XdorYElVwFE= 
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 
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 
 (U.S. Investor Enquiries)                     verona@argotpartners.com 
Kimberly Minarovich / Michael Barron 
 
 
   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 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 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. 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. 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 also 
has potential applications in COVID-19, cystic fibrosis, asthma and 
other respiratory diseases. For more information, please visit 
https://www.globenewswire.com/Tracker?data=i-8nciGbGPFWbJ0e8032AvjevyW5oXgfaqJt3BiUHt7jJZCPR8XhYu5U2ZODnZZQCjt4f0K7VZglcQhNFx8Sa1apSybCi9DelmNTrBEhvhIjIkunwNLWLBIqbLRhOse7dd9fgAm_XhmVtnkRWEbmffM10RjLKRHSOrMIuPWuYbaUqSq5W6KwRoBUfcUb48TM6hCS0kx9RHpM4TrxJyymgXvckO-qVgegEGh0abr8Vh7dn_HvyTlmE_0ele8XGhN0jzjv19ao9-LpZjvCI4lwzQ== 
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, the 
progress and timing of initiation of clinical trials, the goals and 
design of clinical trials, patient enrolment and study completion, 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 ability of the Company to progress the 
development of ensifentrine and to secure supplies of the drug for 
ongoing development and commercialization, 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 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. 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

September 08, 2020 02:00 ET (06:00 GMT)

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