VRP Verona Pharma Plc

 
TIDMVRP 
 
 
   LONDON and RALEIGH, N.C., Feb. 02, 2021 (GLOBE NEWSWIRE) -- In a release 
issued under the same headline earlier today by Verona Pharma plc 
(Nasdaq: VRNA), please note that all instances of the unit "ug" were 
mistakenly represented as "mg." The corrected release follows: 
 
   Primary and secondary lung function endpoints met 
 
   Results support twice-daily dosing 
 
   Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma"), a clinical-stage 
biopharmaceutical company focused on respiratory diseases, announces 
positive Phase 2 data with a pressurized metered-dose inhaler ("pMDI") 
formulation of ensifentrine in patients with moderate to severe chronic 
obstructive pulmonary disease ("COPD"). 
 
   Ensifentrine delivered by pMDI met all of the primary and secondary lung 
function endpoints in the 7 day, Phase 2 clinical trial. The magnitude 
of improvement in lung function was dose-ordered and highly 
statistically significant at peak and over the 12-hour dosing interval 
compared with placebo, and supports twice-daily dosing of ensifentrine 
via pMDI for the treatment of COPD. 
 
   Highlights 
 
 
   -- Primary endpoint met at all doses: highly statistically significant and 
      clinically meaningful increase in lung function as measured by peak 
      forced expiratory volume in one second ("FEV1")1 measured over 4 hours 
      post-dose, compared to placebo after 7 days of treatment. Improvements in 
      peak FEV1 corrected for placebo were 205 mL (p<0.0001) for the 300 ug 
      dose, 277 mL (p<0.0001) for the 1000 ug dose, and 326 mL (p<0.0001) for 
      the 3000 ug dose. 
 
   -- Secondary lung function endpoints met: results support twice-daily 
      dosing.Statistically significant improvements in average FEV1 over 12 
      hours corrected for placebo (average FEV1 AUC (0-12hr)2) were 120 mL 
      (p=0.0018) for the 300 ug dose, 187 mL (p<0.0001) for the 1000 ug dose, 
      and 197 mL (p<0.0001) for the 3000 ug dose.Statistically significant 
      improvements in morning trough FEV1 corrected for placebo were 46 mL (not 
      significant) for the 300 ug dose, 80 mL (p=0.0115) for the 1000 ug dose, 
      and 110 mL (p=0.0066) for the 3000 ug dose.Statistically significant 
      improvements in average FEV1 over 4 hours corrected for placebo (average 
      FEV1 AUC (0-4hr)2) were 178 mL (p<0.0001) for the 300 ug dose, 256 mL 
      (p<0.0001) for the 1000 ug dose, and 301 mL (p<0.0001) for the 3000 ug 
      dose. 
 
 
   -- Ensifentrine pMDI formulation was well tolerated at each dose with an 
      adverse event profile similar to placebo. 
 
   "Demonstrating this magnitude of improvement in lung function is 
exciting," said Dave Singh, M.D., Professor of Clinical Pharmacology and 
Respiratory Medicine, Medicines Evaluation Unit, University of 
Manchester, and Investigator in the study. "Combined with ensifentrine's 
unique dual mechanism of action and favorable efficacy and safety 
profile already demonstrated in multiple Phase 2 clinical trials via 
nebulizer and dry powder inhaler ("DPI"), these data strengthen its 
potential as a novel therapeutic for COPD." 
 
   David Zaccardelli, Pharm. D., President and CEO of Verona Pharma, said: 
"We are very encouraged by these compelling data, which are consistent 
with results from Phase 2 clinical trials with our nebulized and DPI 
formulations of ensifentrine. All three inhaled formulations have 
demonstrated significant improvements in lung function in COPD patients, 
supporting the broad utility of ensifentrine delivered via nebulizers 
and handheld inhalers. 
 
   The development of pMDI and DPI formulations of ensifentrine provides 
expanded opportunities including life cycle management, new indications 
and partnering." 
 
   Study Design 
 
   The randomized, double-blind, two-part Phase 2 trial evaluated the 
pharmacokinetics, efficacy and safety of pMDI ensifentrine for the 
treatment of moderate to severe COPD after a single dose and repeat 
doses over 7 days. Part A of the study evaluated the pharmacokinetic 
profile, safety and efficacy following a single dose of ensifentrine 
over 5 dose levels in a parallel group design. In Part B, patients who 
completed Part A were randomized to receive 3 doses of ensifentrine (300 
ug, 1000 ug, or 3000 ug) or placebo twice-daily over 7 days in a 
complete block crossover design. 
 
   Single Dose Trial, Part A 
 
 
   -- Patient Population: 40 moderate to severe COPD patients at two sites in 
      the UK. 
 
   -- Dose/Duration: Patients were randomized to receive a single dose out of 
      five dose levels (100 ug, 300 ug, 1000 ug, 3000 ug, 6000 ug) of pMDI 
      ensifentrine or placebo. 
 
 
   Multiple Dose Crossover Trial, Part B 
 
 
   -- Patient Population: 28 moderate to severe COPD patients who participated 
      in Part A continued to Part B at two sites in the UK. 
 
   -- Dose/Duration: Patients were randomized to receive 3 dose levels (300 ug, 
      1000 ug, 3000 ug) of pMDI ensifentrine or placebo, twice-daily over 7 
      days. All patients were to receive each of the dose levels and placebo 
      over four 7-day treatment periods. 
 
 
   Endpoints 
 
 
   -- Primary Endpoint: Improvement in lung function as measured by peak 
      FEV1 over 4 hours post-dose 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. 
 
 
   Further information about this clinical trial can be found at 
ClinicalTrials.gov, NCT04091360 
https://www.globenewswire.com/Tracker?data=-jhpJSRe3luBcYyjXgvXHlskcelNDwxMCMUbnjH4RbC4XAlodXmeKZ-LmBw4gQZIY5-g_wRBlqmPXbY5k2AhJcJ6wGBggnLsNf003W7JhY6pskW2WxBh3fkvwt_y0uM-B86ryfRZhOV-GnoKUI2PxdpXT7aC-tN-Tlh0j5aUC1Q= 
. 
 
   (1) Peak FEV(1) : Peak Forced Expiratory Volume in one second, was 
measured as the highest FEV(1) value recorded over 4 hours post-dose. 
FEV(1) is a standard measure of lung function. 
 
   (2) FEV(1)  AUC(0-12hr) and FEV(1) AUC(0-(4) (hr) ): Area Under the 
Curve 0-12 hours and 0-4 hours calculated using the trapezoidal rule, 
divided by the observation time (12 hours or 4 hours) to report in mL, a 
measure of the aggregate effect over 12 hours or 4 hours. 
 
   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 broad utility of 
ensifentrine delivered via nebulizers and handheld inhalers, 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

February 02, 2021 06:17 ET (11:17 GMT)

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