Verona Pharma plc Verona Pharma Reports Positive Phase 2 Results With Dry Powder Inhaler Formulation Of Ensifentrine In Copd

 
TIDMVRP 
 
   LONDON, Aug. 05, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) 
(Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical company focused on 
respiratory diseases, announces positive Phase 2 data with a dry powder 
inhaler ("DPI") formulation of its lead development product, 
ensifentrine, for the maintenance treatment of chronic obstructive 
pulmonary disease ("COPD"). All of the primary and secondary lung 
function endpoints were met in the Phase 2 trial. 
 
   Highlights: 
 
 
   -- Primary endpoint met: highly statistically significant and clinically 
      meaningful dose-dependent improvement in lung function 
 
   -- Secondary lung function endpoints met, data supportive of twice daily 
      dosing and ensifentrine well tolerated at all dose levels 
 
   -- Delivery via DPI could substantially expand the clinical utility and 
      commercial opportunity for ensifentrine in COPD 
 
   -- Conference call and webcast to be held tomorrow (Tuesday, August 6) at 8 
      am EDT / 1 pm BST to discuss the Company's second quarter financial 
      results and the study data 
 
 
   The Phase 2 trial met all of its primary and secondary lung function 
endpoints with ensifentrine delivered in a DPI format. The magnitude of 
improvement in lung function and duration of action were highly 
statistically significant and support twice daily dosing of ensifentrine 
for the treatment of COPD. 
 
 
   -- Primary endpoint met: peak FEV11 corrected for placebo showed 
      improvements over baseline of 102 mL for the 150 ug2 dose, 175 mL for the 
      500 ug dose, 180 mL for the 1500 ug dose and 260 mL for the 3000 ug dose, 
      (p<0.0001 for all doses), all highly statistically significant. 
 
   -- Secondary endpoints met:--  Statistically significant improvements in 
      average FEV1 over 12 hours were observed over 7 days with all doses 
      (average FEV1 AUC(0-12hr)3 corrected for placebo: 36 mL for the 150 ug 
      dose, 90 mL for the 500 ug dose, 80 mL for the 1500 ug dose and 147 mL 
      for the 3000 ug dose; p<0.05 for all doses).--  Ensifentrine in a 
      handheld dry powder format was well tolerated at all doses with an 
      adverse event profile similar to placebo. The safety profile was 
      comparable to that observed in prior studies with nebulized ensifentrine. 
 
 
   "Achieving a bronchodilator response of this magnitude in COPD patients 
is clinically meaningful and very encouraging," commented Joseph A 
Boscia, III, MD a Pulmonary Physician and Principle Investigator at 
Vitalink Research-Union, South Carolina. "This highlights the potential 
for ensifentrine's unique mechanism of action to provide lung function 
improvement and meet the urgent clinical need for new treatments for 
patients with this progressive and debilitating disease." 
 
   Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said: "These very 
promising data with the DPI formulation support our view that 
ensifentrine is an effective bronchodilator in COPD patients, whether 
administered as a dry powder via a handheld inhaler or as a suspension 
via a nebulizer. Our proof-of-concept dry powder formulation can be 
adapted to different DPI devices used in the market. Millions of 
patients prefer to use a handheld device, and these data significantly 
expand ensifentrine's commercial potential. We plan to complete further 
development and commercialization of the DPI formulation with a partner 
and these clinical data strongly support this opportunity." 
 
   In addition to the DPI formulation of ensifentrine, Verona Pharma is 
developing a pressurized metered-dose inhaler ("pMDI") formulation of 
ensifentrine and expects to report initial single dose data using this 
widely used handheld inhaler format in the second half of 2019, with 
final multiple dose data from a one week study expected in the first 
quarter of 2020. Progression of the nebulized suspension formulation of 
ensifentrine continues, with data from the ongoing Phase 2b clinical 
trial expected around year end. Verona Pharma anticipates progressing 
the ensifentrine nebulizer formulation into Phase 3 clinical trials in 
2020. 
 
   Study Design 
 
   The randomized, double-blind, placebo-controlled, two-part Phase 2 trial 
(ClinicalTrial.gov NCT04027439) enrolled 35 patients with 
moderate-to-severe COPD at one US site to investigate the efficacy and 
safety of a DPI formulation of ensifentrine compared to placebo. In Part 
A of the trial, patients received a single dose of one (out of five) 
dosage strengths of ensifentrine (150 ug, 500 ug, 1500 ug, 3000 ug, or 
6000 ug) or placebo. In March 2019, Verona Pharma reported positive 
interim efficacy and safety data from the first part of the trial, 
triggering initiation of the second part of the trial. 
 
   In Part B of the trial, patients were randomized to receive one of four 
dose levels (150 ug, 500 ug, 1500 ug, or 3000 ug) of ensifentrine DPI 
formulation or placebo, administered twice daily over one week. All 
patients received each dose level and placebo over five seven-day 
treatment periods. The primary endpoint was improvement in peak 
bronchodilator effect of repeat doses of ensifentrine delivered via DPI 
compared to placebo, as measured by FEV(1) . Secondary objectives 
included evaluating the safety, tolerability and bronchodilator profile 
of repeat doses of ensifentrine administered by DPI, as well as the 
pharmacokinetic profile, onset of action, and the amount of rescue 
medication use during treatment periods. 
 
   Data on the primary and secondary lung function and pharmacokinetic 
profile endpoints have been received and all endpoints were met. Data on 
the amount of rescue medication use during treatment periods are 
expected later this month. 
 
   Conference Call 
 
   Verona Pharma will host an investment community conference call tomorrow 
(Tuesday, August 6) at 8 am EDT / 1 pm BST to discuss the second quarter 
financial results and the study data. 
 
   Analysts and investors may participate in the conference call using the 
conference ID: 7433729 and dialing the following numbers: 
 
 
   -- 866-940-4574 or 409-216-0615 for callers in the United States 
 
   -- 0800 028 8438 for callers in the United Kingdom 
 
   -- 0800 181 5287 for callers in Germany 
 
 
   Those interested in listening to the conference call live via the 
internet may do so by visiting the "Events and Presentations" page on 
the "Investors" section of Verona Pharma's website at 
https://www.globenewswire.com/Tracker?data=uR7sG9eCL3AUVF4yNAT1PhQutrSNLjOi2gEpdcKfs8PLwEhqm2h9rri3eRe-TjnC9Lmi2EPpeAeWio2lxmenEWGWyuIrCe1jPpupDW2ntdrBwUdggFeUUO5iMDKjoteH80ixtMPZqbLQjj0Rm_Mk01rNjnu8MIbSOz1obHjTInoEMEFd3LNOGTPkfNmOr6PCVflNAxhRI2Tg886ZZ-Y8G6yU7VW6QvIiTbs-fUcPbtzvjRxdXXh4ZSxy6BS3oCTMwKU2hg-DDx4_uYyPkd1rr11X75_1tAkVcZj4XerOMwFl1UZ9F7IbrljiCpy1udjEBDfYFvnY3JVbnTWphaQ6t1wl53KdhpYu_agIa96ZtcEzwShiWFqNVtj0pBjJ2fHBj4yS-v6DbdiUfuuiFxuPASuyDUmeJKtk70mKsgcZPVthQ4ynMtxMwQo8FhojhNawhvWKnUMeYNOSfpVO1Hv12Q== 
http://investors.veronapharma.com/events-and-presentations/events and 
clicking on the webcast link. Slides highlighting the top-line data will 
also be posted to the "Events and Presentations" page. 
 
   THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF 
ARTICLE 7 OF REGULATION (EU) NO 596/2014. 
 
   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. In the US, DPI and pMDI 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. This market was valued at 
approximately $6 billion in 2017. 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. Three formulations of ensifentrine are under 
development for the treatment of COPD: 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; a dry powder inhaler ("DPI") formulation reported positive Phase 2 
data in August 2019; a pressurized metered-dose inhaler ("pMDI") 
formulation expects to report Phase 2 single dose data in the second 
half of 2019, with final data expected in the first quarter of 2020. 
Verona Pharma may also develop ensifentrine for the treatment of cystic 
fibrosis and asthma. 
 
   Nebulized 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, nebulized 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 that ensifentrine is a 
first-in-class inhibitor, that inhaler formulations of ensifentrine 
could expand the clinical utility and commercial opportunity for 
ensifentrine, the plan to complete late stage development and 
commercialization of the DPI formulation with a partner and that the 
data supports this opportunity, the timing of Phase 3 trials of 
nebulized ensifentrine, the timing of receipt of data from clinical 
trials, the need for better treatment options for COPD, and projections 
regarding the mortality rate of, and medical costs related to, COPD. 
 
   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)20 950 9144 
 (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                               Stephanie.carrington@icrinc 
                                                   .com 
 
 
 
   __________________________ 
 
   (1) FEV(1) : forced expiratory volume in one second, a standard measure 
of lung function 
 
   (2) ug: microgram, or mcg 
 
   (3) FEV(1) AUC(0-12hr: area under the curve 0-12 hours calculated using 
the trapezoidal rule, divided by the observation time (12h) to report in 
mL, a measure of the aggregate effect over 12 hours

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August 05, 2019 02:00 ET (06:00 GMT)

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