Verona Pharma Reports Positive Phase 2 Results with Dry Powder Inhaler Formulation of Ensifentrine i
- 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 BSTto 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 µg2 dose, 175 mL for the 500 µg dose, 180 mL for the 1500 µg dose and 260 mL for the 3000 µg 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 µg dose, 90 mL for the 500 µg dose, 80 mL for the 1500 µg dose and 147 mL for the 3000 µg 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-
In addition to the DPI formulation of ensifentrine,
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 µg, 500 µg, 1500 µg, 3000 µg, or 6000 µg) or placebo. In
In Part B of the trial, patients were randomized to receive one of four dose levels (150 µg, 500 µg, 1500 µg, or 3000 µg) 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 FEV1. 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.
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
- 0800 181 5287 for callers in
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 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.
COPD is a progressive and life-threatening respiratory disease without a cure. The
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.
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
For further information, please contact:
|Tel: +44 (0)20 3283 4200|
|N+1 Singer |
(Nominated Adviser and
|Tel: +44 (0)20 3283 4200|
(European Media and Investor Enquiries)
|Tel: +44 (0)20 950 9144 |
|Mary Clark / |
|Westwicke, an |
(US Investor enquiries)
|Tel: +1 646-277-1282|
1 FEV1: forced expiratory volume in one second, a standard measure of lung function
2 µg: microgram, or mcg
3 FEV1 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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