11:15 Mon 20 May 2019
Verona Pharma Presents Expanded Analysis of Ensifentrine Clinical Data in COPD Maintenance Treatment
Analysis confirms continued symptom benefits improving over time, supporting anti-inflammatory effects of ensifentrine in addition to bronchodilation
The expanded analysis is supportive of the differentiated, dual mechanism of action of ensifentrine, as both a bronchodilator and an anti-inflammatory agent in a single compound. It provides further evidence of the potential for ensifentrine to provide significant symptom benefits to patients.
“These encouraging data suggest that ensifentrine’s dual mode of action combining anti-inflammatory and bronchodilator effects will lead to additional symptom benefits in COPD patients,” said
Details of the expanded analysis are available on Verona Pharma’s website here.
Details of the abstract were provided in the announcement dated
https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A3846
Ensifentrine is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that has been shown in several previous clinical studies to act both as a bronchodilator and an anti-inflammatory agent in a single compound. It is currently being evaluated in a further Phase 2b clinical trial as an add-on to standard therapy for the maintenance treatment of COPD, with data anticipated around year-end and expected to inform dose selection for Phase 3 trials.
In addition to advancing the nebulized formulation,
About COPD
COPD is a progressive and life-threatening respiratory disease without a cure. The
About
In Phase 2 clinical studies in patients with moderate to severe COPD, ensifentrine has shown significant and clinically meaningful improvements in both lung function and COPD symptoms, including breathlessness. In addition, 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 regarding the value of trial results presented at ATS, ensifentrine as a new complementary treatment for patients with COPD, statements that there is an opportunity for additional symptom improvement via ensifentrine’s novel mechanism of action, the expectation that our Phase 2b study will inform the dose selection for Phase 3, the expected timelines for trial data, the end-of-Phase 2 FDA meeting and initiation of Phase 3, the future clinical development and positioning of ensifentrine, and the projected annual 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; 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 | |
info@veronapharma.com | |
N+1 Singer | Tel: +44 (0)20 3283 4200 |
(Nominated Adviser and | |
(European Media and Investor enquiries) | |
Mary Clark, | Tel: +44 (0) 203 922 0891 verona@optimumcomms.com |
Westwicke, an (US Media and Investor enquiries) | |
Tel: +1 203-919-7905 darcie.robinson@icrinc.com | |
Tel. +1 646-277-1282 stephanie.carrington@icrinc.com |
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