PDUFA Target Action Date of
Eight posters including two oral presentations support potential of ensifentrine,
an investigational, first-in-class, selective, dual inhibitor of PDE3 and PDE4
Ensifentrine is a novel selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. The investigational product is currently under review by the
The posters are based on pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, first reported by the Company on
Details of Verona Pharma’s posters and the symposia are listed below and linked to the ATS website.
Late-Breaking Mini Symposium: Ensifentrine Reduces Exacerbation Frequency and Delays Progression from Gold B to Gold E
Presenter:
Session: B14 – Late Breaking Abstracts: Science that will impact clinical care
Mini Symposium: Ensifentrine added on to LAMA Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects with Moderate-to-Severe COPD
Presenter: Mark Dransfield, MD,
Session: C95 – New clinical trial results in chronic lung disease
Poster: P624 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Reduced Moderate/Severe Exacerbation Rate and Risk in Subjects With COPD Regardless of Baseline Blood Eosinophils
Participant:
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging
Poster: P625 – Ensifentrine Added on to LABA/ICS Therapy Improved Lung Function and Reduced Exacerbations in Symptomatic Subjects With Moderate-to-Severe COPD
Presenter:
Session: B52 – Evidence for therapeutic strategies in COPD: from established to emerging
Poster: P704 – Improvements in Breathlessness, COPD Symptoms and Quality of Life Reported With Ensifentrine in a Pooled Analysis of the ENHANCE Trials
Presenter:
Session: A101 – Full metal jacket targeting COPD and chronic airways disease
Poster: P901 – Ensifentrine Added on to LAMA Therapy Improved COPD Symptoms and Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter:
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies
Poster: P909 – Ensifentrine, A Novel, Selective Inhibitor of PDE3 and PDE4, Improved Dyspnea in Subjects With Symptomatic, Moderate-to-Severe COPD Over 24 Weeks
Presenter:
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies
Poster: P911 – Ensifentrine Added on to LABA/ICS Therapy Reduced Dyspnea and Improved Quality of Life in Subjects With Symptomatic Moderate-to-Severe COPD
Presenter:
Session: A27 – Emerging treatments and therapeutic strategies in COPD: results of clinical trials and observational studies
About
For further information please contact:
US Tel: +1-833-417-0262 | |
IR@veronapharma.com | |
US Investor Enquiries | Tel: +1-212-600-1902 verona@argotpartners.com |
Ten International / US Media Enquiries | Tel: +1-312-523-5016 tbcverona@tenbridgecommunications.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, statements relating to the timing of the FDA’s potential approval of the NDA for ensifentrine by the PDUFA date of
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; 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, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, 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; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended
Source:
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