Verona Pharma to Present Additional Analyses of Phase 3 ENHANCE Studies in COPD at ERS International Congress 2024

Rhea-AI Summary

Verona Pharma (Nasdaq: VRNA) announces presentations of additional analyses from its Phase 3 ENHANCE studies on Ohtuvayre™ (ensifentrine) for COPD treatment at the ERS International Congress 2024. The presentations include one oral and three posters, highlighting Ohtuvayre's efficacy and safety in various COPD patient subgroups.

Ohtuvayre, a first-in-class dual inhibitor of PDE3 and PDE4, combines bronchodilator and anti-inflammatory effects. Key findings include improvements in lung function, reduced exacerbation rates, and enhanced quality of life across different patient populations. The analyses support Ohtuvayre's potential to benefit a broad range of COPD patients, marking the first novel inhaled mechanism for COPD maintenance treatment in over 20 years.

Positive

• Ohtuvayre demonstrated statistically significant and clinically meaningful improvements in lung function in Phase 3 ENHANCE trials
• Ohtuvayre reduced moderate/severe exacerbation rates in COPD patients
• Analyses show Ohtuvayre's efficacy across various COPD patient subgroups
• Ohtuvayre improved COPD symptoms and quality of life in pooled analysis of ENHANCE trials
• First novel inhaled mechanism for COPD maintenance treatment in over 20 years

Negative

• None.

One oral presentation and three posters support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4

LONDON and RALEIGH, N.C., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces one oral presentation and 3 posters on additional analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at the European Respiratory Society (“ERS”) International Congress 2024. The abstracts are available to conference participants on the ERS website and will be published in an upcoming issue of the peer reviewed publication, European Respiratory Journal.

Ohtuvayre (ensifentrine) is a first-in-class 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 therapy is the first novel inhaled mechanism for the maintenance treatment of COPD in more than 20 years.

The analyses will summarize the efficacy and safety of Ohtuvayre in the subgroup of patients, including reduction in the rate of exacerbation, with or without chronic bronchitis and in European patients. Additionally, a pooled analysis of patient reported outcomes and the effect of Ohtuvayre on reducing cough and sputum will also be presented.

“These analyses provide further support for Ohtuvayre’s potential to benefit a broad population of patients with COPD,” said Jadwiga Wedzicha, MD, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK. “The non-steroidal anti-inflammatory effects with this novel therapy are particularly beneficial and I am very excited about the impact of Ohtuvayre on COPD.”

Details of Verona Pharma’s presentations and posters are listed below and linked to the ERS website:

Oral presentation 2780: Ensifentrine improved lung function and reduced moderate/severe exacerbation rate and risk in patients with COPD regardless of chronic bronchitis history
Participant: Jadwiga Wedzicha, MD, Professor of Respiratory Medicine at the National Heart and Lung Institute, Imperial College London, UK
Session 265: Airway diseases therapeutics: novel research studies

Poster 2991: Ensifentrine treatment improves COPD symptoms and quality of life in a pooled analysis of the ENHANCE trials
Participant: Alexander Mathioudakis, MD, NIHR Clinical Lecturer in Respiratory Medicine, University of Manchester, UK
Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management

Poster 2995: Efficacy and safety of ensifentrine in European patients with moderate to severe COPD: pooled results from the ENHANCE trials
Participant: Frits M.E. Franssen, MD, Head of the Department of Respiratory Medicine, Maastricht University Medical Center, The Netherlands
Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management

Poster 2997: Ensifentrine improved symptoms and reduced moderate/severe exacerbation rate and risk in patients with COPD and significant cough and sputum
Participant: Victor Kim, MD, Professor, Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, US
Session 300: New frontiers in chronic obstructive pulmonary disease treatment and management

For further information please contact:

Verona Pharma plc	Tel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and Communications	IR@veronapharma.com
Argot Partners (US Investor Enquiries)	Tel: +1-212-600-1902 verona@argotpartners.com
Ten Bridge Communications International / US Media Enquiries	Tel: +1-312-523-5016 tbcverona@tenbridgecommunications.com
Leslie Humbel

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD.

About Verona Pharma

Verona Pharma is a biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical needs. Ohtuvayre (ensifentrine) is the Company’s first commercial product and the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine has potential applications in non-cystic fibrosis bronchiectasis, 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 within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements. Words such as “anticipate,” “believe,” “plan,” “expect,” “intend,” “may,” “potential,” “prepare,” “possible” and similar words and expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the potential benefits and efficacy of our drug Ohtuvayre and future poster presentations and academic publications pertaining to Ohtuvayre.

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 efficacy of Ohtuvayre compared to competing drugs and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) on August 8, 2024, as such factors may be updated from time to time in our other filings with the SEC. We disclaim any obligation to update or revise any forward-looking statement contained in this press release, even if subsequent events cause our views to change, except as required under applicable law.

FAQ

What is Ohtuvayre (ensifentrine) and how does it work for COPD?

Ohtuvayre (ensifentrine) is a first-in-class dual inhibitor of PDE3 and PDE4 enzymes for COPD treatment. It combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule, offering a novel approach to COPD maintenance therapy.

What were the key findings from Verona Pharma's Phase 3 ENHANCE studies on Ohtuvayre (VRNA)?

The Phase 3 ENHANCE studies showed that Ohtuvayre significantly improved lung function, reduced moderate/severe exacerbation rates, and enhanced quality of life in COPD patients. These benefits were observed across various patient subgroups, including those with or without chronic bronchitis.

When and where will Verona Pharma present the ENHANCE study results for Ohtuvayre?

Verona Pharma will present additional analyses from the ENHANCE studies at the European Respiratory Society (ERS) International Congress 2024. The presentations include one oral presentation and three posters highlighting Ohtuvayre's efficacy and safety in COPD treatment.

How does Ohtuvayre (VRNA) differ from existing COPD treatments?

Ohtuvayre is the first novel inhaled mechanism for COPD maintenance treatment in over 20 years. It uniquely combines bronchodilator and anti-inflammatory effects in one molecule, potentially offering broader benefits compared to existing therapies.