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

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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.

Verona Pharma (Nasdaq: VRNA) annuncia la presentazione di ulteriori analisi dei suoi studi di Fase 3 ENHANCE riguardanti Ohtuvayre™ (ensifentrine) per il trattamento della BPCO al ERS International Congress 2024. Le presentazioni includono un intervento orale e tre poster, evidenziando l'efficacia e la sicurezza di Ohtuvayre in vari sottogruppi di pazienti affetti da BPCO.

Ohtuvayre, un inibitore duale di prima classe di PDE3 e PDE4, combina effetti broncodilatatori e antinfiammatori. I risultati chiave includono miglioramenti nella funzione polmonare, tassi di riacutizzazione ridotti e un aumento della qualità della vita tra diverse popolazioni di pazienti. Le analisi supportano il potenziale di Ohtuvayre di beneficiare un'ampia gamma di pazienti affetti da BPCO, segnando il primo nuovo meccanismo inalato per il trattamento di mantenimento della BPCO in oltre 20 anni.

Verona Pharma (Nasdaq: VRNA) anuncia presentaciones de análisis adicionales de sus estudios de Fase 3 ENHANCE sobre Ohtuvayre™ (ensifentrine) para el tratamiento de la EPOC en el ERS International Congress 2024. Las presentaciones incluyen una charla oral y tres pósteres, destacando la eficacia y seguridad de Ohtuvayre en varios subgrupos de pacientes con EPOC.

Ohtuvayre, un inhibidor dual de primera clase de PDE3 y PDE4, combina efectos broncodilatadores y antiinflamatorios. Los hallazgos clave incluyen mejoras en la función pulmonar, tasas de exacerbación reducidas y una mejor calidad de vida en diferentes poblaciones de pacientes. Los análisis respaldan el potencial de Ohtuvayre para beneficiar a un amplio rango de pacientes con EPOC, marcando el primer nuevo mecanismo inhalado para el tratamiento de mantenimiento de la EPOC en más de 20 años.

Verona Pharma (Nasdaq: VRNA)는 Ohtuvayre™ (ensifentrine)의 만성 폐쇄성 폐질환(COPD) 치료를 위한 3상 ENHANCE 연구의 추가 분석 결과를 ERS International Congress 2024에서 발표한다고 발표했습니다. 발표 내용에는 하나의 구두 발표와 세 개의 포스터가 포함되어 있으며, 다양한 COPD 환자 하위 그룹에서 Ohtuvayre의 효능과 안전성을 강조합니다.

Ohtuvayre는 PDE3 및 PDE4의 최초의 이중 억제제로, 기관지 확장제와 항염증 효과를 결합합니다. 주요 발견에는 폐 기능 개선, 악화율 감소 및 다양한 환자 집단에서의 삶의 질 향상이 포함됩니다. 이 분석은 Ohtuvayre가 광범위한 COPD 환자에게 혜택을 줄 수 있는 잠재력을 지지하며, 20년 이상 만성 폐쇄성 폐질환 유지 치료를 위한 새로운 흡입 메커니즘의 첫 번째 사례를 기록합니다.

Verona Pharma (Nasdaq: VRNA) annonce les présentations d'analyses supplémentaires de ses études de Phase 3 ENHANCE concernant Ohtuvayre™ (ensifentrine) pour le traitement de la BPCO lors du ERS International Congress 2024. Les présentations comprennent une intervention orale et trois affiches, mettant en avant l'efficacité et la sécurité d'Ohtuvayre dans divers sous-groupes de patients atteints de BPCO.

Ohtuvayre, un inhibiteur double de première classe de PDE3 et PDE4, combine des effets bronchodilatateurs et anti-inflammatoires. Les résultats clés incluent des améliorations de la fonction pulmonaire, une réduction des taux d'exacerbation et une meilleure qualité de vie dans différentes populations de patients. Les analyses soutiennent le potentiel d'Ohtuvayre à bénéficier à une large gamme de patients atteints de BPCO, marquant le premier mécanisme inhalé novateur pour le traitement de maintien de la BPCO depuis plus de 20 ans.

Verona Pharma (Nasdaq: VRNA) kündigt die Präsentation zusätzlicher Analysen seiner Phase-3-Studien ENHANCE zu Ohtuvayre™ (ensifentrine) zur Behandlung von COPD auf dem ERS International Congress 2024 an. Die Präsentationen umfassen einen mündlichen Vortrag und drei Poster und heben die Wirksamkeit und Sicherheit von Ohtuvayre in verschiedenen COPD-Patientenuntergruppen hervor.

Ohtuvayre, ein erstes duales Inhibitormittel von PDE3 und PDE4, vereint bronchodilatatorische und entzündungshemmende Wirkungen. Zu den wichtigsten Ergebnissen gehören Verbesserungen der Lungenfunktion, reduzierte Exazerbationsraten und eine verbesserte Lebensqualität in verschiedenen Patientengruppen. Die Analysen unterstützen das Potenzial von Ohtuvayre, eine breite Palette von COPD-Patienten zu profitieren, und markieren den ersten neuartigen inhalativen Mechanismus für die Erhaltungstherapie bei COPD seit über 20 Jahren.

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 plcTel: +1-844-341-9901
Victoria Stewart, Senior Director of Investor Relations and CommunicationsIR@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.

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