Verona Pharma to Present Six Analyses of the Phase 3 ENHANCE Studies in COPD at CHEST 2024
Verona Pharma announces six analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for COPD treatment to be presented at CHEST 2024. The presentations include four oral and two poster sessions, highlighting Ohtuvayre's efficacy and safety in various COPD patient subgroups. Key findings show improvements in lung function, symptoms, and quality of life, as well as reduced exacerbation rates, regardless of COPD severity, smoking status, or chronic bronchitis presence.
Ohtuvayre, a first-in-class dual inhibitor of PDE3 and PDE4, combines bronchodilator and anti-inflammatory effects. It's the first novel inhaled mechanism for COPD maintenance treatment in over 20 years. The analyses will also present data on Ohtuvayre's impact on reducing COPD-related healthcare resource utilization over 48 weeks.
Verona Pharma annuncia sei analisi dei suoi studi di fase 3 ENHANCE con Ohtuvayre (ensifentrine) per il trattamento della BPCO che saranno presentate al CHEST 2024. Le presentazioni includono quattro sessioni orali e due sessioni poster, evidenziando l'efficacia e la sicurezza di Ohtuvayre in vari sottogruppi di pazienti con BPCO. I risultati chiave mostrano miglioramenti nella funzione polmonare, nei sintomi e nella qualità della vita, oltre a una riduzione delle aliquote di esacerbazione, indipendentemente dalla gravità della BPCO, dallo stato di fumatore o dalla presenza di bronchite cronica.
Ohtuvayre, un inibitore doppio di PDE3 e PDE4 di prima classe, combina effetti broncodilatatori e anti-infiammatori. È il primo meccanismo inalatorio innovativo per il trattamento di mantenimento della BPCO in oltre 20 anni. Le analisi presenteranno anche dati sull'impatto di Ohtuvayre sulla riduzione dell'utilizzo delle risorse sanitarie correlate alla BPCO nel corso di 48 settimane.
Verona Pharma anuncia seis análisis de sus estudios de fase 3 ENHANCE con Ohtuvayre (ensifentrine) para el tratamiento de la EPOC que se presentarán en CHEST 2024. Las presentaciones incluirán cuatro sesiones orales y dos sesiones de póster, destacando la eficacia y seguridad de Ohtuvayre en varios subgrupos de pacientes con EPOC. Los hallazgos clave muestran mejoras en la función pulmonar, los síntomas y la calidad de vida, así como tasas de exacerbación reducidas, independientemente de la gravedad de la EPOC, el estado de fumador o la presencia de bronquitis crónica.
Ohtuvayre, un inhibidor dual de PDE3 y PDE4 de primera clase, combina efectos broncodilatadores y antiinflamatorios. Es el primer mecanismo inhalado novedoso para el tratamiento de mantenimiento de la EPOC en más de 20 años. Los análisis también presentarán datos sobre el impacto de Ohtuvayre en la reducción de la utilización de recursos sanitarios relacionados con la EPOC durante 48 semanas.
베로나 파마는 Ohtuvayre (ensifentrine)의 COPD 치료를 위한 3상 ENHANCE 연구에서 6개의 분석 결과를 발표할 예정이며, 이는 CHEST 2024에서 소개됩니다. 발표 내용은 Ohtuvayre의 다양한 COPD 환자 하위 그룹에서의 효능과 안전성을 강조하며, 4개의 구두 발표와 2개의 포스터 세션이 포함됩니다. 주요 발견 사항은 폐 기능, 증상 및 삶의 질의 개선과 함께 악화율 감소를 보여주며, 이는 COPD의 중증도, 흡연 상태 또는 만성 기관지염의 존재와 관계없이 나타납니다.
Ohtuvayre는 PDE3 및 PDE4의 첫 번째 클래스 이중 억제제로, 기관지 확장제와 항염 효과를 결합합니다. 이는 20년 만에 COPD 유지 치료를 위한 새로운 흡입 메커니즘입니다. 분석에서는 Ohtuvayre가 COPD 관련 의료 자원 활용도 감소에 미치는 영향에 대한 데이터도 발표할 예정입니다.
Verona Pharma annonce six analyses de ses études de phase 3 ENHANCE avec Ohtuvayre (ensifentrine) pour le traitement de la BPCO qui seront présentées à CHEST 2024. Les présentations comprennent quatre séances orales et deux séances d'affiches, mettant en avant l'efficacité et la sécurité d'Ohtuvayre dans divers sous-groupes de patients atteints de BPCO. Les principaux résultats montrent des améliorations de la fonction pulmonaire, des symptômes et de la qualité de vie, ainsi qu'une réduction des taux d'exacerbation, quelle que soit la gravité de la BPCO, le statut tabagique ou la présence de bronchite chronique.
Ohtuvayre, un inhibiteur double de PDE3 et PDE4 de première classe, combine des effets bronchodilatateurs et anti-inflammatoires. C'est le premier mécanisme inhalé innovant pour le traitement de maintien de la BPCO depuis plus de 20 ans. Les analyses présenteront également des données sur l'impact d'Ohtuvayre sur la réduction de l'utilisation des ressources de santé liées à la BPCO sur 48 semaines.
Verona Pharma kündigt sechs Analysen aus seinen Phase 3 ENHANCE-Studien mit Ohtuvayre (ensifentrine) zur Behandlung von COPD an, die auf CHEST 2024 präsentiert werden. Die Vorträge umfassen vier mündliche Präsentationen und zwei Poster-Sitzungen, die die Wirksamkeit und Sicherheit von Ohtuvayre in verschiedenen COPD-Patientensubgruppen hervorheben. Wichtige Ergebnisse zeigen Verbesserungen in der Lungenfunktion, den Symptomen und der Lebensqualität sowie reduzierte Exazerbationsraten, unabhängig von der Schwere der COPD, dem Rauchverhalten oder der Anwesenheit von chronischer Bronchitis.
Ohtuvayre, ein erstklassiger dualer Hemmer von PDE3 und PDE4, kombiniert bronchodilatatorische und entzündungshemmende Effekte. Es ist der erste neuartige Inhalationsmechanismus zur Erhaltungstherapie von COPD seit über 20 Jahren. Die Analysen werden auch Daten über die Auswirkungen von Ohtuvayre auf die Reduzierung der COPD-bezogenen Inanspruchnahme von Gesundheitsressourcen über 48 Wochen präsentieren.
- Ohtuvayre met primary endpoints in ENHANCE-1 and ENHANCE-2 trials, showing significant lung function improvements
- Demonstrated efficacy across various COPD patient subgroups, including different severities and smoking statuses
- Reduced exacerbation rates and COPD-related healthcare resource utilization over 48 weeks
- First novel inhaled mechanism for COPD maintenance treatment in over 20 years
- None.
Data support Ohtuvayre™ (ensifentrine), as a first-in-class, selective, dual inhibitor of PDE3 and PDE4 in a broad COPD population
LONDON and RALEIGH, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”) announces four oral presentations and two posters on analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease (“COPD”) will be presented at CHEST Annual Meeting (“CHEST”) 2024. The analyses are published in the CHEST Annual Meeting on-line supplement.
Ohtuvayre (ensifentrine) is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase three and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre 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 subgroups of COPD patients including data supporting improvements in lung function, symptoms and quality of life, as well as reductions in the rate of exacerbations, regardless of COPD severity (moderate or severe), smoking status (current or former), and chronic bronchitis (with or without). Furthermore, an analysis of ensifentrine’s impact on reducing exacerbation rates and COPD-related healthcare resource utilization over 48 weeks will also be presented.
“Ensifentrine is a remarkable addition to COPD therapy,” said William Stringer, MD, FCCP, Professor of Medicine in the David Geffen School of Medicine at UCLA. “It has the capacity to bronchodilate, reduce inflammation, augment mucociliary clearance, and reduce exacerbations in smokers and former smokers.”
Details of Verona Pharma’s presentations and posters are listed below and linked to the CHEST website. In addition, the Company will present five presentations that will highlight the unmet need in COPD based on real world claims data.
Oral presentation: Ensifentrine improved lung function, symptoms, and quality of life regardless of COPD severity
Presenter: Jessica Bon, MD, Wake Forest University School of Medicine
Session: Assessing Treatment Outcomes in Obstructive Lung Disease
Oral presentation: Ensifentrine, a novel COPD treatment, reduced COPD-related healthcare resource utilization over 48 weeks
Presenter: Emily Wan, MD, Brigham and Women’s Hospital and Harvard Medical School
Session: Emerging Treatments in Obstructive Lung Disease
Oral presentation: Ensifentrine improved lung function in patients with moderate to severe COPD: a pooled analysis from the Phase 3 ENHANCE trials
Presenter: Diego J. Maselli Caceres, MD, FCCP, Division of Pulmonary Diseases and Critical Care, UT Health San Antonio
Session: Emerging Treatments in Obstructive Lung Disease
Oral presentation: Ensifentrine improved lung function and reduced exacerbation rate and risk in patients with COPD regardless of smoking status
Presenter: Amy Dixon, PharmD, Verona Pharma
Session: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease
Poster 3513: Ensifentrine improved symptoms and quality of life in patients with moderate-to-severe COPD regardless of smoking status
Presenter: William Stringer, MD, FCCP, David Geffen School of Medicine at UCLA
Session: Novel Therapeutic Targets and Interventions in Obstructive Lung Disease
Poster 4285: Ensifentrine improved symptoms and quality of life in patients with COPD regardless of bronchitis history
Presenter: Jill Ohar, MD, Wake Forest University School of Medicine
Session: Lung Disease Abstracts Posters
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
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