Verona Pharma to Present Further Analyses of Positive Phase 3 ENHANCE Studies in COPD at ATS 2024

Verona Pharma plc, a biopharmaceutical company listed on Nasdaq, has announced that it will present eight posters, including two oral symposiums, at the American Thoracic Society International Conference (ATS) 2024. These presentations will cover additional analyses from the company's successful Phase 3 ENHANCE studies of ensifentrine, an investigational treatment for chronic obstructive pulmonary disease (COPD). Ensifentrine is notable for being a first-in-class, selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4), offering both bronchodilator and anti-inflammatory effects without steroids.

The data to be presented includes pooled analyses from the ENHANCE-1 and ENHANCE-2 trials, which demonstrated that ensifentrine significantly reduced the rate and risk of COPD exacerbations and improved lung function. These findings were first reported in late 2022. The presentations are intended to highlight new breakthroughs and are part of a 'Late Breaking Mini Symposium.' The posters are also available on the ATS website and published in the American Journal of Respiratory and Critical Care Medicine.

Ensifentrine is under review by the U.S. Food and Drug Administration (FDA). If approved, it would be the first novel inhaled treatment for COPD maintenance in over 20 years. The FDA has set a PDUFA Target Action Date of June 26, 2024, for the review.

The eight posters will summarize the efficacy and safety of ensifentrine when added to long-acting muscarinic antagonist (LAMA) therapy or a combination of long-acting beta-agonist and inhaled corticosteroids (LABA/ICS). Key findings include the reduction of exacerbation rates regardless of eosinophil count, delayed progression of exacerbations, and improvement in dyspnea. Additionally, Verona Pharma will host an exhibition booth to discuss the role of phosphodiesterase in inflammation and lung function impairment in COPD.

Dr. Frank Sciurba of the University of Pittsburgh School of Medicine noted that the pooled analyses provide strong evidence of ensifentrine's potential as a significant treatment option for a broad population of COPD patients. He highlighted the substantial reduction in exacerbation rate and risk as particularly promising.

Details of Verona Pharma’s presentations include:

- Late-Breaking Mini Symposium: Presented by Dr. Frank Sciurba, focusing on ensifentrine's ability to reduce exacerbation frequency and delay progression from Gold B to Gold E stages of COPD.
- Mini Symposium: Presented by Dr. Mark Dransfield of the University of Alabama, discussing the improvement in lung function and reduction of exacerbations when ensifentrine is added to LAMA therapy.
- Poster Presentations:
- Dr. Frank Sciurba will present findings on the reduction of moderate/severe exacerbation rates with ensifentrine.
- Dr. Nathan Marchetti will discuss improvements in lung function and exacerbation rates when ensifentrine is added to LABA/ICS therapy.
- Dr. Dave Singh will present pooled data on improvements in breathlessness and quality of life.
- Dr. Ravi Kalhan will cover quality of life improvements with ensifentrine added to LAMA therapy.
- Dr. Donald Mahler will discuss dyspnea improvement over 24 weeks.
- Dr. Antonio Anzueto will present on quality of life and dyspnea improvements when ensifentrine is added to LABA/ICS therapy.

Verona Pharma is dedicated to developing innovative therapies for chronic respiratory diseases with significant unmet medical needs. Ensifentrine not only shows promise for COPD but also has potential applications in other respiratory conditions like cystic fibrosis, non-cystic fibrosis bronchiectasis, and asthma. Additionally, the company is exploring multiple formulations of ensifentrine, including dry powder inhaler (DPI) and pressurized metered-dose inhaler (pMDI).

In summary, Verona Pharma's upcoming presentations at ATS 2024 will further elucidate the potential of ensifentrine as a transformative treatment for COPD, pending FDA approval by the PDUFA date of June 26, 2024.

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