A Q&A by Verona Pharma ahead of World Lung Cancer Day

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This World Lung Day, Verona Pharma is raising awareness of the debilitating burden of respiratory diseases, most specifically Chronic Obstructive Pulmonary Disease (COPD), which affects more than 384 million patients and is the third leading cause of death worldwide.

  • What is COPD and what are the current treatments available to those patients suffering with progressive loss of lung function and breathlessness?

Chronic Obstructive Pulmonary Disease (COPD) is the name for a common, progressive, respiratory condition that may include symptoms or signs of chronic bronchitis, emphysema or both. This condition leads to irreversible damage to airways and lungs, resulting in debilitating shortness of breath, hospitalizations and deaths.

COPD is the third leading cause of death worldwide affecting approximately 384 million patients, according to the Global Initiative for Chronic Obstructive Pulmonary Disease. It has a major impact on everyday life. Patients struggle with basic activities such as getting up, showering, eating and walking and frequently have difficulty sleeping. In addition, it prevents patients from socializing and enjoying hobbies, which may result in anxiety and depression.

Currently, COPD has no cure, but treatment can help to alleviate symptoms, reduce the risk of exacerbations, and improve patients’ quality of life. Standard of care is currently limited to three mechanisms of action, which may be used in combination:

  • long acting muscarinic agents (LAMAs)
  • long acting beta-adrenoceptor agonists (LABAs)
  • and inhaled corticosteroids (ICS)

LAMAs and LABAs are bronchodilators, designed to relieve airway narrowing and make it easier to breathe, while ICS act as anti-inflammatory agents designed to prevent exacerbations in certain patients, periods where symptoms suddenly escalate.

In addition to these therapies, some COPD patients receive the phosphodiesterase (PDE) 4 inhibitor, roflumilast. It has been shown to reduce the risk of exacerbations but its oral delivery results in side-effects such as unfavourable gastro-intestinal side-effects.

Unfortunately, despite the availability of these COPD treatments, alone or in combination, many patients remain symptomatic with their wellbeing severely compromised. They urgently require an alternative to existing treatments.

  • What is Verona Pharma doing to help alleviate the symptoms of patients suffering with the respiratory disease COPD?

We are developing ensifentrine, a first-in-class, inhaled, dual phosphodiesterase (PDE) 3 and 4 inhibitor, with the potential to be an effective daily therapy for COPD. It acts both as a bronchodilator, relieving the narrowing of the airways in COPD that contribute to shortness of breath, and an anti-inflammatory, reducing the risk of exacerbations. These attributes potentially differentiate ensifentrine from available COPD therapies.

We are evaluating nebulized ensifentrine in a Phase 3 clinical program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy) for COPD maintenance treatment. In August 2022, we announced positive Phase 3 top-line data from our ENHANCE-2 trial where ensifentrine met the primary endpoint demonstrating a statistically significant improvement in lung function, link to press release here. In the ENHANCE-2 trial, ensifentrine also significantly reduced the rate of COPD exacerbations and was well tolerated with a safety profile similar to placebo.

We continue to evaluate ensifentrine in our ongoing Phase 3 trial, ENHANCE-1, which is expected to report around the end of 2022.

  • What difference can Verona Pharma’s treatment, ensifentrine, make to the daily lives of COPD patients?

If approved, ensifentrine would be the first therapeutic with a novel mode of action for COPD in over a decade. We believe it will help to improve lung function, reduce the risk of exacerbations, and potentially improve symptoms and quality of life for COPD patients, providing a much needed alternative to existing treatments.

  • Can ensifentrine provide hope for patients suffering with other respiratory diseases?

In addition to COPD, we believe ensifentrine has potential applications in other respiratory conditions including cystic fibrosis (CF) and asthma. Ensifentrine has demonstrated potential in Phase 2a clinical trials in both these indications.

  • What is next for Verona Pharma?

We are looking forward to announcing top-line data from our ongoing Phase 3 trial, ENHANCE-1, in COPD around the end of 2022. If similar positive results are achieved, we plan to submit a New Drug Application to the US Food and Drug Administration for ensifentrine for the maintenance treatment of COPD in the first half of 2023.