• Verona Pharma’s Ensifentrine, a dual inhibitor of PDE3 and PDE4, demonstrated both bronchodilatory and anti-inflammatory benefits. Pending FDA approval on June 26, 2024, it could be the first new inhaled COPD maintenance treatment in over 20 years, potentially launching in the third quarter of 2024.
• Verona Pharma is going to present analyses of the positive Phase III ENHANCE studies in ATS 2024 showcasing ensifentrine’s significant efficacy in COPD treatment, with substantial reductions in exacerbation rates and risks and notable improvements in lung function, symptoms, and quality of life.

Chronic Obstructive Pulmonary Disease (COPD) is a progressively debilitating respiratory condition impacting millions globally, leading to significant morbidity and mortality. The Chronic Obstructive Pulmonary Disease Epidemiology Forecast by DelveInsight reported 34 million diagnosed prevalent cases in the 7MM in 2023. The rising burden of COPD is significantly driven by unmet treatment needs. Exacerbations in COPD exacerbate this burden by causing a swift decline in lung function, leading to increased healthcare costs, frequent hospitalizations, and a diminished quality of life. These acute episodes not only demand immediate medical attention but also accelerate the overall progression of the disease, thereby contributing to long-term morbidity and heightened mortality rates. 

At the 2024 American Thoracic Society (ATS) International Conference, Verona Pharma presented additional analyses of the positive Phase III ENHANCE studies in COPD. The studies showcased ensifentrine’s potential as a therapy for COPD patients, highlighting a substantial reduction in exacerbation rate and risk with ensifentrine. The presentations included eight posters and two mini-oral symposia, demonstrating improvements in lung function, reduced exacerbations, and enhanced quality of life in COPD patients. Various presenters from institutions like the University of Pittsburgh, Temple University, University of Manchester, and Northwestern University discussed the positive outcomes of ensifentrine in COPD treatment.

Ensifentrine, a unique dual inhibitor of PDE3 and PDE4 enzymes, targets COPD by simultaneously relaxing airway muscles and reducing inflammation. This novel approach combines bronchodilation and anti-inflammatory effects in a single treatment, setting it apart from traditional medications for COPD. 

The Phase III ENHANCE-1 and ENHANCE-2 trials for ensifentrine in COPD successfully met their primary and secondary endpoints. Ensifentrine demonstrated significant improvements in lung function, symptoms, quality of life, and reductions in exacerbation rates and risks. The trials’ primary endpoints, such as the FEV1 area under the curve and trough FEV1, indicated the drug’s efficacy in enhancing lung function. Additionally, the secondary endpoints, which included symptom improvement and quality of life assessments, also showed positive outcomes.

The results of the ENHANCE-1 and ENHANCE-2 trials were interpreted from a clinical pharmacological perspective, highlighting ensifentrine’s bifunctional characteristics as a selective dual inhibitor of PDE3/4. The analysis suggested that ensifentrine’s predominant broncho-relaxant effect is due to PDE3 inhibition, while its anti-inflammatory activity through PDE4 inhibition may contribute to the reduction in exacerbations.

Overall, the analyses will be presented at ATS 2024, which will further provide evidence of ensifentrine’s potential as an important therapy for a broad population of COPD patients, with significant improvements in lung function, symptoms, and reductions in exacerbation rates and risk. 

A key highlight from the conference will present the comprehensive data illustrating ensifentrine’s efficacy across a diverse patient population. These findings can underscore its potential to address unmet needs in COPD management, particularly in patients with frequent exacerbations and those who do not respond adequately to current therapies.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for June 26, 2024. If approved, the company plans to introduce ensifentrine to the US market in the third quarter of 2024, potentially providing a new treatment option for COPD patients. This timely launch could significantly impact patient care by offering an effective therapy to improve lung function and quality of life. 

Ensifentrine is a valuable addition to current COPD treatments. DelveInsight’s ‘Chronic Obstructive Pulmonary Disease (COPD)-Market Insights, Epidemiology, and Market Forecast report indicates the COPD market was valued at USD 12.6 billion in 2023, with expectations for growth following the approval of new drugs like Ensifentrine.