Ensifentrine Shows Promise in Phase 3 Studies for COPD Treatment, Verona Pharma Reports

Verona Pharma, a clinical-stage biopharmaceutical company, has announced the presentation of additional analyses from its Phase 3 ENHANCE studies at the CHEST Annual Meeting 2023. The studies evaluated the potential of ensifentrine, an investigational dual inhibitor of PDE3 and PDE4, for the treatment of chronic obstructive pulmonary disease (COPD).

The pooled analyses from the ENHANCE-1 and ENHANCE-2 studies demonstrated that treatment with ensifentrine led to significant reductions in the rate and risk of COPD exacerbations, regardless of patients’ recent exacerbation history. These findings highlight ensifentrine’s potential as an effective novel treatment for COPD patients. The drug was also well-tolerated by patients.

Subgroup data analyses showcased improvements in lung function, symptoms, quality of life endpoints, and reductions in exacerbation rates and risks, irrespective of background therapy. Additionally, ensifentrine showed a reduction in daily rescue medication use. These results further support the potential of ensifentrine to benefit a broad population of COPD patients.

Dr. Frank Sciurba, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, commented on the additional analyses, stating that ensifentrine’s combined bronchodilator and non-steroidal anti-inflammatory activity could bring meaningful benefits to COPD patients if approved.

Verona Pharma’s presentations at the CHEST Annual Meeting covered various aspects of ensifentrine’s potential, including its ability to reduce exacerbation rates and risks, improve lung function and symptoms, enhance quality of life, and decrease rescue medication use.

Verona Pharma’s ensifentrine is currently under review by the US Food and Drug Administration (FDA) for the maintenance treatment of COPD. The FDA has accepted the New Drug Application (NDA) for ensifentrine and assigned a PDUFA target action date of June 26, 2024.

Verona Pharma is focused on developing and commercializing innovative therapies for chronic respiratory diseases with significant unmet medical needs. Ensifentrine, if successfully developed and approved, has the potential to become the first non-steroidal therapy for respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule.

In addition to COPD, Verona Pharma is exploring the potential applications of ensifentrine in cystic fibrosis, asthma, and other respiratory diseases. The company has evaluated different formulations of ensifentrine, including a dry powder inhaler (DPI) and a pressurized metered-dose inhaler (pMDI), in Phase 2 trials for COPD treatment.

Verona Pharma’s efforts to develop ensifentrine represent a significant step towards addressing the unmet medical needs of COPD patients and potentially changing the treatment paradigm for respiratory diseases. With the FDA review underway, the company remains committed to advancing the potential of ensifentrine as a novel treatment option for patients with COPD.