Verona Prepares for First COPD Approval in a Decade

Patients suffering from chronic obstructive pulmonary disease (COPD) might soon have a new treatment option with fewer side effects, as Verona Pharma gears up for a potential approval. This week, the FDA is expected to make a decision regarding the New Drug Application for Verona’s ensifentrine, designed to treat COPD—a condition characterized by restricted airflow to the lungs, making breathing difficult. If approved, ensifentrine would be the first novel mechanism for the maintenance treatment of COPD in over ten years.

David Mannino, co-founder and chief medical officer at the COPD Foundation, emphasized the benefits of this therapy, noting that it is inhaled, has fewer side effects compared to existing treatments, and does not elevate heart rate.

The American Lung Association states there is no cure for COPD, but multiple drugs exist to manage its symptoms. These medications include bronchodilators, which relax the muscles around the airways, and corticosteroids, which decrease inflammation, swelling, and mucus production. Ensifentrine would be unique in that it acts both as a non-steroidal anti-inflammatory and a bronchodilator, said Verona’s President and CEO David Zaccardelli. This dual action could benefit patients who experience side effects from steroid-based COPD drugs, such as an increased risk of pneumonia, oral thrush, and infections. Traditionally, doctors have resorted to steroids to help patients with exacerbated symptoms due to a lack of alternatives.

Ensifentrine stands out due to its unique mechanism of action. It functions as both a phosphodiesterase 3 and phosphodiesterase 4 inhibitor, producing both bronchodilation and non-steroidal anti-inflammatory effects. Antonio Anzueto, a professor of medicine and section chief of pulmonary at South Texas Veterans Healthcare System, who participated in Verona’s trials, stated that this dual action is unprecedented in COPD treatment.

The Phase III ENHANCE trials demonstrated promising results for ensifentrine, showing significant benefits for lung function and quality of life. According to a December 2022 readout from ENHANCE-1, the drug reduced the risk of COPD exacerbations by 36% over 24 weeks compared to a placebo. Anzueto believes ensifentrine could serve as a first-line therapy or maintenance treatment in conjunction with other medications, suggesting that all COPD patients might be eligible.

Another advantage of ensifentrine is its patient-friendly administration. Unlike some COPD medicines that require a healthcare professional for administration, ensifentrine can be used directly by patients via a nebulizer. According to Zaccardelli, the administration process takes about five to seven minutes and is straightforward.

If approved, ensifentrine could address a significant unmet need. Nearly 16 million Americans live with COPD, as per the National Heart, Lung, and Blood Institute. Due to the chronic and progressive nature of the disease, its symptoms, such as cough with sputum and shortness of breath, worsen over time. The number of deaths due to COPD is significantly higher among older age groups, with nearly 85% of COPD deaths occurring in individuals aged 65 and older.

Mannino pointed out that while smoking rates—a major contributor to COPD—have decreased in the U.S., the disease rate has remained constant due to the aging population. He estimated that there might be nearly 15 million undiagnosed COPD patients in the country.

Despite the high demand for new COPD treatments, the pricing of ensifentrine remains uncertain, leading experts to question its accessibility. Mannino noted that the price and insurance coverage would significantly impact the drug’s accessibility, suggesting it might be more expensive than current maintenance therapies. Verona’s Chief Commercial Officer Christopher Martin mentioned that the company has not yet decided on the drug’s price.

Nevertheless, Zaccardelli expressed optimism regarding the drug’s approval, highlighting the significant number of patients in the U.S. who remain symptomatic despite current treatments. To support the launch of ensifentrine, Verona has secured substantial financial backing, including $400 million from Oxford Finance and Hercules Capital, and up to $650 million in a strategic financing agreement with Oaktree Capital Management and OMERS Life Sciences. Zaccardelli affirmed that the company is well-financed to support the drug’s launch.