Verona Gears Up for First Novel COPD Approval in Over a Decade
25 Jun 2024
Phase 3Clinical ResultAHADrug Approval
Pictured: Lungs over a background of the FDA and a man with a mask/Nicole Bean for BioSpace.
Patients with chronic obstructive pulmonary disease may soon have a new treatment option with fewer side effects as Verona Pharma prepares for a potential approval this week.
Wednesday, the FDA is set to decide on the New Drug Application for Verona’s ensifentrine, intended to treat chronic obstructive pulmonary disease (COPD), a condition in which patients have difficulty breathing due to restricted airflow to the lungs. If given the green light, ensifentrine would be the first novel mechanism available for the maintenance treatment of COPD in more than a decade, according to the company.
“What is different about this therapy is that it is inhaled, has fewer side effects relative to other therapies, and doesn't do things like increase the heart rate,” said David Mannino, co-founder and chief medical officer at the COPD FoundationCOPD Foundation. “We are excited about that.”
Novel Mechanism of Action
While according to the American Lung Association, there is no cure for COPD, several short-acting and long-acting drugs are available to manage the symptoms of the disease. These include bronchodilators, which relax the muscles around the airways, and anti-inflammatory steroidal drugs such as corticosteroids, which work by decreasing inflammation, swelling and mucus production inside the airways.
If approved, ensifentrine would be the first drug to work as both a non-steroidal anti-inflammatory and a bronchodilator, Verona President and CEO David Zaccardelli told BioSpace. This feature would especially benefit patients who face side effects from steroid-based COPD drugs, including increased risk of pneumonia, oral thrush and infections. “Before, doctors would have routinely gone to a steroid to help the patients who have exacerbated symptoms because they had no other choice,” Zaccardelli said.
He added that ensifentrine has a unique mechanism of action, which sets it apart from routinely administered COPD medicines. Verona’s drug works as both a phosphodiesterase 3 and phosphodiesterase 4 inhibitor, eliciting both bronchodilation and non-steroidal anti-inflammatory effects.
“It is one medicine acting as both a bronchodilator and anti-inflammatory medicine,” Antonio Anzueto, a professor of medicine and section chief of pulmonary at South Texas Veterans Healthcare System who was involved in Verona’s trials of ensifentrine, told BioSpace. “We have never seen that before.”
Ensifentrine showed promising results in the Phase III ENHANCE trials, which demonstrated its significant benefits on lung function and quality of life. According to a December 2022 readout from ENHANCE-1, Verona’s drug cut the risk of exacerbations associated with COPD by 36% over 24 weeks versus placebo.
Anzueto said he believes ensifentrine will serve as a first-line therapy or maintenance treatment along with other drugs. “I think all COPD patients will be eligible,” he said.
Another benefit is the drug’s patient-friendly administration. Unlike some other COPD medicines, which need to be administered by a health professional, ensifentrine can be used directly by patients via a nebulizer, Zaccardelli said. “It takes about five to seven minutes to administer it and it is fairly straightforward.”
High Demand, Unclear Access
If approved, ensifentrine could help meet a high unmet need. Nearly 16 million Americans are living with COPD, according to the National Heart, Lung, and Blood Institute. Given the chronic and progressive nature of the disease, the symptoms, including cough bringing up sputum and shortness of breath, worsen with age and time. The number and rate of deaths from COPD are much greater among older age groups, with nearly 85% of COPD deaths documented among people 65 years or older.
According to Mannino, there could be close to 15 million more people living with COPD who haven’t been diagnosed. While he noted that rates of smoking—a key COPD contributor—have fallen in the U.S., the disease rate has stayed the same due to an aging population. “I would say the number of patients living with COPD in the U.S. hasn’t changed much in the last ten years,” he told BioSpace.
While the demand is high, it is still unclear how ensifentrine will be priced, leading experts to question how accessible it will be. “It depends on how payers and insurers decide to cover it,” Mannino said. “It is probably a more expensive therapy relative to some of the maintenance therapies that we have on the market currently.”
Verona Chief Commercial Officer Christopher Martin told BioSpace the company has yet to decide on the drug’s price.
Zaccardelli did express confidence, however, that the drug will be approved. “The field has not had a new drug for a while,” he said. “Moreover, there is probably an excess of four million patients in the U.S. who remain symptomatic, even with the current standard of care.”
Verona has inked several financing deals to help facilitate ensifentrine’s launch. In January, the company announced it received $400 million from Oxford Finance and Hercules Capital, and last month, Verona secured up to $650 million in a strategic financing agreement with Oaktree Capital Management and OMERS Life Sciences. “We are very well financed and have access to cash to support the launch of ensifentrine,” Zaccardelli said.
Aayushi Pratap is a New York-based health and science journalist and an alum of Columbia Journalism School. Reach her on LinkedIn.
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