Dosing begins in ENHANCE China trial of ensifentrine for COPD
Phase 3 study of inhaled therapy similar to ones in North America, Europe
A first person with chronic obstructive pulmonary disease (COPD) has been dosed with ensifentrine, an inhaled medication in the pipeline of Verona Pharma, as part of a Phase 3 clinical trial that recently opened in China.
The trial, called ENHANCE China (NCT05743075), is evaluating the efficacy and safety of ensifentrine compared with a placebo over 24 weeks (about six months) in people with moderate-to-severe COPD. Recruitment is underway in Guangdong for adults, ages 40 to 80, with a COPD diagnosis.
Two Phase 3 trials also investigated ensifentrine’s effectiveness and safety in COPD patients at sites across the U.S., Europe, Canada, and Korea.
“This is a significant milestone,” David Zaccardelli, president and CEO of Verona, said in a company press release. “We are excited about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD.”
Ensifentrine designed to be a bronchodilator and anti-inflammatory agent
COPD comprises a group of lung diseases that cause inflammation and make breathing increasingly more difficult over time. People with COPD often experience shortness of breath, persistent cough and wheezing, and frequent lung infections.
Available COPD treatments are designed to help to slow its progression and control disease symptoms.
Ensifentrine works in two ways: as a bronchodilator that opens the airways so that breathing becomes easier, and as an anti-inflammatory that helps reduce inflammation in the lungs.
It does this by targeting two enzymes, phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4), that are involved in muscle contraction and airway inflammation. By blocking these enzymes, ensifentrine is expected to help improve breathing and lower inflammation at the same time.
“Ensifentrine combines bronchodilator and non-steroidal anti-inflammatory properties in one compound, differentiating it from existing drug classes used to treat COPD,” said Mark G. Lotter, CEO and co-founder of Nuance Pharma. Under an agreement with Verona, Nuance is advancing and could potentially market ensifentrine in China, Hong Kong, Macau, and Taiwan.
Nuance was given the go-ahead to launch ENHANCE China and a Phase 1 clinical trial (NCT05758428) evaluating the safety, tolerability, and pharmacological properties of ensifentrine in healthy volunteers last year.
Nebulized suspension treatment for moderate-to-severe COPD
ENHANCE China has three parts: an initial 28-day run-in period; a treatment period lasting 24 week; and a follow-up period taking place one week after the end of treatment.
Up to 488 patients will be randomly assigned to either 3 mg of ensifentrine as a nebulized suspension taken twice daily or to a placebo suspension for the 24 weeks. Each nebulization takes about five minutes to complete.
The study’s main goal is changes in the average forced expiratory volume in 1 second (FEV1) area under the curve, a measure of lung function, from the trial’s start to week 12 of treatment.
Secondary goals include the use of rescue medications, COPD symptoms, and health-related quality of life, all of which will be assessed every six weeks until the end of the treatment period.
Two previous Phase 3 clinical trials, ENHANCE-1 (NCT04535986) and ENHANCE-2 (NCT04542057), supported ensifentrine — used alone or as an add-on to a bronchodilator — in helping to improve lung function and reduce exacerbation rates in people with moderate to severe COPD. Exacerbations, also known as flares, are periods of disease worsening.
Ensifentrine also was reported to be safe and well tolerated by patients who took part in these clinical trials, with rates of adverse events similar between treatment and placebo groups.
Verona has announced plans to submit an application to the U.S. Food and Drug Administration, before the close of June, requesting that ensifentrine be approved to treat COPD.
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