UK-based Verona Pharma announced that its partner Nuance Pharma dosed the first patient in its Phase III trial investigating ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
Nuance Pharma, based in Shanghai, China, is planning to enrol 488 patients with moderate to severe COPD. The ENHANCE – China trial (NCT05743075) will evaluate the safety and efficacy of ensifentrine over 24 weeks and take place in China.
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Ensifentrine is a selective dual inhibitor of PDE3 and PDE4 enzymes, combining bronchodilator and non-steroidal anti-inflammatory activities.
In 2021, Nuance Pharma entered into an agreement with Verona Pharma for exclusive development and commercialisation rights of ensifentrine in Greater China, in addition to potential milestone payments of up to $179 million and royalties.
Nuance Pharma is also conducting a Phase I trial (NCT05758428) evaluating ensifentrine’s pharmacokinetics, safety and tolerability in healthy Chinese participants. The company dosed the first volunteer in March 2023.
Ensifentrine already met the primary and key secondary endpoints in Verona Pharma’s Phase III ENHANCE-1 trial (NCT04535986). In December 2022, the company announced that the drug demonstrated significant improvements in lung function, symptoms, and quality of life measures.
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By GlobalDataAdditionally, ensifentrine reduced the risk of COPD exacerbations by 36% and was well tolerated over 24 and 48 weeks. Verona Pharma is planning to submit a New Drug Application (NDA) to the FDA in the first half of 2023.
David Zaccardelli, president and CEO of Verona Pharma, said that the initiation of the ENHANCE – China trial is a significant milestone and the efficacy seen in the Phase III trial will help to address the urgent global need for novel therapies to treat COPD.
COPD is a chronic inflammatory lung disease that causes the obstruction of airflow from the lungs. According to the World Health Organization (WHO), COPD is the third leading cause of death globally, and caused 3.23 million deaths in 2019.
COPD is included in the WHO’s Global Action Plan for the Prevention and Control of Noncommunicable Diseases (NCDs), with the aim to extend diagnosis and treatment for COPD. The United Nations has also added the disease to its 2030 Agenda for Sustainable Development. Currently, there is no available cure for COPD, but there are several treatment options that can alleviate the symptoms and control disease progression.
A recent study found that CAPTURE (COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool was able to identify previously undiagnosed primary care patients with moderate to severe COPD. GlobalData epidemiologists suggest that diagnosed cases are likely to increase over the upcoming years as this tool is more widely utilised.
