Verona Pharma plc (Nasdaq: VRNA) is thrilled to announce that its development partner, Nuance Pharma, has successfully dosed the first subject in the ENHANCE – China Phase 3 trial for the maintenance treatment of COPD. This marks a key milestone for the Company in its efforts to provide clinical-stage biopharmaceutical solutions for respiratory diseases.
In August 2022, following the approval of its Investigational New Drug (IND) application by the Center of Drug Evaluation (CDE), Nuance Pharma was given the green light to initiate Phase 1 and Phase 3 studies with ensifentrine for the maintenance treatment of COPD in mainland China. March 2023 saw the launch of the Phase 1 trial with ensifentrine in healthy volunteers, marking an exciting milestone in the company’s journey.
Verona Pharma is delighted to announce that Nuance Pharma, its development partner, has initiated pivotal studies in COPD with ensifentrine in mainland China. Following the positive results of its Phase 3 trials in COPD, the company is hopeful that ensifentrine will be able to meet the urgent global need for a novel therapy for this condition. As a result, David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma, expresses his enthusiasm for this significant milestone.
In 2021, Nuance Pharma and Verona Pharma joined forces in a landmark agreement, granting Nuance Pharma exclusive rights to develop and commercialize Verona Pharma’s innovative product ensifentrine in Greater China. This agreement could potentially yield milestone payments of up to $179 million, plus royalties, for Verona Pharma.
About Verona Pharma
Verona Pharma is revolutionizing the treatment of chronic respiratory diseases with its innovative, multi-faceted product candidate, ensifentrine.
The potential of this compound to combine bronchodilator and anti-inflammatory activities into one treatment has the potential to revolutionize the field. In the Phase 3 ENHANCE clinical program, ensifentrine demonstrated statistically significant and clinically meaningful improvements in lung function, as well as a significantly reduced rate and risk of COPD exacerbations.
Verona Pharma is aiming to submit a New Drug Application to the US Food and Drug Administration in the second quarter of 2023. Additionally, ensifentrine has been evaluated in Phase 2 studies for the treatment of COPD for dry powder inhaler and pressurized metered-dose inhaler applications, and may have potential applications in cystic fibrosis, asthma and other respiratory diseases.
About Nuance Pharma
Nuance Pharma is a biopharmaceutical powerhouse that specializes in providing critical medical treatments to those in need. Our mission is to improve healthcare in the Asia Pacific region with an innovative dual wheel model.
This allows us to not only develop a leading pipeline of breakthrough treatments, but also to maintain a self-sustaining commercial operation in both China and Asia.
Our focus lies in providing specialty care for respiratory, pain management, emergency care and iron deficiency anemia. With Nuance Pharma, patients can be sure they’re receiving the best treatments available.