Pharma Focus Europe

Nuance Pharma Announces Dosing of First Patient in ENHANCE – China Phase 3 Trial for COPD

Tuesday, April 11, 2023

Verona Pharma plc, a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its development partner, Nuance Pharma, has dosed the first subject in its ENHANCE - China Phase 3 trial for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).

In August 2022, Nuance Pharma received clearance from the Center of Drug Evaluation (“CDE”) for its Investigational New Drug (“IND”) application to conduct both Phase 1 and Phase 3 studies with ensifentrine for the maintenance treatment of COPD in mainland China. Nuance Pharma initiated a Phase 1 trial with ensifentrine in healthy volunteers in March 2023.

“We are pleased our development partner, Nuance Pharma, has begun pivotal studies in COPD with ensifentrine in mainland China,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “This is a significant milestone and, based on our recent highly positive Phase 3 results in COPD, we are excited about the potential of ensifentrine to address the urgent global need for a novel therapy for COPD.”

In 2021, Nuance Pharma entered into an agreement with Verona Pharma for exclusive rights to develop and commercialize ensifentrine in Greater China, with future potential milestone payments up to $179 million plus royalties.

Further information about these trials can be found at www.clinicaltrials.gov, ENHANCE - China Phase 3 trial (RPL554 - CPC001; NCT05743075), Phase 1 trial (RPL554 - AHC001; NCT05758428).

 

Source: globenewswire.com

magazine-slider-img
Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024
cytiva