Nuance Pharma announces dosing of first patient in the ENHANCE - China Phase III Trial for the maintenance treatment of chronic obstructive pulmonary disease of its novel solution Ensifentrine in mainland China.

Ensifentrine is a first-in-class, selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and non-steroidal anti-inflammatory activities in one compound. This activity has the potential to alleviate respiratory symptoms such as breathlessness and cough, as well as providing anti-inflammatory benefits for those with COPD.

Ensifentrine Study in China

On August 17th, 2022, Nuance Pharma announced the IND approval from the Center for Drug Evaluation (CDE) for supporting its pivotal Phase I and Phase III clinical trials of Ensifentrine in the maintenance treatment of COPD.

March 9th, 2023, Nuance Pharma completed first dosing of the first healthy subject in the Phase I trial (RPL554 - AHC001; NCT05758428), a PK, safety and tolerability study of nebulized Ensifentrine on healthy Chinese volunteers.

April 6th, 2023, Nuance Pharma announces the first COPD patient dosed in the ENHANCE - CHINA Phase III trial (RPL554 - CPC001; NCT05743075), a randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Ensifentrine over 24 weeks in patients with moderate to severe COPD.

"It gives me great pleasure to announce the first dosing of ENHANCE-China Phase III trial. This represents a crucial milestone for our collaboration with Verona Pharma and is indicative of a strong opening to the China clinical development program. Ensifentrine combines bronchodilator and non-steroidal anti-inflammatory properties in one compound, differentiating it from existing drug classes used to treat COPD" commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma. "We are looking forward to introducing this novel drug in Greater China to address unmet needs in the COPD market."

"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 III results in COPD, we are excited about the potential of ensifentrine to address the urgent global need for a novel treatment for COPD."

December 20th, 2022, Nuance's global partner Verona Pharma announced Ensifentrine met primary and key secondary endpoints in Phase III ENHANCE-1 trial for COPD, after positive readout for Phase III ENHANCE-2 trial for COPD in August 2022, another step closer to providing a much-needed novel therapy for COPD patients. Verona Pharma plans to submit a New Drug Application to the US Food and Drug Administration in the second quarter of 2023.

 

Source:prnewswire.com

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