Nuance Pharma Announces Dosing of First Patient in ENHANCE - China Phase III Trial for Chronic Obstructive Pulmonary Disease ("COPD")

Rhea-AI Summary

Nuance Pharma has initiated dosing for the first patient in the ENHANCE - China Phase III Trial, focusing on the maintenance treatment of chronic obstructive pulmonary disease (COPD) using Ensifentrine. This innovative drug is a first-in-class dual inhibitor of phosphodiesterase enzymes, which combines bronchodilation and anti-inflammatory effects. The trial represents a significant advancement in Nuance Pharma's collaboration with Verona Pharma, which recently reported positive outcomes from previous Phase III trials. Ensifentrine aims to deliver substantial improvements in lung function and quality of life for COPD patients. Verona Pharma plans to submit a New Drug Application to the FDA in Q2 2023 for Ensifentrine following these promising results.

Positive

• Initiation of Phase III trial for Ensifentrine in COPD marks a key milestone for Nuance Pharma.
• Ensifentrine shows strong potential with recent positive results from Phase III ENHANCE-1 and ENHANCE-2 trials.
• Ensifentrine's dual action as a bronchodilator and anti-inflammatory agent differentiates it from existing treatments.

Negative

• The success of the ENHANCE trial is contingent on further positive clinical results, introducing regulatory risk.
• The market for COPD treatments is competitive, posing potential challenges for market penetration of Ensifentrine.

SHANGHAI, April 6, 2023 /PRNewswire/ -- Nuance Pharma ("the Company") announces dosing of first patient in the ENHANCE - China Phase III Trial for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") 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 17^th, 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 9^th, 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 6^th, 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 20^th, 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.

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound. In Phase II clinical studies in COPD, ensifentrine has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator. In the Phase III ENHANCE-1 and ENHANCE-2 clinical trials, ensifentrine showed significant and clinically meaningful improvements in lung function measures and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 subjects to date.

About Nuance Pharma

Nuance Pharma is an innovation focused biopharmaceutical company, with both late-stage clinical pipeline and commercial stage asset portfolio. Focusing on specialty care, Nuance has established a differentiated combination of commercialized assets and innovative pipeline across respiratory, pain management, emergency care and iron deficiency anemia.

With the mission to address critical unmet medical needs in Asia Pacific, Nuance deploys the Dual Wheel model that develops a global leading innovative pipeline, while maintaining a self-sustainable commercial operation in both China and Asia as a region. For more information, please visit www.nuancepharma.com.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory diseases with significant unmet medical needs. If successfully developed and approved, Verona Pharma's product candidate, ensifentrine, has the potential to be the first therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one compound. The Company has evaluated nebulized ensifentrine in its Phase III clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ensifentrine met the primary endpoint in both ENHANCE-1 and ENHANCE-2 trials demonstrating statistically significant and clinically meaningful improvements in lung function. In addition, ensifentrine significantly reduced the rate and risk of COPD exacerbations in ENHANCE-1 and ENHANCE-2. Two additional formulations of ensifentrine are in Phase II development for the treatment of COPD: dry powder inhaler and pressurized metered-dose inhaler. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

Forward-Looking Statement:

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. 

Company contacts:

Nuance Pharma

Vicky Lin, IR & PR Senior Manager, Email: vicky.lin@nuancepharma.cn

Verona Pharma

Victoria Stewart, Senior Director of Investor Relations and Communications, Email: Victoria.Stewart@veronapharma.com

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SOURCE Nuance Pharma Limited

FAQ

What is the significance of the ENHANCE - China Phase III Trial for VRNA?

The ENHANCE - China Phase III Trial represents a crucial milestone for Verona Pharma as it partners with Nuance Pharma to develop Ensifentrine for COPD.

What were the results of previous trials for Ensifentrine by Verona Pharma?

Ensifentrine met its primary and key secondary endpoints in the Phase III ENHANCE-1 and ENHANCE-2 trials, showing significant improvements in lung function.

When is Verona Pharma expected to submit a New Drug Application for Ensifentrine?

Verona Pharma plans to submit a New Drug Application to the FDA in the second quarter of 2023.

What is Ensifentrine and what conditions is it being developed for?

Ensifentrine is a first-in-class dual inhibitor developed for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

How does Ensifentrine differ from existing COPD treatments?

Ensifentrine combines bronchodilator and anti-inflammatory effects in one compound, differentiating it from current treatment options.