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Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China


SHANGHAI, Aug. 18, 2022 /PRNewswire/ -- Nuance Pharma ("the Company") announces the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal clinical trial of Ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease ("COPD") in mainland China.

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and 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.

On August 9th, 2022, Verona Pharma announced its ENHANCE-2 Phase III trial evaluating nebulized Ensifentrine for the maintenance treatment of COPD met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations. Verona Pharma expects to report top-line results from its ongoing ENHANCE-1 Phase III trial around the end of the 2022 and, if similarly positive, plans to submit a New Drug Application to the US Food and Drug Administration for Ensifentrine in 1H2023.  

Under this Ensifentrine Chinese IND approval, conduction of both Phase I and Phase III studies in China are granted. According to Dr. Haijin Meng, CMO of Nuance Pharma, the company is planning to conduct a Phase I study to evaluate the detailed pharmacokinetic characteristics of Ensifentrine in healthy Chinese volunteers. Meanwhile, the pivotal Phase III study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ensifentrine over 24 weeks in patients with moderate to severe COPD. "We are thrilled to introduce this first-in-class molecule to China and give our Chinese investigators and subjects the opportunity to participate in the global clinical development of this novel molecule and to evaluate how to apply it to Chinese COPD clinical setting properly," she said.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma with a potential value of up to $219 million, granting Nuance Pharma exclusive rights to develop and commercialize Ensifentrine in Greater China (mainland China, Hong Kong, Macau and Taiwan). In return, Verona Pharma received an upfront payment of USD 25 million in cash and an equity interest valued at USD 15 million. Meanwhile, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater China.

"This is a significant milestone for Nuance Pharma, and we are confident that we will achieve solid and inspiring progress for the development of Ensifentrine in China," commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma. "COPD is the fifth leading cause of death in China with a reported prevalence of 8.2% in the population aged 40 years and above. We strongly believe Ensifentrine will be an effective COPD therapy to address the unmet medical needs in mainland China."

"We are pleased our development partner, Nuance Pharma, has received IND approval to begin pivotal studies in COPD with Ensifentrine in mainland China," said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. "This is an important milestone and, based on our recent positive Phase 3 results from our ENHANCE-2 trial in COPD, we remain confident about the potential of Ensifentrine to address the urgent global need for a novel treatment for COPD."

About Ensifentrine

Ensifentrine (RPL554) is an investigational, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") that combines bronchodilator and anti-inflammatory activities in one compound. In Phase 2 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 3 ENHANCE-2 clinical trial, 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 more than 2,200 subjects to date.

About Nuance Pharma

Nuance Pharma is a patient-centric and innovation focused biopharmaceutical company, with both clinical and commercial stage assets. Founded by Mark Lotter in 2014, with the mission to address critical unmet medical needs in Greater China and Asia Pacific, Nuance's portfolio represents a differentiated combination of commercial stage and innovative pipeline assets across respiratory, pain management, emergency care and iron deficiency anemia. Focusing on specialty care, Nuance deploys the Dual Wheel model that incubates a late clinical stage innovative portfolio, while maintaining a self-sustainable commercial operation.

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 is evaluating nebulized ensifentrine in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD thErapy") for COPD maintenance treatment. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, Ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial. Two additional formulations of Ensifentrine are in Phase 2 development for the treatment of COPD: dry powder inhaler ("DPI") and pressurized metered-dose inhaler ("pMDI"). Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.  

Forward-looking statements

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.

Contacts

Nuance Pharma

Vicky Lin, IR & PR Senior Manager, [email protected], Tel: +86 21 3203 5318

Verona Pharma PLC.

Victoria Stewart, Director of Investor Relations and Communications, [email protected], Tel: +44 (0)203 283 4200

References

1.        Yang, T., Cai, B., Cao, B. et al. REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) ? rationale, study design, and protocol. BMC Pulm Med 20, 11 (2020). https://doi.org/10.1186/s12890-019-1000-x

2.        Cazzola M, Calzetta L, Rogliani P, Matera MG. Ensifentrine (RPL554): an investigational PDE3/4 inhibitor for the treatment of COPD. Expert Opin Investig Drugs. 2019 Oct;28(10):827-833. doi: 10.1080/13543784.2019.1661990. Epub 2019 Sep 1. PMID: 31474120.

3.        https://www.cdc.gov/copd/index.html, accessed July 2022

4.        QuickStats: percentage of adults aged ?18 years with diagnosed chronic obstructive pulmonary disease, by urbanization level and age group - National Health Interview Survey, United States, 2019. MMWR Morb Mortal Wkly Rep. 2021 Jul 2;70(26):959.Global Initiative

5.        Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross?sectional study[J]. Lancet, 2018, 391(10131): 1706?1717. DOI: 10.1016/S0140?6736(18)30841?9.

 

SOURCE Nuance Pharma Limited


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