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2022.08.16

August 16th, 2022, Nuance Pharma announces IND approval from the Center for Drug Evaluation (CDE) for supporting its pivotal clinical trials of Ensifentrine in the treatment of chronic obstructive pulmonary disease (COPD) in China.


Ensifentrine, a phosphodiesterase protein dual MOAs (PDE3 / PDE4) inhibitor, has the potential to alleviate respiratory symptoms such as breathlessness and cough, and works against inflammation associated with COPD or inflammation triggered by viruses.


On August 9th, 2022, Verona Pharma announced that one of its Ensifentrine pivotal phase III studies, ENHANCE-2 trial for COPD, met its primary and secondary endpoints. Simutaneously, two phase III clinical trials (NCT04542057, NCT04535986) for COPD were launched in September 2020, and Verona Pharma plans to file NDA for Ensifentrine in 2023 H1 to FDA providing the ENHANCE-1 trial also reports positive results.


Ensifentrine study in China


In China, COPD ranks the 3rdchronic disease, with about 100 million patients. According to the China Pulmonary Health [CPH] study conducted in 2018, COPD has the prevalence of 8.6% for population aged more than 20 years and 13.7% for adults aged over 40 years. The standard treatments are limited to 3 MOAs such as LAMA, LABA and ICS. 


While clinical evidence has shown decline in exacerbation rate and improvement in quality of life for the Chinese patients, the current treatments have limited impacts on exacerbation delay or mortality improvements, signaling huge unmet needs for more effective COPD treatments in China. Ensifentrine may well be the novel First in Class solution to the Chinese patients.



Under this Ensifentrine Chinese IND, conduction of both phase I and phase III stidies in China are approved.


  • RPL554-AHC001 is a phase I, open-label, single and multiple dose study to evaluate the pharmacokinetics, safety and tolerability of nebulized Ensifentrine in healthy Chinese subjects.


  • RPL554-CPC001 is a phase III, 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.


According to Dr. Haijin Meng, CMO of Nuance Pharma, “We are trilled to introduce this FIC molecule to China hoping that our Chinese investigators and subjects have the opportunity to participate in the clinical development of this novel molecule and evaluate how to apply it to the Chinese COPD clinical setting properly. ”


In June 2021, Nuance Pharma entered into an agreement with Verona Pharma for the exclusive rights to develop and commercialize Ensifentrine in Greater China (including Hong Kong, Macau and Taiwan).



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. For more information, 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.


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. 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.


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