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

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

Ensifentrin is a first-in-class dual inhibitor of phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) enzymes combining bronchodilator and anti-inflammatory activities in a single compound. This activity has the potential to relieve respiratory symptoms such as shortness of breath and cough, as well as provide anti-inflammatory benefits for people with COPD.

On August 9e2022, Verona Pharma announced its Phase III ENHANCE-2 trial evaluating the Ensifentrin 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 exacerbations of COPD. Verona Pharma expects to publish top results from its ongoing ENHANCE-1 Phase III trial in late 2022 and, if also positive, plans to submit a New Drug Application to the US Food and Drug Administration. United for ensifentrine in H1H2023.

As part of this Chinese IND approval of Ensifentrine, the completion of Phase I and Phase III studies in China are granted. According to dr. Haijin Meng, marketing director of Nuance Pharma, the company plans to conduct a phase I study to evaluate the detailed pharmacokinetic characteristics of ensifentrin 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 delighted to introduce this first-in-class molecule to China and give our Chinese researchers and subjects the opportunity to participate in the global clinical development of this novel molecule and assess how to properly apply it to the Chinese COPD clinical setting,” she said.

In 2021, Nuance Pharma entered into an agreement with Verona Pharma with a potential value of up to $219 milliongranting Nuance Pharma the exclusive rights to develop and commercialize Ensifentrine in Greater China (continent China, hong kong, Macau and Taiwan). In return, Verona Pharma received an initial payment of $25 million in cash and a stake valued at $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 an important milestone for Nuance Pharma, and we are confident that we will make 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 and over. We are confident that ensifentrine will be an effective COPD treatment to address unmet medical needs in mainland China. China.”

“We are delighted that our development partner, Nuance Pharma, has received IND approval to commence pivotal COPD studies with Ensifentrine on the continent. China,” said David Zaccardelli, Pharma. D., President and CEO 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 in the potential of ensifentrine to address the urgent global need for a new treatment for COPD.

About ensifentrin

Ensifentrin (RPL554) is an investigational, first-in-class dual inhibitor of phosphodiesterase 3 and 4 (“PDE3” and “PDE4”) enzymes that combines bronchodilator and anti-inflammatory activities in a single 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 monotherapy or added to a maintenance bronchodilator. In the Phase 3 ENHANCE-2 clinical trial, ensifentrine showed significant, clinically meaningful improvements in measures of lung function and reduced the rate of COPD exacerbations. Ensifentrine has been well tolerated in clinical trials involving over 2,200 subjects to date.

About Nuance Pharma

Nuance Pharma is a patient-centric, innovation-driven biopharmaceutical company with clinical and commercial-stage assets. Founded by Mark Lotter in 2014, with a mission to meet critical unmet medical needs Greater China and Asia Pacific, Nuance’s portfolio represents a differentiated combination of commercial-stage assets and innovative pipelines in respiratory, pain management, emergency care and iron deficiency anemia. With a focus on specialty care, Nuance is rolling out the Dual Wheel model which incubates an innovative late-stage clinical-stage portfolio, while maintaining a self-sustaining commercial operation.

About Verona Pharma

Verona Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of 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 disease that combines bronchodilator and anti-inflammatory activities in a single compound. The Company is evaluating nebulized ensifentrine in its ENHANCE Phase 3 clinical program (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for the maintenance treatment of COPD. Ensifentrine met the primary endpoint in ENHANCE-2 demonstrating statistically significant and clinically meaningful improvement in lung function. Additionally, 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: the dry powder inhaler (“DPI”) and the pressurized metered-dose inhaler (“pMDI”). Ensifentrin 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 beyond our control, that could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements regarding 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 that may accompany the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances after the date of publication, except as required by law.

contacts

Nuance Pharma

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

Verona Pharma PLC.

Victoria StuartDirector of Investor Relations and Communication, [email protected], Jel: +44 (0)203 283 4200

References

1. Yang, T., Cai, B., Cao, B. et al. REALIZE and improve the management of stable COPD in China: a multicenter, prospective, observational study to realize the current status of patients with COPD 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. Published online September 1, 2019. PMID: 31474120.

3. https://www.cdc.gov/copd/index.htmlaccessed July 2022

4. QuickStats: Percentage of adults aged ≥ 18 years with diagnosed chronic obstructive pulmonary disease, by level of urbanization 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 diseases 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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SOURCE Nuance Pharma Limited

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