Nuance Pharma receives Clearance to begin Pivotal Clinical Trials with Ensifentrine for COPD in China

Rhea-AI Summary

Verona Pharma plc (Nasdaq: VRNA) announced that its development partner, Nuance Pharma, received IND approval from the Center of Drug Evaluation to initiate Phase 1 and Phase 3 studies for ensifentrine, targeting COPD treatment in mainland China. This follows a $219 million agreement from 2021, which included a $25 million upfront payment and future milestone payments. The ENHANCE-2 trial showed significant improvements in lung function with ensifentrine, indicating promising potential in addressing COPD.

Positive

• Nuance Pharma received IND approval for ensifentrine's clinical studies in mainland China.
• Verona Pharma's agreement with Nuance has a potential value of $219 million, enhancing financial stability.
• Recent Phase 3 results from the ENHANCE-2 trial demonstrated significant lung function improvement.

Negative

• Clinical trials may face delays or complications as highlighted in the risk factors.
• Dependency on the success of ensifentrine could impact Verona's future if results are not favorable.

LONDON and RALEIGH, N.C., Aug. 19, 2022 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its development partner, Nuance Pharma, has received clearance from the Center of Drug Evaluation (“CDE”) for its Investigational New Drug (“IND”) application to conduct both Phase 1 and Phase 3 studies with ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”) in mainland China.

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 $25 million in cash and an equity interest valued at $15 million in Nuance Biotech, the parent company of Nuance Pharma. In addition, Verona Pharma is eligible to receive future milestone payments as well as double-digit royalties as a percentage of net sales in Greater 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.”

For further information please contact:

Verona Pharma plc	US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200
Victoria Stewart, Director of Investor Relations and Communications	info@veronapharma.com
Argot Partners (US Investor Enquiries)	Tel: +1-212-600-1902 verona@argotpartners.com
Kimberly Minarovich / Michael Barron
Optimum Strategic Communications (International Media and European Investor Enquiries)	Tel: +44 (0)203 882 9621 verona@optimumcomms.com
Mary Clark / Rebecca Noonan / Zoe Bolt

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 has potential applications in cystic fibrosis, asthma and other respiratory diseases. For more information, please visit www.veronapharma.com.

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.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding milestone payments, royalties and other financial terms of the collaboration agreement with Nuance Pharma, the timing of Nuance Pharma beginning clinical studies for the treatment of COPD in China, and the potential of ensifentrine in the treatment of COPD, cystic fibrosis, asthma and other respiratory diseases.

These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from our expectations expressed or implied by the forward-looking statements including, but not limited to, the following: our limited operating history; the reliance of our business on the success of ensifentrine, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with ensifentrine, which could adversely affect our ENHANCE Phase 3 program or our ability to develop or commercialize ensifentrine; potential delays in enrolling patients, which could adversely affect our or Nuance Pharma’s research and development efforts and the completion of our or Nuance Pharma’s clinical trials; we may not be successful in developing ensifentrine for multiple indications; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers or development partners; our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel; material differences between our “top-line” data and final data; our reliance on third parties, including clinical research organizations, clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize ensifentrine; and lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; and our vulnerability to natural disasters, global economic and geo-political factors and other unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in Verona Pharma’s Annual Report on Form 10-K filed with the SEC on March 3, 2022, and Verona Pharma’s other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause the Company’s views to change. These forward-looking statements should not be relied upon as representing Verona Pharma’s views as of any date subsequent to the date of this press release.

 

FAQ

What recent development did Verona Pharma announce regarding ensifentrine?

Verona Pharma announced that Nuance Pharma received IND approval to conduct Phase 1 and Phase 3 studies for ensifentrine for COPD in mainland China.

What is the significance of the IND approval for ensifentrine in China?

The IND approval is crucial as it allows for pivotal studies to commence, potentially leading to new treatment options for COPD patients.

What were the results of the recent ENHANCE-2 trial for ensifentrine?

The ENHANCE-2 trial demonstrated significant and clinically meaningful improvements in lung function.

What financial benefits could Verona Pharma see from its deal with Nuance Pharma?

Verona Pharma could receive milestone payments and double-digit royalties as a percentage of net sales in Greater China.

What are the next steps for ensifentrine after the IND approval?

The next steps include initiating the Phase 1 and Phase 3 clinical studies in mainland China for COPD.