Nuance Pharma Announces Dosing of First Patient in ENHANCE – China Phase 3 Trial for COPD
Verona Pharma plc (Nasdaq: VRNA) has announced that its development partner, Nuance Pharma, has begun dosing participants in the ENHANCE - China Phase 3 trial for ensifentrine, aimed at treating chronic obstructive pulmonary disease (COPD). This milestone follows the clearance of an Investigational New Drug application by the Center of Drug Evaluation in August 2022. Ensifentrine has shown promising results in prior Phase 3 trials, demonstrating significant improvements in lung function and reduced COPD exacerbations. Up to $179 million in milestone payments plus royalties are anticipated from Nuance Pharma's commercialization efforts in Greater China. An NDA for ensifentrine is expected to be submitted to the FDA in Q2 2023, reflecting Verona's commitment to addressing unmet needs in respiratory disease treatment.
- Initiation of ENHANCE - China Phase 3 trial for ensifentrine, expanding market potential.
- Positive Phase 3 results previously recorded for ensifentrine in COPD treatment.
- Potential milestone payments of up to $179 million plus royalties from Nuance Pharma.
- No current FDA approval for ensifentrine, pending NDA submission.
- Market entry dependent on trial outcomes and regulatory approvals, introducing risks.
LONDON and RALEIGH, N.C., April 10, 2023 (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 dosed the first subject in its ENHANCE - China Phase 3 trial for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”).
In August 2022, Nuance Pharma 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 COPD in mainland China. Nuance Pharma initiated a Phase 1 trial with ensifentrine in healthy volunteers in March 2023.
“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 3 results in COPD, we are excited about the potential of ensifentrine to address the urgent global need for a novel therapy for COPD.”
In 2021, Nuance Pharma entered into an agreement with Verona Pharma for exclusive rights to develop and commercialize ensifentrine in Greater China, with future potential milestone payments up to
Further information about these trials can be found at www.clinicaltrials.gov, ENHANCE - China Phase 3 trial (RPL554 - CPC001; NCT05743075), Phase 1 trial (RPL554 - AHC001; NCT05758428).
For further information please contact:
| Verona Pharma plc | US Tel: +1-833-417-0262 UK Tel: +44 (0)203 283 4200 |
| Victoria Stewart, Senior Director of Investor Relations and Communications | IR@veronapharma.com |
| Argot Partners (US Investor Enquiries) | Tel: +1-212-600-1902 verona@argotpartners.com |
| Optimum Strategic Communications (International Media and European Investor Enquiries) | Tel: +44 (0)203 882 9621 verona@optimumcomms.com |
| Mary Clark / Richard Staines / Zoe Bolt |
About Verona Pharma
Verona Pharma is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of chronic 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 3 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 pooled analysis from ENHANCE-1 and ENHANCE-2. Verona Pharma expects to submit a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) in the second quarter of 2023. Two additional formulations of ensifentrine have been evaluated in Phase 2 studies 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 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.
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, planned regulatory submissions and timing thereof, including the timing of submission of an NDA for ensifentrine, the potential for ensifentrine to be the first therapy for the treatment of respiratory diseases to combine bronchodilator and non-steroidal anti-inflammatory benefits in one compound, the potential of ensifentrine to address the urgent global need for a novel therapy for COPD, and the potential of ensifentrine in the treatment of cystic fibrosis, asthma and other respiratory diseases, as well as the potential of the DPI and pMDI formulations of ensifentrine.
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; our need for additional funding to complete development and commercialization of ensifentrine, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; 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 ability to develop or commercialize ensifentrine; we may not be successful in developing ensifentrine for multiple indications; our ability to obtain approval for and commercialize ensifentrine in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, third-party service providers and licensees; our inability to realize the anticipated benefits under licenses granted by us to third parties to develop and commercialize ensifentrine, 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; lawsuits related to patents covering ensifentrine and the potential for our patents to be found invalid or unenforceable; lawsuits related to our licensing of patents and know-how with third parties for the development and commercialization of ensifentrine; changes in our tax rates, unavailability of certain tax credits or reliefs or exposure to additional tax liabilities or assessments could affect our profitability, and audits by tax authorities could result in additional tax payments for prior periods; and our vulnerability to natural disasters, global economic factors, geo-political actions and unexpected events, including health epidemics or pandemics like the COVID-19 pandemic, and conflicts such as the Russia-Ukraine conflict, which has and may continue to adversely impact our business. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and our 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 we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
FAQ
What is the purpose of the ENHANCE - China Phase 3 trial for VRNA?
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