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Jun 30, 2022
Verona Pharma Q2 2022 Earnings Report
Reported positive results from Phase 3 ENHANCE-2 trial and provided a corporate update.
Key Takeaways
Verona Pharma announced positive top-line results from its Phase 3 ENHANCE-2 trial evaluating nebulized ensifentrine for COPD. The trial met its primary and secondary endpoints, demonstrating improvements in lung function and significantly reduced COPD exacerbations. The company expects to submit a New Drug Application to the US FDA in the first half of 2023.
ENHANCE-2 trial met primary endpoint, showing improvements in lung function.
Ensifentrine significantly reduced the rate and risk of COPD exacerbations.
Top-line data from ENHANCE-1 expected around the end of 2022.
NDA submission to the US FDA expected in the first half of 2023, pending positive results from ENHANCE-1.
Verona Pharma
Verona Pharma
Forward Guidance
Verona Pharma anticipates several key milestones in the near term, contingent upon the success of ongoing clinical trials and regulatory processes.
Positive Outlook
- Reporting top-line data from ENHANCE-1 around the end of 2022.
- Potential New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) in the first half of 2023 for inhaled ensifentrine for the maintenance treatment of COPD, conditional upon positive results.
- Positive top-line Phase 3 data from ENHANCE-2 reported in August 2022.
- Successful completion of enrollment in ENHANCE-1 with more than 800 subjects randomized.
- Successful thorough QT analysis demonstrating ensifentrine had no clinically relevant effect on the QT interval or cardiac conduction.
Challenges Ahead
- Russia-Ukraine conflict may impact the company's outsourced clinical research vendor's ability to pay clinical trial sites and investigators in Russia and may impact the vendor's ability to supply ensifentrine and equipment to the sites and validate their trial data.
- The COVID-19 pandemic continues to impact a number of clinical trial activities.
- Sanctions and other restrictions resulting from the Russia-Ukraine conflict and the COVID-19 pandemic may continue to impact clinical trial timelines.
- Potential delays in clinical trial activities due to the Russia-Ukraine conflict.
- Possible disruptions to the supply of ensifentrine and drug-related products, equipment, and services for clinical trials due to the COVID-19 pandemic.