Verona Pharma Launches Ohtuvayre for COPD and Advances Pipeline
Key Insights
Verona Pharma's Ohtuvayre (search) (ensifentrine) is now available in the U.S. for chronic obstructive pulmonary disease (COPD (search)) maintenance treatment, marking a novel inhaled option.
The company plans to initiate Phase 2 trials for a fixed-dose combination of ensifentrine and glycopyrrolate, and for nebulized ensifentrine in non-cystic fibrosis bronchiectasis (search) in Q3 2024.
Early launch data shows positive healthcare provider response, with over 100 HCPs prescribing Ohtuvayre (search) shortly after launch, indicating strong initial interest.
Verona Pharma plc has announced the commercial availability of Ohtuvayre (search)™ (ensifentrine) in the United States for the maintenance treatment of chronic obstructive pulmonary disease (COPD (search)) in adults. This marks the first novel inhaled product for COPD in over 20 years, offering both bronchodilator and non-steroidal anti-inflammatory activities.
Ohtuvayre Launch and Early Adoption
According to Verona Pharma's President and CEO, David Zaccardelli, healthcare professionals and patients are enthusiastic about Ohtuvayre (search)'s potential to alleviate COPD (search) symptoms. The company's field sales force has already engaged with over 2,000 healthcare providers, with more than 100 unique prescribers adopting Ohtuvayre through a specialty pharmacy network.
Expanding the Ensifentrine Pipeline
Verona Pharma is also advancing its pipeline with two Phase 2 clinical trials planned for the third quarter of 2024:
- Fixed-Dose Combination: An investigational new drug application (IND) has been submitted to the FDA for a fixed-dose combination of ensifentrine and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), to be delivered via nebulizer for COPD maintenance. A Phase 2 dose-ranging trial is expected to begin in Q3 2024.
- Non-Cystic Fibrosis Bronchiectasis (NCFBE): A Phase 2 trial will assess the efficacy and safety of nebulized ensifentrine in patients with NCFBE. This randomized, double-blind, placebo-controlled trial will enroll 180 patients with a history of pulmonary exacerbation, evaluating the effect of 3mg of ensifentrine twice daily on exacerbation rates, symptoms, and quality of life.
Financial Position
Verona Pharma's financial results for the second quarter of 2024 show a strong cash position of $404.6 million as of June 30, 2024. This includes $70 million drawn under a debt facility and $100 million under a revenue interest purchase and sales agreement (RIPSA). The company believes its current cash and access to additional funding will support operations and capital expenditures beyond 2026, including the commercial launch of Ohtuvayre (search).
Upcoming Presentations
Verona Pharma plans to present further analyses from the Phase 3 ENHANCE trials at the European Respiratory Society International Congress 2024 and the CHEST Annual Meeting 2024.