Ensifentrine
Ensifentrine's unique mechanism of action has the potential to have a major impact on the treatment of respiratory diseases.
Key activities
Ensifentrine is an investigational drug under review by the US Food and Drug Administration (FDA) and it has not been evaluated as safe or effective or approved for commercialization.
The novel compound combines bronchodilator and non-steroidal anti-inflammatory activities in one compound.
Ensifentrine has been well tolerated in clinical trials involving approximately 3,000 subjects. It is designed to maximize its effectiveness and reduce adverse events through:
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high dual selectivity of phosphodiesterases 3 and 4 (PDE3 and PDE4) over other enzymes and receptors to minimize off-target effects;
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direct delivery to the lungs by inhalation to maximize pulmonary exposure to ensifentrine while minimizing systemic distribution and potential adverse events.
Unique mechanism of action
Meet Ensifentrine
Ensifentrine is a first-in-class, inhaled, dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes. This selective dual inhibition enables the inhaled therapy to combine bronchodilator and non-steroidal anti-inflammatory properties in one compound, differentiating it from existing drug classes used to treat COPD, including corticosteroids, beta2-agonists and anti-muscarinics.
Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. This potentially makes it an attractive therapy for the treatment of cystic fibrosis.
Product Pipeline
Ensifentrine is under review by the FDA and its efficacy and safety has not been established by any regulatory agency.
In the third quarter of 2023, the US FDA accepted for review the Company’s New Drug Application seeking approval of nebulized ensifentrine for the maintenance treatment of patients with COPD and assigned a PDUFA target action date of June 26, 2024.
This followed the successful completion of our Phase 3 trial program ENHANCE (Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) in this indication. 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 substantially reduced the rate and risk of COPD exacerbations in pooled analysis from ENHANCE-1 and ENHANCE-2.
We have reported positive Phase 2 results with DPI and pMDI formulations of ensifentrine demonstrating significant improvements in lung function in COPD patients. Ensifentrine also has potential applications in cystic fibrosis, asthma and other respiratory diseases.
Indication & Formulation
Preclinical
Phase 1
Phase 2
Phase 3
US FDA Review
Verona Pharma
Investor Information
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