Phase 3 (Data)
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Catalyst Info & Data Links
TITLE: Ensifentrine (Nebulized) in COPD - Phase 3 Data
ClinicalTrial.gov (NCT04535986): A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
ClinicalTrial.gov (NCT04542057): A Phase 3 Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
WHAT IS THE CATALYST EVENT?
Phase 3 Data
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
MECHANISM OF ACTION
Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition enables it to combine both bronchodilator and anti-inflammatory effects in one compound. Ensifentrine also activates the Cystic Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is beneficial in reducing mucous viscosity and improving mucociliary clearance. Ensifentrine’s mechanism of action has the potential to alleviate respiratory symptoms such as breathlessness and cough and work against inflammation associated with COPD or inflammation triggered by viruses.
COPD is a progressive and life-threatening respiratory disease without a cure. It is the third leading cause of death globally, according to the World Health Organization. The condition damages the airways and the lungs, leading to debilitating breathlessness that has a devastating impact on performing basic daily activities such as getting out of bed, showering, eating and walking. U.S. sales of medicines used for chronic maintenance therapy of COPD were $9.6 billion in 2019. About 1.2 million U.S. COPD patients on dual/triple inhaled therapy, long-acting beta-agonist (“LABA”)/long-acting muscarinic antagonist (“LAMA”) +/- inhaled corticosteroid (“ICS”) remain uncontrolled, experiencing symptoms that impair quality of life. These patients urgently need better treatments.
Updated by HC
VRNA, Chronic obstructive pulmonary disease (COPD), chronic inflammatory lung disease, Ensifentrine (Nebulized)
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