Enterprise Therapeutics Publishes Preclinical Profile of a Novel Inhaled ENaC Blocker
Enterprise Therapeutics Ltd recently announced the publication of a peer reviewed study in the Journal of Cystic Fibrosis. The paper describes low doses of the ENaC blocker ETD001, Enterprise’s lead asset, enhancing airway mucus clearance with an exceptionally long duration of action in a sheep model.
This study indicates that ETD001, at a dose level that was well tolerated in healthy volunteer studies, provides an opportunity to test whether a long-acting ENaC blocker can deliver benefit to people with cystic fibrosis (pwCF). ETD001 is scheduled to commence a Phase 2 clinical study in pwCF in summer 2024, to understand whether 28 days of treatment will improve lung function.
Blocking ENaC in the airways offers a novel approach to improve mucus clearance in pwCF, including in the more than 10% of individuals who are either intolerant of or genetically unsuited to CFTR modulators. Recently, several other ENaC blocking drugs (VX-371, AZD5634, BI 1265162, QBW276) failed to show any benefit in clinical trials. This study provides a potential explanation for these failures as data from the sheep model indicate that each may have been dosed in clinical trials at a dose too low to observe an extended duration of action on mucus clearance.
Dr. Henry Danahay, Head of Biology, Enterprise Therapeutics, and lead author of the paper, said “This data provides strong evidence that ETD001 has a superior profile compared to other inhaled ENaC blockers. Along with the results from the Phase 1 trials where ETD001 was well-tolerated, this study supports our high level of confidence going into the Phase 2 clinical trial. We remain passionate in our drive to discover novel therapies that have the potential to transform the lives of all people with cystic fibrosis.”
Enterprise Therapeutics is discovering and developing new therapies that target the underlying mechanisms of mucus congestion in the lungs, one of the main causes of difficulty in breathing and increased risk of infection in respiratory diseases such as cystic fibrosis and COPD. Reducing mucus congestion will reduce the frequency of lung infections and improve patient quality of life. The company’s approach is to increase the hydration and clearance of mucus. Enterprise’s lead asset, ETD001, is a novel inhaled blocker of the epithelial sodium channel (ENaC) with first in class potential. Enterprise has also identified novel targets and compounds that reduce mucus production, an approach that complements mucus hydration therapies. The Enterprise Therapeutics management team has significant expertise in drug discovery, drug development, respiratory biology and ion channel pharmacology. For more information, visit www.enterprisetherapeutics.com.
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