Enterprise Therapeutics continues its Phase 2a trial of ETD001.
Enterprise Therapeutics (Enterprise) has successfully administered ETD001 to an individual with Cystic Fibrosis. The biopharmaceutical company is focused on developing therapies to help improve the lives of those suffering from respiratory disease. Today’s announcement is part of Enterprise’s Phase 2a trial of ETD001.
EDT001 is a low molecular weight compound which Enterprise believes can be used to target the epithelial sodium channel (ENaC) in the airway epithelium and then can work to clear mucus and increase hydration. The aim of Phase 2a of the trial is to deliver clinical proof-of-concept and assess the safety profile of ETD001 in the 10% of pwCF with the highest unmet medical need. Taking place in sites across the UK, Germany, France, and Italy, the study will assess the lung function (FEV1) in pwCF of those who are either ineligible or not receiving CFTR modulators.
An estimated 100,000 are affected by Cystic Fibrosis in the World, with an average life expectancy of 50 years for those suffering. Mucus congestion and the inability to clear mucus lead to a cycle of infection and inflammation with the potential for a decline in lung function.
Dr John Ford, CEO of Enterprise Therapeutics, said: “The dosing of the first person with CF in our Phase 2a trial of ETD001 represents an incredible milestone, a testament to Enterprise’s dedication to advancing a novel approach to treating pwCF with the highest unmet medical need. ETD001 has already demonstrated an excellent safety profile in healthy participants, as well as a pharmacokinetic (PK) profile consistent with a long lung residency. We look forward to progressing ETD001 through Phase 2 trials and beyond.”
Paul Russell, Head of Development at Enterprise Therapeutics, commented: “By targeting the underlying mechanisms of mucus congestion in the lungs through ENaC inhibition, ETD001 has the potential to be a transformative respiratory therapeutic. This is not only for the ~10% of pwCF who are not genetically suited to or do not benefit from CFTR modulators, but also those suffering from other muco-obstructive lung diseases such as COPD and asthma. The commencement of our Phase 2a trial brings us an exciting step closer to realising that potential.”
Dr Renu Gupta, CMO of Enterprise Therapeutics, said: “We are grateful to the pwCF participating in our Phase 2 study of ETD001 and to the clinical investigators for achieving this major milestone. We are hopeful that our steadfast commitment to advancing this innovative ENaC targeting molecule, along with our partnerships with the CF community, will lead to a treatment that will vastly improve the lives of people living with CF.”