FDL176 is an experimental therapy for cystic fibrosis (CF) that is being developed by Flatley Discovery Lab.

How FDL176 works

CF is caused by mutations in the CFTR gene, which provides instructions for making a protein that channels salts in and out of cells. Mutations in CFTR cause the protein to be made incorrectly, meaning that salt is not trafficked normally. This results in the buildup of thick mucus in different organs and tissues.

FDL176 is a CFTR potentiator, a small molecule designed to bind to the CFTR protein and hold the channel open, allowing more salt to move through it.

CF can be treated with a combination of CFTR modulator therapies — two or more medications that work together to address the underlying cause of the disease. The Flatley Discovery Lab is testing FDL176 with FDL169, a CFTR corrector designed to help CFTR fold correctly.

FDL176 in clinical trials for CF

A Phase 1 clinical trial (NCT03173573) to establish the safety, tolerability, and pharmacokinetics (movement in the body) of FDL176 in healthy volunteers and CF patients has been completed. The trial consisted of five parts. The first part was a double-blind, placebo-controlled, dose-escalation study in healthy male volunteers. The second part was a single-dose, open-label study in healthy male participants. The third part was a single-dose, double-blind, placebo-controlled study in healthy female participants. The fourth part was a randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female participants. Finally, the fifth part was a single-dose, open-label study in male and female participants with CF. Although the trial has been completed, the results have not been made public yet.

Another Phase 1 clinical trial (NCT03516331) evaluated the safety and interactions between FDL176 and FDL169. This trial has also been completed, but the results have not been published. A single site in Belfast, U.K., is currently recruiting adults for a similar study in healthy volunteers (NCT03756922).

***

Cystic Fibrosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

 

Emily holds a Ph.D. in Biochemistry from the University of Iowa in 2018 and is currently a postdoctoral scholar at the University of Wisconsin-Madison. She graduated with a Masters in Chemistry from the Georgia Institute of Technology and a Bachelors in Biology and Chemistry from the University of Central Arkansas. Emily is passionate about science communication, and, in her free time, writes and illustrates children’s stories.
×
Emily holds a Ph.D. in Biochemistry from the University of Iowa in 2018 and is currently a postdoctoral scholar at the University of Wisconsin-Madison. She graduated with a Masters in Chemistry from the Georgia Institute of Technology and a Bachelors in Biology and Chemistry from the University of Central Arkansas. Emily is passionate about science communication, and, in her free time, writes and illustrates children’s stories.