2023-03-16 09:09:42 ET
- Galectin Therapeutics ( NASDAQ: GALT ) said a data and safety monitoring board (DSMB) gave greenlight to continue a phase 2b/3 trial of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH).
- The DSMB decision to continue the phase 2b/3 trial, dubbed NAVIGATE, without modifications was based on review of data collected so far, on the tolerance and safety profile of the drug, according to the company.
- Galectin added that it was the third independent DSMB meeting.
- "The study is now fully randomized, and we are continuing to collect a large amount of safety data. This third recommendation further strengthens our confidence that belapectin will offer a beneficial risk-benefit profile," said Galectin's Chief Medical Officer Pol Boudes.
- The main efficacy goal of the study, which randomized 357 patients in 14 countries, is the primary prevention of esophageal varices.
- Galectin expects interim topline data from the phase 2b of the trial in Q4 2024.
- GALT -1.58% to $1.87 premarket March 16
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Galectin gets safety board nod to continue trial of liver disease drug belapectin