Phase III MASH Miss Sends Galectin Stock Tumbling

Galectin’s shares tanked in premarket trading Friday after the biotech revealed its lead asset missed the primary endpoint for its Phase IIb/III trial for patients with a type of liver cirrhosis.

Galectin Therapeutics’ stock is down over 35% in premarket trading Friday morning after its lead asset failed to reach its primary endpoint for patients with a form of liver cirrhosis.

The Georgia-based biotech designed its Phase IIb/III trial for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and high blood pressure in the portal vein. The NAVIGATE trial’s primary endpoint was the prevention of varices—enlarged veins in the esophagus that may occur in people with cirrhosis of the liver. Belapectin in both 2 mg/kg and 4 mg/kg doses did reduce the incidence of varices in the intent-to-treat population, but the difference over placebo was not statistically significant.

Galectin touted the per-protocol population—those who completed 18 months of therapy with upper endoscopy at start and finish—in which the incidence of varices was reduced by 48.9%, still short of the targeted 52.5% reduction.

The safety profile of the drug remains “highly encouraging,” according to the company, with adverse events and discontinuation rates across both dosage groups comparable to placebo. As a sugar-like structure, the drug has low toxicity potential because it is metabolized to relatively harmless compounds, according to the company.

Belapectin blocks the action of galectin-3, a protein that plays a role in inflammation, cell growth and fibrosis. In a Phase I study, belapectin combined with Keytruda showed a 50% response rate in advanced melanoma.

Naga Chalasani, a professor at Indiana University School of Medicine who has been involved in the development of belapectin, said in a statement that the drug “clearly is offering a reproducible benefit and should be continued in clinical development.”

Investors are less convinced as they sent the share price tumbling sharply from its starting point of $2 on Friday morning before the markets opened.

Galectin is continuing to analyze the trial data and waiting on 36-month outcomes, which should be available in early 2025. Once that’s in hand, the company will determine next steps.

https://www.biospace.com/drug-development/phase-iii-mash-miss-sends-galectin-stock-tumbling