Galectin Therapeutics’ stock has halved since the company revealed its investigational drug failed to significantly reduce enlarged veins for people with liver scarring.
Since the biotech shared the phase 3 data this morning, the company’s stock has dropped 54%, from $2 per share to 92 cents.
The data center around belapectin, a new chemical entity designed to target extracellular galectins, which are carbohydrate-binding proteins involved in many bodily functions. Galectin tested the candidate out in a late-stage trial, dubbed NAVIGATE, that enrolled 355 patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.
Patients were randomized to one of three groups: In one arm, individuals received 2 mg of belapectin for each kilogram of lean body mass; another cohort of patients received 4 mg belapectin per kilogram; and the last arm received placebo. All received their assigned treatment every other week for 18 months.
The trial’s primary endpoint was preventing varices, which are swollen veins in the esophagus. Galectin measured the endpoint as a combined clinical outcome that included patients with any varices, those with intercurrent events, or patients without an endoscopy or intercurrent events at 18 months.
While Galectin found that esophageal varices incidence dropped for patients in both the 2-mg/kg and 4-mg/kg groups, the composite endpoint failed to hit statistical significance.
“I am encouraged by the results demonstrating an approximately 49% reduction in the development of varices in patients with MASH cirrhosis with the previously studied belapectin dose of 2 mg in such a large, global trial,” Naim Alkhouri, M.D., chief medical officer and director of the steatotic liver program at Arizona Liver Health, said in a Dec. 20 release. “I believe the results warrant further clinical development as belapectin could become a pivotal therapeutic option for these patients that currently do not have any treatment options.”
Belapectin was overall well tolerated, with a similar rate of adverse events and serious adverse events across treatment and placebo groups, according to Galectin.
“All enrolled subjects transitioned into a 36-month treatment period, with approximately 50 subjects completing the full 36 months to date,” Galectin Chief Medical Officer Khurram Jamil, M.D., said in the release. “We are still analyzing the extensive data from the trial and anticipate providing multiple clinical updates from the subjects completing 36-month therapy, as well as additional biomarker data in Q1 2025.”
The company plans to speak with potential pharma partners and medical experts to figure out the next steps for the investigational drug, Galectin CEO Joel Lewis said in the release.