Galectin drops 40% on negative NASH result
- Galectin Therapeutics Inc. revealed Tuesday morning that its lead compound for the treatment of non-alcoholic steatohepatitis (NASH) did not meet its primary endpoint in a Phase 2b study.
- The company, however, touted the statistical and clinically meaningful benefit in a subgroup of NASH cirrhosis patients without esophageal varices.
- The biotech’s stock dropped 43% to trade at $1.39 per share in early morning trading on Tuesday. The stock has a 52-week high of $3.68.
It’s rarely ever a positive sign when a biotech has to resort to slicing and dicing data in order to find a positive result. Biotech companies often try to find a sub-population that a drug works in when the drug fails in the overall population. That was the case with Galectin and its NASH drug GR-MD-02.
There were 161 patients in the study, and about 50% of them had NASH cirrhosis without varices. When the company conducted a responder analysis — which only looked at those patients that had a significant reduction in hepatic venous pressure gradient (HVPG) — it found a statistically significant greater percentage of responders among patients without varices who received a 2 mg/kg dosage of GR-MD-02 versus those without varices in the placebo group.
"An indication of NASH cirrhosis without varices would be clinically meaningful to physicians, because it is standard of care for all patients with cirrhosis to have an upper endoscopy to assess for the presence of esophageal varices," said Stephen Harrison, one of lead investigators of the NASH-CX trial and medical director of Pinnacle Clinical Research in San Antonio, Texas.
"Furthermore, we believe that the results stratify a large and easily identifiable group of patients," added Galectin CEO Peter Traber.
Investors weren’t so keen on the distinction. NASH is currently considered one of the hottest areas in clinical development. After the industry found a cure for hepatitis C, the natural next direction for many developers was to explore NASH, a liver disease that has been growing in frequency as the population becomes more obese. The disease is now one of the leading causes of liver transplants, and there is currently no treatment to slow or stop the disease. Yet, the pipeline is filling up with potential compounds, and heavyweights in the space like Gilead Sciences are leading the charge.
- Galectin Therapeutics Statement
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