Galectin tanks as NASH drug candidate fails in study of patients with advanced fibrosis

Shares of Galectin Therapeutics (Nasdaq: GALT) plunged nearly 47% to $1.32 after the company reported disappointing results from a mid-stage study of its candidate compound for the treatment non-alcoholic steatohepatitis (NASH) patients.

Top-line results from NASH-FX, its Phase IIa clinical trial evaluating the efficacy, safety, and tolerability of GR-MD-02 in 30 non-alcoholic steatohepatitis (NASH) patients with advanced fibrosis, showed it did not meet its primary biomarker endpoint as measured by LiverMultiscan (LMS, Perspectum Diagnostics), a magnetic resonance imaging test that evaluates inflammation and fibrosis.

The trial also did not meet secondary endpoints that measure liver stiffness as a surrogate for fibrosis, with FibroScan and magnetic resonance elastography. While all patients had a baseline liver biopsy to establish the diagnosis and fibrosis severity, liver biopsies were not performed at the end of the study following treatment due to safety considerations involved with liver biopsy-related risk in a short duration trial. GR-MD-02 was found to be safe and well tolerated among the patient population with no serious adverse events.