Galectin (GALT) Reports Exploratory Phase 2a Pilot Trial of GR-MD-02 in Nash Misses Primary Biomarker Endpoint; Announces $1.5M Private Placement

September 27, 2016 4:14 PM EDT

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Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced topline results from NASH-FX, its Phase 2a clinical trial evaluating the efficacy, safety, and tolerability of GR-MD-02 in 30 nonalcoholic steatohepatitis (NASH) patients with advanced fibrosis. This exploratory, single site, short-treatment (four months of therapy), randomized study 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 (MRE). 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.

Importantly, Galectin simultaneously announced that the principal focus of its research efforts – its larger scale, one-year, multi-site trial in patients with NASH Cirrhosis (NASH-CX) – has completed enrollment one month early with 162 total subjects (exceeding the target of 156 patients), allowing for reporting of top-line results in December 2017. In further contrast to the NASH-FX trial, the NASH-CX trial is being conducted with a primary endpoint (hepatic venous pressure gradient (HVPG)) which the U.S. Food and Drug Administration may view as an acceptable surrogate for outcomes for registration trials in this patient population.

“Although there was no apparent improvement in the three non-invasive tests for assessment of liver fibrosis in this four month pilot trial, inhibition of galectin-3 with GR-MD-02 remains promising for treatment of NASH fibrosis,” said Stephen A. Harrison, M.D., the principal investigator (PI) of the NASH-FX trial, medical director of Pinnacle Clinical Research in San Antonio, TX, and Visiting Professor of Medicine at the University of Oxford, UK. “In regard to the potential activity of GR-MD-02, it is encouraging that there is an important clinical effect in moderate-to-severe psoriasis, suggesting the compound has activity in a human disease that can occur in association with NASH.”

Dr. Harrison, who is also the co-lead PI of the NASH-CX trial, continued, “The NASH-FX trial was designed to follow up on limited data from a Phase 1 study in NASH with advanced fibrosis, which suggested that FibroScan® measurements may have improved with just four doses of drug. However, as we have witnessed in other liver fibrosis trials, the relatively short treatment duration of only 4 months assessed in the NASH-FX was inadequate to see an efficacy response. Therefore, we look forward to additional results from the NASH-CX trial in which patients with NASH cirrhosis are treated for one year.”

Naga Chalasani, M.D., the other co-lead PI of the NASH-CX trial and chief of the Division of Gastroenterology and Hepatology at Indiana University, said, “In my assessment, the results from the NASH-FX trial do not diminish the significance of the NASH-CX trial. Along with the safety and tolerability profile observed in the NASH-FX trial, the different patient population, much larger enrollment, rigorous study design and longer duration of therapy offer compelling rationale to complete the NASH-CX trial.”

With over 1,600 drug doses administered there is now substantial clinical trial experience with GR-MD-02. There is no evidence of serious adverse effects related to the drug, highlighting the good safety profile of the therapy in this patient population with advanced stage disease. In the NASH-CX trial 64 patients have already completed 6 months of dosing with a low drop-out rate of only 3 patients prematurely exiting the trial.

In support for continued funding of the NASH-CX trial, a private placement financing for $1.5 million from a single source was signed on September 22, 2016. “It is encouraging that we have the confidence of a highly-respected businessman such as Mr. Richard Uihlein, who has now invested $1.5 million in Galectin through a limited partnership investment fund, which adds to his current significant stake in the company,” added Peter Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “Mr. Uihlein is further committed to helping the company progress through the completion of the NASH-CX trial. We will continue to pursue the additional funding required to support our clinical development program”.

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