Galectin responds to criticism of results for liver drug in phase 1 trial

Galectin Therapeutics has issued a statement responding to criticism pertaining to the results of its clinical trial of GR-MD-02 in patients with nonalcoholic steatohepatitis and advanced fibrosis.

The company announced results for the second cohort in its phase 1 clinical trial earlier this week and has received negative criticism based on those results on various social media sites, according to a press release. The trial was the first-in-man study and consisted of eight patients being injected with 4 mg/kg GR-MD-02, a galectin inhibitor and complex carbohydrate molecule. Cohort two was assigned twice the dose of the eight patients in cohort one who received 2 mg/kg GR-MD-02, the release said.

“While the results of the clinical trial were positive, the market reacted negatively to this report,” the statement said. “We believe the reaction was fueled in part by certain commentary on social media sites and the Internet, and we strongly disagree with these interpretations of our data. Our goal … is to provide clarity and a helpful framework for investors on the long-term outlook of the company and our work toward developing potential therapies for [nonalcoholic steatohepatitis] and liver fibrosis.”

In a separate release, the law firm of Bronstein, Gewirtz & Grossman announced it has begun investigating Galectin on behalf of purchasers of Galectin securities to determine “whether the company and certain of its executives violated federal securities laws.”

The release said the investigation began after an online article on July 28 alleged that Galectin had hired a stock promotions firm “to tout its stock.” On July 29, Galectin reported phase 1 results of GR-MD-02 showing very little difference from a placebo, the law firm’s release said, and that Galectin’s stock closed down 60.08% that day.

“Certain commentators on social media labeled the second cohort results, ‘a flop,’ this is simply not accurate,” the statement from Galectin said. “The primary endpoints for the phase 1 trial have always been safety and pharmacokinetics and have been successfully met for each cohort completed. The dose of 4 mg/kg was safe and well tolerated and drug levels showed that the drug acted predictably and with a linear increase from the 2 mg/kg dose. While the phase 1 trial is still ongoing, we deem the phase 1 clinical trial a success up to this point.

“This phase 1 clinical trial, and in fact all phase 1 clinical trials, are not designed to demonstrate efficacy of a drug. Phase 2 clinical trials are designed to evaluate efficacy of a drug, and our phase 2 clinical trial(s) will follow the completion of this phase 1 trial.”