Galectin Therapeutics gained at Thursday’s open after the pharmaceutical firm engaged a contract research firm to conduct a Phase 2 trial for its the NASH-CX study and submitted a Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA). Shares were up 3.5% at $3.50 in recent trading, in a 52-week range of $3.00 – 18.62.
The company said that it has engaged Pharmaceutical Product Development, LLC (PPD) to conduct the Phase 2 trial with GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with non-alcoholic steatohepatitis (NASH) cirrhosis (the NASH-CX trial). It also submitted the protocol for an SPA to the FDA with the goal of accepting the NASH-CX results, if positive, as one of the trials to support approval of the drug candidate.
“We are very pleased to have finalized our engagement of PPD, one of the leading contract research organizations in the world, and are excited to take this step toward the beginning of our Phase 2 program,” said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. “PPD’s extensive experience in conducting clinical trials in liver-related diseases will serve us well. We are particularly attracted to their work with clinical trial sites possessing familiarity with hepatic venous pressure gradient (HVPG), as the FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. We look forward to the prospect of bringing this new drug to the millions of people in the U.S. with NASH.”
The NASH-CX trial is designed as a multicenter, randomized, placebo-controlled, double-blind, parallel-group study with 156 patients at up to 60 sites to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in NASH patients with cirrhosis.
Enrollment is expected to commence in the second quarter of 2015, and data readout is expected in the fourth quarter of 2017.