Share price of Galectin Therapeutics (GALT) jumped 12.9% after the company announced dosing of the first patient in cohort 2 of a phase I study on GR-MD-02. The candidate is being evaluated in a phase I study for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis. NASH is also known as fatty liver disease.
As per information provided by the company, NASH is expected to affect 9 million to 15 million people in the U.S.
The patient was dosed with 4 mg/kg of GR-MD-02, which is twice the dose given in cohort 1. In the first cohort, GR-MD-02 was found to be safe and well tolerated at 2 mg/kg with no drug related adverse events. The cohort 1 showed significant improvement in multiple biomarkers of fibrosis and liver inflammation in patients with NASH with advanced fibrosis.
The positive results from cohort 1 have led to the enrollment of patients in the second cohort. Result from cohort 2 is expected at the end of July this year.
Galectin Therapeutics has obtained Fast Track designation from the U.S. Food and Drug Administration (:FDA) for the development of GR-MD-02 in Aug 2013 for the treatment of NASH with advanced fibrosis.
GR-MD-02 is also in a phase Ib study, in combination with Bristol-Myers Squibb Co.’s (BMY) Yervoy for the treatment of immunotherapy for metastatic melanoma. GR-MD-02 is in its preclinical development for the treatment of lung fibrosis and kidney fibrosis.
Galectin Therapeutics carries a Zacks Rank #3 (Hold). Some stocks that are better placed include Salix Pharmaceuticals Ltd. (SLXP) and Enanta Pharmaceuticals, Inc. (ENTA). Both carry a Zacks Rank #1 (Strong Buy).