The U.S. Patent and Trademark Office (:USPTO) recently issued a Notice of Allowance for the use of Galectin Therapeutics, Inc.’s (GALT) GR-MD-02.
The patent covers both composition and uses of carbohydrate-based galectin inhibitor GR-MD-02 for use in patients with liver fibrosis in combination with other potential therapeutic agents.
GR-MD-02 is currently in phase I development for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis. Spread over a period of four weeks, the trial will evaluate single and multiple doses of GR-MD-02 for evaluating the safety, tolerability and exploratory biomarkers for efficacy.
Galectin Therapeutics has also 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.
Galectin Therapeutics started enrolling patients in the phase I study on GR-MD-02 in Jul 2013. The company expects to report top-line results in early 2014. Data from cohort 2 and cohort 3 should be out in mid-2014. The company might start a phase II study in late 2014 or early 2015 based on phase I study results and expects phase II top-line data in the first half of 2016 depending on the design of the study.
A phase I study is being designed for GR-MD-02 in combination with Bristol-Myers Squibb Co.’s (BMY) Yervoy for the treatment of immunotherapy for metastatic melanoma.
Currently, Galectin Therapeutics carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Lannett Company, Inc. (LCI) and Forest Laboratories Inc. (FRX). Both these stocks carry a Zacks Rank #1 (Strong Buy).