GR-MD-02 is a carbohydrate-based medicine that binds and stops the action of the galectin-3 protein, which is directly involved in multiple inflammatory and fibrotic diseases.
The patent, which will extend until 2032, provides a broad range of proprietary rights associated with the use of GR-MD-02 for compositions, and associated methods of manufacturing compositions capable of treating pulmonary fibrosis.
The patent includes a technique in determining the composition for delivery, via parenteral (such as intravenous or intramuscular injection) or enteral (orally) of the therapy’s active agent — galacto-rhamnogalacturonate — in an acceptable delivery method to a patient with at least primary or secondary lung fibrotic disease in need of the therapy.
The administration is patented in a dose where at least a 5 percent improvement is seen in pulmonary function tests.
“This patent protects our commercial ability to use GR-MD-02 to potentially treat pulmonary fibrosis and is yet another example of the widespread applicability of our galectin-3 inhibitor in treating fibrotic disease,” Harold H. Shlevin, CEO of Galectin Therapeutics, said in a press release.
Pulmonary fibrosis affects a sizable portion of the population and there is a significant need for effective treatment. Animal studies have shown that GR-MD-02 can effectively resolve fibrosis in different tissues and organs, including the liver.
“The company is currently focused on planning and conducting additional supportive work to prepare for a Phase 3 trial for GR-MD-02 in NASH [nonalcoholic steatohepatitis] cirrhosis based on the positive effects of GR-MD-02 on HVPG [hepatic venous pressure gradient] and the possible prevention or postponement of development of esophageal varices in its Phase 2 NASH-CX trial, which we believe is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in these patients,” Shlevin said.
Galectin is a leader in the development of therapeutics that are focused on the treatment of fibrosis and cancers, based on its knowledge of galectin proteins and how they are involved in the mechanisms that drive the development of these diseases.
This particular patent, titled “Method and Treatment of Pulmonary Fibrosis,” was assigned the U.S. Patent Number 9,968,631. The patent application process began in 2016.