The U.S. Patent and Trademark Office has granted Galectin Therapeutics a new patent that extends coverage of its candidate therapy GR-MD-02 to treat systemic sclerosis and other diseases in which high levels of the inducible nitric oxide synthase (or iNOS) enzyme causes inflammation.
“With this patent extending claims to a wide-range of diseases with an inflammatory response, we now have a broad range of patent coverage both for diseases in which we currently have developmental programs, as well as, potential areas of future investigation,” Dr. Peter G. Traber, Galectin’s CEO and chief medical officer, said in a company press release.
Traber added: “Our patent portfolio is an important asset for Galectin Therapeutics. Each patent and patent application is a strategic building block which reflects present and future business objectives and protects current core technology.”
GR-MD-02 specifically inhibit proteins called galectins, which are believed to play a role in several diseases. Galectins are thought to indirectly modulate nitric oxide metabolism, and preclinical studies have shown that this candidate drug can reduce fibrosis and inflammation in animal models of liver fibrosis.
The new patent, which is valid through 2032, will strengthen the already robust patent portfolio of Galectins. The company, headquartered in Norcross, Georgi,a already holds patents on GR-MD-02 composition, production process and several methods of its use for several illnesses. The new patent covers the effect GR-MD-02 has on iNOS enzyme in a range of diseases including systemic sclerosis, autoimmune disease, psoriasis, dermatitis, and cutaneous and systemic lupus erythematosus.
Currently, GR-MD-02 is under clinical development in a Phase 2b trial for NASH cirrhosis (NCT02421094), and Phase 1b trials in combination with Merck’s Keytruda (pembrolizumab) (NCT02575404) and Bristol‑Myers Squibb’s Yervoy (ipilimumab) (NCT02117362) for the treatment of advanced melanoma and other cancers.
The candidate drug has shown promising interim results in two Phase 2a studies in severe skin diseases, such as moderate-to-severe plaque psoriasis (NCT02407041) and atopic dermatitis.