InDex Pharmaceuticals Gets New Patent in the U.S.

Thursday, October 12, 2017

InDex Pharmaceuticals Holding AB (publ) announced that a new method of use patent for the drug candidate cobitolimod will be issued by the United States Patent and Trademark Office (USPTO). The patent provides additional protection for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy, wherein cobitolimod is not administered in combination with corticosteroid or glucocorticosteroid.

The continuation patent, entitled Method for prevention of colectomy (patent number 9795627), will provide an exclusivity period until November 2032, with the possibility of up to 5 years term extension after market approval.

"This new patent constitutes a valuable complement to our existing portfolio of granted patents for cobitolimod in the US," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "The patent covers the use of cobitolimod for treatment of ulcerative colitis in patients with or without a history of steroid use when cobitolimod is not administered in combination with steroids, and it is not limited to certain dosing regimens of cobitolimod."

The USPTO has notified the company that the patent will be issued on October 24, 2017. Corresponding patent applications have been or will be filed in Europe, Japan and Canada and will be diligently prosecuted to grant.

Cobitolimod in brief

Cobitolimod is a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. It is a so-called Toll-like receptor 9 (TLR9) agonist, that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively. Cobitolimod is also known as Kappaproct® and DIMS0150.

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