November 9, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the United States Patent and Trademark Office (USPTO). The patent provides protection for the use of certain dosage regimens of cobitolimod for treating inflammatory bowel disease, including the 250 mg dose which was successful in the phase IIb study CONDUCT.

The patent, entitled Cobitolimod for use in the treatment of inflammatory bowel disease (patent number 11166975), will provide an exclusivity period until May 2038, with the possibility of up to 5 years term extension after market approval.

“This new patent constitutes a valuable complement to our robust intellectual property portfolio for cobitolimod in the US, which is the most important pharmaceutical market in the world,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “It is a good example of how we continue to file new patent applications in the light of advances in the formulation and clinical development of cobitolimod, to provide exclusivity beyond the term of InDex’s already granted patents.”

Corresponding patent applications have been filed in the strategically most important patent territories globally.

For more information:
Peter Zerhouni, CEO
Phone: +46 8 122 038 50
E-mail: peter.zerhouni@indexpharma.com

Publication
This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 12:25 CET on November 9, 2021.

Cobitolimod in brief
Cobitolimod is a first-in-class 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 met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.

InDex Pharmaceuticals in brief
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.

InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB with email address certifiedadviser@redeye.se and phone number +46 8 121 576 90 is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.