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news.InDex Pharmaceuticals has received a new formulation patent in Europe for the drug candidate cobitolimod which is under assessment for ulcerative colitis.
The ongoing Phase III programme CONCLUDE is designed for treating patients with moderate to severe ulcerative colitis. Credit: CoRus13/ commons.wikimedia.org.
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The company received the patent from the European Patent Office.
The drug is being assessed in the ongoing Phase III programme CONCLUDE for treating patients with moderate to severe ulcerative colitis.
This programme includes two sequential induction studies along with a yearlong maintenance study in patients who have responded to cobitolimod as induction therapy.
The randomised, double-blind, placebo-controlled induction study 1 of CONCLUDE is designed to enrol nearly 440 patients.
Clinical remission at week six is the primary endpoint of the study, which is same as the Phase IIb study CONDUCT.
InDex Pharmaceuticals CEO Jenny Sundqvist said: “It is a key component in our robust patent portfolio for cobitolimod as it specifically protects the intended commercial product and provides broader protection than a method of use patent.”
Patent protection of the enema formulation of cobitolimod will provide an exclusivity period until September 2042.
Upon market approval, there is a possibility of up to five years extension of the patent.
The company has also filed corresponding patent applications in additional strategically important territories worldwide.
In addition, InDex has developed a platform of patent protected discovery stage substances DNA based ImmunoModulatory Sequences (DIMS), for treating several immunological diseases.
