InDex Pharmaceuticals will be granted a U.S. patent covering the use of certain dosage regimens of its investigational drug Kappaproct (cobitolimod) for the treatment of moderate-to-severe active ulcerative colitis (UC) in patients not responding to available therapies.
The United States Patent and Trademark Office will issue the patent called “Method for prevention of colestomy” (number 9492516) on Nov. 15, granting InDex with exclusivity until November 2032, with up to 5 years extension following Kappaproct’s market approval.
“This patent further strengthens and extends our intellectual property position for cobitolimod in the U.S., which is the most important pharmaceutical market in the world,” Peter Zerhouni, CEO of InDex Pharmaceuticals, said in a press release. “We are pleased that the USPTO confirms that cobitolimod is a unique and innovative asset for the treatment of refractory ulcerative colitis,” he said.
In addition to the U.S., InDex also has filed patent applications for Kappaproct in Canada, Europe and Japan.
Cobitolimod is a first-in-class toll-like receptor 9 agonist that mimics microbial DNA through immunomodulation. The drug, in late-stage clinical development, provides local anti-inflammatory relief by healing the colonic mucosa.
In COLLECT (NCT01493960), a placebo-controlled, double-blind, randomized Phase 3 study, Kappaproct was evaluated in terms of its efficacy and safety in 131 patients with chronic active UC not responding to available therapy.
Patients were treated with either 30 mg of Kappaproct or a placebo in two separate rectal doses at the beginning of the study and at week four. The results of this study,“Clinical effects of a topically applied Toll- receptor 9 agonist in active moderate to severe ulcerative colitis,” recently published in the Journal of Crohn’s and Colitis (JCC), showed that at week four, a higher proportion of patients treated with the drug compared to placebo achieved symptomatic remission was 32.1% vs. 14%, respectively. At week eight, the proportion was 44.4% vs. 27.9%, respectively.
At week four, more patients on Kappaproct compared to placebo had mucosal healing (34.6% vs. 18.6%) and histological improvement in the Geboes score, an assessment of UC disease activity, (30.9% vs. 9.3%).
In addition, more patients on Kappaproct compared to placebo were in clinical remission with mucosal healing (21% vs. 4.7%, respectively). The drug was found to be well-tolerated with no safety concerns observed during the study.
Based on the promising data, InDex is planning to conduct a phase 2b dose-finding clinical trial of Kappaproct to optimize its dose regimen in patients with moderate-to-severe active UC. In March, the U.S. FDA cleared InDex’s investigational new drug application and the trial design.