InDex Pharmaceuticals has reported positive results from the Phase IIb CONDUCT trial evaluating cobitolimod for the treatment of moderate to severe ulcerative colitis.
The dose optimisation study achieved the primary endpoint of clinical remission, demonstrating a superior efficacy of 15% (delta) for patients administered with the highest dose of cobitolimod when compared to placebo.
InDex said that cobitolimod was well tolerated in all dose groups, without any differences in safety profile compared to placebo.
The CONDUCT trial is evaluating the cobitolimod TLR9 agonist, which has a unique mechanism of action.
It included the participation of 213 patients identified with left-sided moderate to severe active ulcerative colitis who did not respond to conventional therapy.
Cobitolimod showed significantly higher clinical remission effect in the study, achieving the primary efficacy measure.
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InDex Pharmaceuticals CEO Peter Zerhouni said: “We are very pleased that the CONDUCT study achieved the main goal of determining the most effective dosage and confirming cobitolimod’s excellent safety profile, which has also been observed in previous clinical studies.
“With an outstanding combination of power and safety, cobitolimod has all the prerequisites to take a leading position in the field. We will now move cobitolimod to Phase III while evaluating the best path to commercialisation.”
Patients administered with a 250mg x 2 dose of cobitolimod showed 21.4% clinical remission, while subjects dosed with 125mg x 4 demonstrated 9.5% remission.
The 125mg x 2 dosed patients showed 4.7% remission, while those administered with the 30mg x 2 dose showed 12.5% remission, compared to 6.8% for placebo.
CONDUCT study principal investigator Raja Atreya said: “Despite existing treatment options, a significant proportion of patients with moderate to severe ulcerative colitis do not respond to available drugs and for which there is a great medical need for new treatment options.”