InDex Pharmaceuticals has announced the conclusions from in-depth analysis of the complete data set from the phase IIb dose optimisation study CONDUCT, evaluating the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis.

The analysis confirms that the highest dose tested, which met the primary endpoint of the study, demonstrates an outstanding combination of efficacy and safety.

“A significant number of patients with moderate to severe ulcerative colitis do not respond to or cannot tolerate available medical therapies, resulting in a high unmet medical need. With the convincing results seen in patients with left-sided ulcerative colitis in the CONDUCT study, together with the novel and unique mechanism of action, I believe that cobitolimod has great potential as a future treatment alternative,” said Professor Walter Reinisch from the Medical University of Vienna and Medical Advisor in the CONDUCT study. “I look forward to the further development of cobitolimod.”

“Following in-depth analysis of the complete data set with the help of key opinion leaders, we can conclude that the CONDUCT study fulfilled its objectives in both the primary and a number of clinically relevant secondary endpoints. The robustness and consistency of the CONDUCT results support InDex’s strategy to move cobitolimod forward in development and our phase III preparations are continuing according to plan,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “Once ongoing regulatory discussions have been completed, we will be able to finalise the phase III design. Our plan is to be ready to enrol patients in the second half of this year. With its outstanding combination of efficacy and safety, we see great potential for cobitolimod to take a significant share of the large and growing market for moderate to severe ulcerative colitis.”

Photo of Peter Zerhouni, CEO of InDex Pharmaceuticals