In addition to meeting the primary endpoint, induction of clinical remission at week 6, several secondary endpoints demonstrated statistically significant effects in the 2x250mg dose group compared to placebo (meeting the predefined exploratory type I error rate of p<0.10).
A statistically significantly higher proportion of patients in the highest dose group achieved symptomatic remission compared with placebo. Symptomatic remission means that the patients no longer have blood in their stool and use the toilet a normal number of times per day. This is an important endpoint to achieve for patients, since bloody diarrhea is the primary reason for their low quality of life. In line with this, we also saw a statistically significant higher reduction in the number of daily toilet visits from when patients entered the study to week 6 for patients treated with the highest dose of cobitolimod (2x250mg) compared with placebo.
We observed a numerically higher portion of patients treated with 2x250mg cobitolimod that experienced endoscopic remission compared to placebo, i.e., the patient had a healed colonic mucosa when examined with a camera during a colonoscopy.
Another secondary endpoint where we observed statistically significant differences between the highest dose group (2x250mg cobitolimod) and placebo was when the physician’s assessment of the patient was included in the definition of clinical remission. In addition to the fact that the patient did not have any blood in their stool, went to the toilet a normal number of times per day and had a healed colonic mucosa, the physician’s assessment of the patient’s general condition was significantly approved.
To measure quality of life, patients filled out a standardized form with questions about their quality of life prior to treatment as well as during the course of the study. This questionnaire, called the Inflammatory Bowel Disease Questionnaire (IBDQ), summarize the patient’s answers in an IBDQ score. This endpoint also showed a numerically larger improvement among patients treated with 2x250mg cobitolimod compared with placebo. In the part of the IBDQ that measures social functions, i.e., how the disease affects the patient’s ability to work and participate in activities and social engagements, we saw a statistically significant improvement from when patients entered the study to week 6 for the group that received 2x250mg cobitolimod, compared with placebo.
CONDUCT was an exploratory study designed to have sufficient statistical power to demonstrate a difference between the groups for the primary endpoint: clinical remission at week 6. The study was not designed to have statistical power to detect differences in the secondary endpoints. With that said, we saw a statistically significant effect in the highest dose group in many clinically relevant secondary endpoints. With more patients in phase III, it will be possible to better study the effect of cobitolimod in the secondary endpoints.