According to GlobalData’s Clinical Trials Enrollment Database, enrolment rates in IBD trials have been consistently low in the last 10 years, particularly in 2021 and 2022. GlobalData is the parent company of Clinical Trials Arena.
Reasons behind the decline
The authors of the paper, a taskforce composed of experienced IBD clinical researchers from both academia and industry, explored the reasons for the declining rates at four different levels: study design, investigative centre, physician, and patient. The main reasons behind the decreasing enrollment rates were linked to increased demand for trials; high screen failure rates, particularly in Crohn’s disease; and restrictive eligibility criteria.
Lack of dedicated time and training were identified as contributing physician-related factors. The taskforce also concluded that from the patients’ perspective, long wash-out periods and protocol requirements that do not reflect clinical practice limit participation in trials.
Gary Fanger, CEO and president at Rise Therapeutics, says that it is not surprising to hear that the rates of enrolment for IBD trials are decreasing. While the decreasing rates might be linked to better management of the disease, there is still room for disruptive medicine in the IBD space, he adds.
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Targeted patient search
Rise Therapeutics is set to initiate its Phase I trial (NCT05666960) in patients with mild to moderate ulcerative colitis (UC). For this trial, which will begin within a month, Rise selected to work with sites that manage a lot of patients with UC and have a large database of individuals to draw from.
Such an approach was suggested by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) in a meeting summary published in 2021. The paper suggests that the use of electronic healthcare record systems and specialised registries to identify potential patients can facilitate enrollment for IBD clinical studies.
Educating patients by word of mouth or brochures can also help, Fanger says. “We have an information approach that allows patients to become better educated and understand our drug to consider whether they want to go on our trial,” he notes.
Patient-centricity is key. A paper published last year notes that educational tools for physicians and patients might facilitate trial recruitment. Also, there is still a need to simplify language in trial documentation, such as informed consent. Authors of the paper suggest that providing publicly available post-trial information and results may reduce the fear and misunderstanding related to trial participation for participants.
Upcoming trials in UC
Glancing at the IBD pipeline, some sponsors have yet to deal with the ever-increasing challenges of trial recruiting. According to the GlobalData’s Clinical Trial Database, there are 225 planned IBD clinical trials. One of them is sponsored by Rise, studying that company’s investigational therapy R-3750 in an upcoming Phase I trial in UC.
At the end of January, Rise announced that the FDA accepted its investigational new drug (IND) application for the lead program candidate R-3750. R-3750 is an oral immune therapy targeting a microbiome regulatory pathway that engages with immune effectors cells lining the intestinal tract. The US-based Phase I open-label trial will recruit 36 patients with UC, who will receive a daily regimen for 28 days.
Based on the success of the Phase I trial, Rise plans to expand its footprint to Europe with a Phase II trial. The later trial might explore one or two more doses or different dosing regimens in a blinded and placebo-controlled setting.
The Phase II trial would focus on key biomarkers that come out of Phase I as harness points and use the Mayo scoring system, which evaluates the stage of UC, as a primary endpoint. Fanger explains that while these are not approval endpoints, the company will also look at immunological changes, as well as changes that occur in the microbiome. The Phase II trial is likely to start at the beginning of 2025.
While patient recruitment is becoming more challenging, Fanger says that it enables innovative medicine to become more successful. “There are still a lot of really sick patients out there and UC is still a tough disease to manage, regardless of the number of new drugs that we have,” he adds.