By Satish Casie Chetty, Clinical Scientist

We’re excited to announce the release of our newest Digital Twin Generator (DTG) for Crohn’s Disease (CD), representing our inaugural move into the inflammation and immunology disease space. Building on our track record of DTGs for neurodegenerative diseases like Alzheimer’s, ALS, Huntington’s, and frontotemporal dementia, this release of the CD DTG 1.0 marks the first step of our expansion into new therapeutic areas.

Crohn’s Disease, first described by Dr. Burrill B. Crohn in 1932, is one of two major Inflammatory Bowel Diseases (IBD)*, the other being ulcerative colitis. CD is a chronic disease causing inflammation and gastrointestinal tract (GI) irritation. While it can affect any part of the GI tract, it most commonly affects the small and large intestines. Nearly one in 100 Americans are diagnosed with IBD, and the prevalence of CD in Northern America in 2023 is an estimated two million cases.

The onset of CD can occur at any age, but it is most commonly diagnosed in adolescents and adults between 20-30. The persistent inflammation of the GI tract leads to symptoms such as abdominal cramps and pain, rectal bleeding, frequent diarrhea, and urgency to move bowels. Patients may experience fluctuations in the presentation of these symptoms—flares or periods of active symptoms, which may be followed by remission when symptoms are absent. Without proper management of symptoms, patients with Crohn’s Disease experience a poor quality of life.

Several drug classes have been developed to combat CD and keep patients in remission. However, an estimated 30-40% of patients do not respond to existing therapies or experience relapses, so there continue to be unmet medical needs in IBD. Consequently, the number of CD trials has steadily increased, but patient recruitment is a major obstacle. Between 1998 and 2018, the average recruitment rate in clinical trials for CD decreased from 0.65 to 0.1 patients per site per month. The difficulty in achieving enrollment targets and the subsequent failure of trials to reach completion impact patients, clinicians, and industry sponsors. Patient recruitment is one of the most urgent challenges to keep CD trials moving forward.

Enter our CD DTG 1.0 into the clinical trial arena. Our state-of-the-art DTG can forecast key endpoints frequently used in CD clinical trials, including the short Crohn’s Disease Activity Index and the Simple Endoscopic Score for CD. The main advantage? Our European Medicines Agency-qualified method combining AI and novel statistical methods reduces the number of participants required to achieve a given statistical power in a clinical trial. This technology is a game-changer in the context of CD trials, where patient recruitment has been the most salient barrier to the successful completion of trials in recent years.

For more detailed information on our CD DTG 1.0, including training data, a full list of endpoints, and performance metrics, see our CD DTG 1.0 specification sheet on our website.

We are confident that adopting this technology will significantly impact the CD trial space by speeding up the development of new drugs. Looking into the future, we aim to expand our coverage of IBD by developing a DTG for ulcerative colitis, aiming to improve the lives of patients suffering from this debilitating group of diseases.

*Note: IBD should not be confused with Irritable Bowel Syndrome (IBS).