Clinical trials are important research tools to help understand the safety, efficacy, and tolerability of potential treatments. According to a news release from July 19, 2021, biotechnology company Prometheus Biosciences, Inc. (“Prometheus”) recently initiated a Phase 2a clinical trial to evaluate PRA023 for patients with moderate-to-severe ulcerative colitis (UC).
In December 2020, the FDA accepted an Investigational New Drug (IND) application for PRA023 in relation to inflammatory bowel disease (IBD). Later, Prometheus proceeded with a Phase 1a clinical trial evaluating the treatment in healthy volunteers. Within this Phase 2 clinical trial, researchers will now focus on the benefits of the treatment for patients with UC. So far, the first patient has enrolled. Although the company announced the trial initiation, you may need to wait to know more. In fact, more information is going to be shared on July 28, 2021, during R&D Day. Interested in learning more or participating in R&D Day? Register here.
So what exactly is PRA023? According to a prior press release from December 2020, Prometheus describes PRA023 as:
an IgG1 humanized mAb that has been shown to block TL1A. Third-party antibody programs against TL1A have been shown to reduce both intestinal inflammation and fibrosis in preclinical studies.
Ulcerative Colitis (UC)
Ulcerative colitis (UC), a chronic inflammatory disease of the large intestine, exists under the umbrella of IBD. Doctors do not know what causes UC. However, immune malfunction is suspected to play a role. While diet and stress used to be considered causes, they are now considered elements that aggravate UC. Other risk factors include being a young adult (under 30) or older than 60, having a family history of IBD, or having Jewish ancestry. Currently, around 700,000 Americans have UC.
In patients with UC, sores and ulcers form in the large intestine. As symptoms develop over time, patients may not notice until their UC has progressed. Once symptoms appear, they can be debilitating. Symptoms include:
- Nausea and vomiting
- Unintended weight loss
- Bloody stool
- Anemia (low red blood cell count)
- Joint pain
- Abdominal cramping
- Failure to thrive (in children)
- Fecal urgency
A number of complications related to UC may also occur. Thus, it is important to see your doctor if symptoms worsen or you experience a persistent change in bowel habits. Complications include:
- Severe dehydration
- A perforated colon
- Joint, skin, and eye inflammation