Key Endoscopy Studies That Could Transform Your Practice

Dr David Johnson provides insight on 11 studies from this year's Digestive Disease Week, including pivotal research on endoscopy as well as new data on phase 3 drugs and colorectal cancer screening.

-- TRANSCRIPT --
Hello. I'm Dr David Johnson, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, Virginia.

I've just returned from Digestive Disease Week (DDW) 2024, which was held in Washington, DC.

I've gone through the thousands of plenary and abstract presentations and identified approximately 20 that I find particularly noteworthy. In this three-part series, I'll offer you a brief overview — the 30,000-foot view, if you will — of all the exciting data.
Seladelpar's Promising Efficacy in Liver Disease
Let's begin with new data for the bile acid synthesis suppressant seladelpar, which has shown beneficial effects in liver disease and reducing total bile acid levels.

Investigators behind this ongoing phase 3 international study[1] shared efficacy and safety results for patients with primary biliary cholangitis who had an inadequate response or intolerance to ursodeoxycholic acid. All patients received open-label seladelpar at 10 mg oral daily.

To date, 174 patients have been enrolled and have data available for this interim analysis. Biochemical endpoints included a composite response of alkaline phosphatase (ALP) 1.67 times the upper limit of normal, ALP decrease ≥ 15%, and normalization of total bilirubin.

The primary composite endpoint was achieved in 70.3% of patients and normalization of ALP in 37.2%. The efficacy was outstanding in this population intolerant or nonresponsive to ursodeoxycholic acid, and the safety profile was also excellent.

We'll hopefully see this drug approved in the near future.

An Improved GLP-2 Analog for Short Bowel Syndrome
The glucagon-like peptide (GLP)-2 analog apraglutide was the focus of a study in short bowel syndrome and intestinal failure.[2]

We've had one other GLP-2 analog, teduglutide, approved by the US Food and Drug Administration (FDA), which was back in 2012. The problem with teduglutide is that it required daily injection due to its relatively short half-life of around 3-5 hours. This caused not only a variability in effect but also quality-of-life issues. What's exciting about apraglutide is that the half-life is approximately 72 hours.

In this phase 3, double-blind, randomized controlled trial, once-a-week apraglutide was administered to patients, with a primary endpoint of reduction in parenteral support to meet nutritional or fluid requirements.

Investigators randomized 164 patients at 73 centers in 18 countries. Patients met the primary endpoint with a dramatic effect. Treatment was very safe and effective, and it is likely to become the best in the class due to its once-weekly injection.

Apraglutide was also effective in patients with colon-in-continuity and stoma, which is particularly notable, as the latter population have been shown to be less likely to respond to teduglutide.

We await this drug's approval by the FDA. But this is nonetheless exciting news for the treatment of short bowel syndrome.

Transcript in its entirety can be found by clicking here: