3030-401-002 ELX BAM Study

Inclusion Criteria:

- Adult men or women aged 18 to 65 years inclusive with a diagnosis of IBS-D per Rome IV
criteria.

- Participants with evidence of BAM must have a fasting serum
7a-hydroxy-4-cholesten-3-one (7αC4) level ≥ 52.5 ng/mL or total fecal bile acid (BA) >
2337 micromoles/48 hours (positive result) at screening or within 1 calendar year
prior to screening.

- Participants without BAM must have a fasting serum 7αC4 level ≤ 47.1 ng/mL or total
fecal BA < 2200 micromoles/48 hours (negative result) at screening or within 1
calendar year prior to screening.

- Has an average daily Bristol Stool Form Scale (BSFS) score ≥ 5.0 or ≥ 25% of diary
entry days with a BSFS score of 6 or 7 during the 14 days prior to Day 1.

- Women of childbearing potential must use hormonal or double barrier contraception or
maintain a monogamous relationship with a vasectomized male partner from the date of
informed consent until 24 hours after final dose of study drug.

- Completed the electronic diary (eDiary) on ≥ 10 of the 14 days prior to Day 1.

- Has not used loperamide rescue medication on > 3 of the 14 days prior to Day 1.

Exclusion Criteria:

- Has a diagnosis of IBS with a subtype of irritable bowel syndrome with constipation
(IBS-C), mixed IBS, or unsubtyped IBS per Rome IV criteria.

- Does not have a gallbladder.

- Has known or suspected biliary duct obstruction, or sphincter of Oddi disease or
dysfunction. (Participants with a history of gallstones may be enrolled).

- Has a history of alcoholism, alcohol abuse or alcohol addiction, or drinks more than 3
alcoholic beverages per day.

- Has a history of pancreatitis; structural diseases of the pancreas, including known or
suspected pancreatic duct obstruction.

- Has a history of mild, moderate, or severe hepatic impairment according to Child-Pugh
classification. History or current diagnosis of inflammatory or immune-mediated
gastrointestinal (GI) disorders.

- Has Celiac disease or a positive serological test for celiac disease.

- Has known lactose or fructose intolerance associated with diarrhea, abdominal pain or
discomfort, that could confound assessments in the study.

- Women who are currently pregnant or nursing, or plan to become pregnant or nurse
during the study.

- Has known allergies or hypersensitivity to opioids.