Ardelyx (ARDX) Presents IBSRELA Data

Ardelyx, Inc. (Nasdaq: ARDX) today announced that new analyses from IBSRELA Phase 3 trials, T3MPO-1 and T3MPO-2, were presented in three poster presentations at the 2022 Digestive Disease Week Conference (DDW 2022) that is now underway in San Diego, California and virtually.

IBSRELA, discovered, developed and recently launched by Ardelyx, is a first-in-class treatment with a novel mechanism and triple action that is approved by the U.S. Food and Drug Administration (FDA) to treat irritable bowel syndrome with constipation (IBS-C) in adults.

"IBSRELA represents a much-needed novel mechanism approach to treating the many patients who suffer with IBS-C," said Brian E. Lacy, M.D., Ph.D., Professor of Medicine, Mayo Clinic. "I am enthusiastic about having a new therapeutic option, and believe that IBSRELA will make a real difference for many patients."

Ardelyx Poster Presentations:

• Poster #Mo1396, entitled "Long Term Treatment with Tenapanor Improves Abdominal Pain and Other Abdominal Symptoms Associated with IBS-C," summarizes data from a Phase 3 study named T3MPO-2. In this 26-week study, treatment with IBSRELA ameliorated a variety of abdominal symptoms associated with IBS-C, with improvements in abdominal pain, bloating, discomfort, cramping, and fullness observed as early as week 1 and sustained for the entire 26 weeks.
• Poster #Mo1394, entitled "Effect of Tenapanor on Treatment Satisfaction, Degree of Relief, and Quality of Life for Patients with Irritable Bowel Syndrome with Constipation," reviews data from a treatment satisfaction questionnaire completed monthly by patients in the Phase 3 trials, T3MPO-1 and T3MPO-2, where a significantly higher proportion of IBSRELA-treated patients reported adequate relief of IBS-C symptoms versus placebo each week. Treatment with IBSRELA led to greater relief of symptoms, greater treatment satisfaction, and improved quality of life compared with placebo in patients with IBS-C.
• Poster #Tu1375, entitled "Tenapanor has Early Onset of Action in Treating Symptoms of Irritable Bowel Syndrome with Constipation (T3MPO-1 and T3MPO-2 Trials)," presents analyses that evaluated the onset of action for IBSRELA within the first week of treatment in the T3MPO-1 and T3MPO-2 studies. These data demonstrated that IBSRELA provided statistically significant and clinically meaningful improvements in gastrointestinal and pain symptoms compared with placebo in as early as the first week of treatment.

All poster presentations are now publicly available and can be accessed on demand HERE.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
• IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS

Risk of Serious Dehydration in Pediatric Patients

• IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
• Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.

Diarrhea

Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).

INDICATION

IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Please see full Prescribing Information, including Boxed Warning, for additional risk information.

You May Also Be Interested In

• IBM tumbles on soft Q1 revenue; announces HashiCorp $6.4bn acquisition
• Medivir (MVIR) Granted FDA Rare Pediatric Disease Designation and Orphan Drug Designation for MIV-711
• Kiromic BioPharma (KRBP) Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Trial First Three Patients