KNIGHT THERAPEUTICS INC.
IBSRELA™ is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. On
“We are excited to receive approval for this promising new treatment option for patients suffering from IBS-C,” said
About Tenapanor
IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.
Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.
Tenapanor is also being evaluated to reduce phosphate absorption and lower elevated serum phosphate concentrations in patients with chronic kidney disease (CKD) on dialysis. Tenapanor’s unique mechanism of action results in the tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption. Ardelyx reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with CKD on dialysis as well as positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor evaluating the dual mechanism of tenapanor in combination with phosphate binders in patients with CKD on dialysis whose hyperphosphatemia was not controlled with binders alone. Ardelyx is planning to submit their NDA to the FDA in
About Knight
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For further information, please contact:
President
T: 514-678-8930
F: 514-481-4116
info@gudknight.com
www.gudknight.com
Arvind Utchanah
Chief Financial Officer
T. 514.484.4483 ext. 115
F. 514.481.4116
info@gudknight.com
www.gudknight.com
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