MONTREAL, April 17, 2020 — Knight Therapeutics Inc., (TSX: GUD) (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced that Health Canada has approved IBSRELA™ (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Knight and Ardelyx, Inc. (NASDAQ: ARDX) signed an agreement in March 2018 granting Knight the exclusive right to distribute IBSRELA™ in Canada for IBS-C and hyperphosphatemia.
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 September 12, 2019, the U.S. Food and Drug Administration (FDA) approved IBSRELA™ for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
“We are excited to receive approval for this promising new treatment option for patients suffering from IBS-C,” said Jonathan Ross Goodman, chief executive officer of Knight. “With its unique mechanism of action, IBSRELA™ offers patients a novel, safe and efficacious option for their treatment of IBS-C.”
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 the United States mid-2020 with expected approval in mid-2021.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns a controlling stake in Grupo Biotoscana, a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.’s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company’s web site at www.gud-knight.com or www.sedar.com.
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.’s Annual Report for the year ended December 31, 2019 and in Knight Therapeutics Inc.’s latest Annual Information Form filed on www.sedar.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.
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