MONTREAL, June 26, 2019 — Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a Canadian specialty pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) for Ibsrela™ (tenapanor) has been accepted for review by Health Canada for the treatment of irritable bowel syndrome with constipation (IBS-C). Knight and Ardelyx Inc. (NASDAQ: ARDX) entered into a license agreement in March 2018 granting Knight the exclusive right to commercialize tenapanor in Canada.
Tenapanor is an oral, first-in-class small molecule treatment under review by the FDA for the treatment of irritable bowel syndrome with constipation (IBS-C) and is being evaluated in a second Phase 3 program for the treatment of hyperphosphatemia in patients with end-stage renal disease (“ESRD”) on dialysis.
”We look forward to bringing Ibsrela, a product with established efficacy and safety, to Canadian patients” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “Ibsrela, with its unique mechanism of action, will provide a new treatment option for IBS-C and will further strengthen Knight’s presence in gastroenterology.”
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for the Canadian and select international markets. 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.
Tenapanor is a minimally-systemic small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium transporter NHE3 and reduce sodium absorption in the GI tract, thus increasing intestinal fluid. In addition, data from preclinical studies suggest that tenapanor reduces abdominal pain caused by IBS-C through the inhibition of TRPV-1 dependent signaling. TRPV-1, better known as the “hot chili pepper receptor,” is a well-established pain target known for transmitting painful stimuli from a variety of sources including heat, protons and inflammatory molecules.
Tenapanor is also being evaluated to reduce phosphate absorption and lower elevated serum phosphate concentrations in patients with ESRD on dialysis. A recent discovery by Ardelyx scientists, in collaboration with global academic experts, revealed phosphate absorption in humans occurs primarily through a dynamically regulated paracellular pathway. This pathway of phosphate flux is inhibited by tenapanor in a manner that appears largely specific for phosphate, whereas the overall absorption of other ions and large molecules appear not to be affected. The effect of tenapanor on phosphate absorption is mediated by transiently increasing the intracellular proton concentration in cells lining the gastrointestinal lumen, a result of NHE3 inhibition, which induces a conformational change in tight junction proteins, thereby decreasing permeability to paracellular phosphate transport. Notably, in clinical trials, tenapanor has not affected the absorption of other ions (except sodium) or nutrients. A consequence of intestinal NHE3 inhibition is that systemic sodium absorption is reduced leading to an increase in stool sodium and water content, loosening stool consistency and increasing bowel movement frequency.
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 and in Knight Therapeutics Inc.’s Annual Information Form for the year ended December 31, 2018. 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.
Knight Therapeutics Inc.
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