Knight Therapeutics Inc. (TSX: GUD), ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today the Canadian commercial availability of IBSRELA (tenapanor), a first-in-class therapy for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Knight has the exclusive right to commercialize IBSRELA in Canada under the terms of a license agreement entered into with Ardelyx, Inc. (NASDAQ: ARDX) in March 2018, which license agreement also provides Knight with exclusive rights to commercialize tenapanor for hyperphosphatemia in Canada. IBSRELA was approved by Health Canada on April 15, 2020 and is now covered by most private insurance companies in Canada.
IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract with a novel mechanism of action centered on reducing absorption of sodium from the small intestine and colon, 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 IBS-C in adults. In the clinical development of IBSRELA diarrhea was the most common adverse event reported by patients often occurring during the first week of treatment.
"Even with the current therapeutic options, many patients suffering from constipation predominant irritable bowel syndrome remain dissatisfied with the current treatments available. Hence, new therapeutic options for treating this challenging condition are needed", according to Dr. Louis Liu, Chief, Division of Gastroenterology and Hepatology at Sinai Health/ University Health Network, Toronto.
"We are proud to be able to offer a well-tolerated and efficacious treatment with a novel mechanism of action to Canadian adults suffering from IBS-C", said Jody Engel, Country Manager Canada at Knight Therapeutics Inc.
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. By inhibiting NHE3 on the apical surface of the enterocytes, IBSRELA 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.
IBSRELA 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, IBSRELA reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.
Tenapanor is also being evaluated for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. Tenapanor's unique mechanism of action blocks phosphorus absorption through the paracellular pathway, the primary pathway of phosphate absorption. Ardelyx submitted an NDA to the FDA in the United States in September 2020 with a PDUFA date of April 29, 2021. Knight has the exclusive right to commercialize tenapanor in Canada for this indication.
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 Canada and Latin America. Knight owns Biotoscana Investments S.A., 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 .
Forward-Looking Statements for Knight Therapeutics Inc.
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, 2019 as filed on www.sedar.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information or future events, except as required by law.
Dr. Louis Liu has received honoraria from Knight Therapeutics Inc. as a consulting physician relating to medical advisory board participation.
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