Knight Therapeutics Announces Canadian Commercial Launch of IBSRELA™ - New Innovative Treatment for Irritable Bowel Syndrom...
March 01 2021 - 7:04PM
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.
About IBSRELA
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.
About Tenapanor
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.
Disclosure information:Dr. Louis Liu has
received honoraria from Knight Therapeutics Inc. as a consulting
physician relating to medical advisory board participation.
CONTACT INFORMATION:
Investor Contact: |
|
Knight Therapeutics Inc. |
|
Samira Sakhia |
Arvind Utchanah |
President & Chief Operating
Officer |
Chief Financial Officer |
T: 514.484.4483 ext.122 |
T. 514.484.4483 ext. 115 |
F: 514.481.4116 |
F. 514.481.4116 |
Email: info@knighttx.com |
Email: info@knighttx.com |
Website: www.gud-knight.com |
Website: www.gud-knight.com |
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