Knight Therapeutics Announces Approval of IBSRELA™ in Canada
17 April 2020 - 1:30PM
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.”
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 the United States mid-2020 with
expected approval in mid-2021.
About KnightKnight 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.
Forward-Looking StatementThis 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. For further information, please contact:
Knight Therapeutics Inc.Samira Sakhia President
T: 514-678-8930 F: 514-481-4116 info@gudknight.com
www.gudknight.com
Knight Therapeutics Inc.Arvind UtchanahChief
Financial OfficerT. 514.484.4483 ext. 115 F.
514.481.4116info@gudknight.com www.gudknight.com
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