FREMONT, Calif., March 19, 2018 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX) today announced a license agreement with Knight
Therapeutics, Inc. (TSX: GUD) (Knight) that provides Knight with
exclusive rights to commercialize tenapanor in Canada. Tenapanor is Ardelyx's oral,
first-in-class small molecule treatment that has completed Phase 3
development for irritable bowel syndrome with constipation (IBS-C)
and is being evaluated in a second Phase 3 study for
hyperphosphatemia.
Under the terms of the agreement, Ardelyx is eligible to receive
up to CAD 25 million in total
payments including an upfront payment and development and sales
milestones, as well as double-digit tiered royalties on net sales.
Knight will have the exclusive rights to market and sell tenapanor
in Canada.
"We are excited to bring Canadian patients a product like
tenapanor with its differentiated mechanism and established
efficacy and safety profiles in both IBS-C and hyperphosphatemia,"
said Jonathan Ross Goodman, chief
executive officer of Knight. "The addition of tenapanor to our
pipeline will further enhance Knight's leadership in GI disorders.
Because of its novel mechanism, we believe tenapanor will have
advantages in treating IBS-C through an entirely new approach than
those of today's approved medicines. In addition, we see great
potential for tenapanor as the first and only new option outside of
phosphate binders to treat hyperphosphatemia, with an opportunity
to make an important difference for patients who would benefit from
a new safe, effective and easy to take alternative. We look forward
to working with the Ardelyx team and Health Canada to bring
tenapanor to Canadian patients."
"Knight has a proven approach of successfully collaborating with
biotechnology companies to bring forward important medicines, which
makes them an invaluable component to our strategy of working with
industry leaders to bring tenapanor to patients with IBS-C and
hyperphosphatemia," said Mike Raab,
president and chief executive officer of Ardelyx. "This agreement
marks the third collaboration we have now put in place to support
the development and marketing of tenapanor in key geographies
outside of the U.S. With a highly differentiated product profile,
we believe that tenapanor will make a meaningful impact on Canadian
patients and are pleased to be collaborating with the experienced
and proven Knight team to make this a reality."
About Tenapanor
Tenapanor, discovered and developed by Ardelyx, is a
first-in-class, proprietary, minimally absorbed, oral, experimental
medication in late-stage clinical development. It has a unique
mechanism of action that, in IBS-C, acts by inhibiting, or
blocking, the NHE3 transporter in the gastrointestinal (GI) tract
to reduce the absorption of dietary sodium, which leads to an
increased amount of sodium within the gut. This increased sodium
increases water in the gut, which loosens stool, helping to
alleviate constipation. Preclinical studies have shown that
tenapanor may work to reduce abdominal pain caused by IBS-C through
the inhibition of TRPV-1 dependent signaling. Ardelyx has
successfully completed its T3MPO program designed to support the
registration of tenapanor for the treatment of IBS-C. Collectively,
the T3MPO-1 and T3MPO-2 Phase 3 trials demonstrated that tenapanor
had a durable effect on reducing constipation and abdominal pain
caused by IBS-C, in many patients treated. The favorable safety
profile of tenapanor is supported by the completed T3MPO-3
long-term, safety extension study. With the completion of this
program, Ardelyx is preparing a New Drug Application for tenapanor
for IBS-C, which the company intends to submit to the U.S. Food and
Drug Administration in the second half of 2018.
Tenapanor is also in Phase 3 development for the treatment of
hyperphosphatemia in patients with end-stage renal disease who are
on dialysis. In hyperphosphatemia, tenapanor blocks the NHE3 sodium
transporter in the GI tract, reducing the absorption of dietary
sodium and resulting in increased protons within the cells. The
increase in protons causes a reduction in phosphate uptake by
tightening junctions or pores that regulate phosphate absorption in
the GI tract. Overall, this mechanism appears to be preferential to
phosphate absorption given that Ardelyx has not observed any
meaningful changes in other ions, other than sodium, in preclinical
or clinical studies. Ardelyx completed its first Phase 3 clinical
trial for tenapanor in hyperphosphatemia, which demonstrated a
statistically significant primary endpoint, the difference in
change in serum phosphorus between the pooled tenapanor-treated
patients and placebo-treated patients from the end of the
eight-week treatment period to the end of the four-week randomized
withdrawal period, in the responder population. Tenapanor was
well-tolerated in the trial. Ardelyx has begun treating patients in
a second Phase 3 clinical trial, the Phreedom Trial, with data
anticipated in 2019.
About Ardelyx, Inc.
Ardelyx is focused on enhancing the way people with renal
diseases are treated by developing first-in-class medicines.
Ardelyx's renal pipeline includes the Phase 3 development of
tenapanor for the treatment of hyperphosphatemia in people with
end-stage renal disease who are on dialysis and RDX013, a potassium
secretagogue program for the potential treatment of high potassium,
or hyperkalemia, a problem among certain patients with kidney
and/or heart disease. In addition, Ardelyx has completed Phase 3
development of tenapanor for the treatment of irritable bowel
syndrome with constipation and anticipates submitting a New Drug
Application to the U.S. Food and Drug Administration for this
indication in the second half of 2018. To efficiently bring its
treatments to market, Ardelyx is pursing strategic collaborations
in the U.S. and beyond, with established agreements with Kyowa
Hakko Kirin in Japan, Fosun Pharma
in China and Knight Therapeutics
in Canada. For more information,
please visit http://www.ardelyx.com/ and connect with us on Twitter
@Ardelyx.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing
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.gudknight.com or www.sedar.com.
Ardelyx Forward Looking Statements
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Ardelyx, they
are forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor of the
Private Securities Reform Act of 1995, including the potential for
Ardelyx's product candidates in treating the diseases and
conditions for which they are being developed; the potential for
Ardelyx to receive upfront, milestone and royalty payments from
Knight Therapeutics, Inc.; Ardelyx's expected timing for the
filings of its NDA for tenapanor for the treatment of IBS-C,
Ardelyx's expected timing of its receipt of data from its second
Phase 3 clinical trial evaluating tenapanor for the treatment of
hyperphosphatemia; and Ardelyx's ability to establish
collaborations in the future. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
development of Ardelyx's product candidates or Ardelyx's future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in research and the clinical development process,
including the regulatory approval process. Ardelyx undertakes no
obligation to update or revise any forward-looking statements. For
a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to Ardelyx's
business in general, please refer to Ardelyx's Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
March 14, 2018, and its future
current and periodic reports to be filed with the Securities and
Exchange Commission.
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SOURCE Ardelyx, Inc.