STOCKHOLM, Nov. 30, 2023 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX)
('Calliditas') today announced the initiation of a Phase 2
clinical study to evaluate setanaxib in Alport syndrome.
Calliditas is a company focused on developing and
commercializing novel treatments in rare diseases with significant
unmet medical needs.
This randomized, double-blind, placebo-controlled study will
evaluate setanaxib in approximately 20 patients with a genetic
diagnosis of Alport syndrome and significant proteinuria despite
treatment with a renin-angiotensin system (RAS) blocker. The
duration of treatment is 24 weeks. The objective is to evaluate the
safety and tolerability of setanaxib in patients with Alport
syndrome, as well as the effect of setanaxib on UPCR and eGFR
compared to placebo.
"There is an urgent clinical need in Alport syndrome for
treatments that delay the progression to kidney failure," said Dr
Rachel Lennon, Professor of
Nephrology and Honorary Consultant Pediatric Nephrologist,
University of Manchester (UK), and Coordinating Investigator for
the study. "Alport syndrome can occur as early as the teenage
years, when it causes major disruption to learning and education.
Clinical trials allow new treatments such as setanaxib to be
evaluated for safety and effectiveness in Alport syndrome."
Setanaxib is also being evaluated in Phase 2 studies in squamous
cell carcinoma of the head and neck, primary biliary cholangitis,
and idiopathic pulmonary fibrosis.
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on November 30, 2023 at 8:30
a.m. CET.
About Calliditas
Calliditas Therapeutics is a commercial stage biopharma company
based in Stockholm, Sweden focused
on identifying, developing and commercializing novel
treatments in orphan indications, with an initial focus on renal
and hepatic diseases with significant unmet medical needs.
Calliditas' lead product, developed under the name
Nefecon®, has been granted accelerated approval by the
US FDA under the trade name TARPEYO®
and conditional marketing authorization by the European
Commission under the trade name Kinpeygo®.
Kinpeygo is being commercialized in the European Union Member
States by Calliditas' partner, STADA Arzneimittel
AG. Additionally, Calliditas is conducting a Phase
2b clinical trial in primary biliary
cholangitis, a Phase 2 proof-of- concept trial in head and
neck cancer, and a Phase 2a trial in Alport syndrome with its NOX
inhibitor product candidate, setanaxib. Calliditas' common shares
are listed on Nasdaq Stockholm (ticker: CALTX) and its American
Depositary Shares are listed on the Nasdaq Global Select Market
(ticker: CALT).
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding Calliditas' strategy, clinical development plans,
business plans, and regulatory submissions. The words "may,"
"will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," "estimate," "predict,"
"project," "potential," "continue," "target," and similar
expressions are intended to identify forward looking
statements, although not all forward-looking statements
contain these identifying words. Any forward looking
statements in this press release are based on management's
current expectations and beliefs and are subject to a
number of risks, uncertainties, and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, any related
to Calliditas' business, operations, clinical trials (including as
to the timing of the Company's clinical trial of setanaxib in
Alport syndrome), strategy, goals and anticipated timelines,
competition from other biopharmaceutical companies, revenue and
product sales projections or forecasts and other risks identified
in the section entitled "Risk Factors" in Calliditas' reports filed
with the Securities and Exchange Commission. Calliditas cautions
you not to place undue reliance on any forward-looking statements,
which speak only as of the date they are made. Calliditas disclaims
any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions, or
circumstances on which any such statements may be based, or that
may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements. Any
forward-looking statements contained in this press release
represent Calliditas' views only as of the date hereof and should
not be relied upon as representing its views as of any subsequent
date.
The following files are available for download:
https://mb.cision.com/Main/16574/3885432/2464050.pdf
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