STOCKHOLM, Aug. 9, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX)
("Calliditas") today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation (FTD) for
its lead NOX inhibitor candidate setanaxib for the treatment of
patients with the chronic orphan liver disease primary biliary
cholangitis (PBC). Setanaxib has previously been granted orphan
drug designation for PBC in the US and Europe.
The FDA Fast Track program facilitates the expedited development
and review of new drugs intended to treat serious or
life-threatening conditions and that demonstrate the potential to
address unmet medical need. The FDA created this process to
expedite the delivery of important new drugs to patients, and
programs with FTD can potentially take advantage of early and
frequent communication with the FDA, as well as rolling submission
of the marketing application.
"We are delighted to receive Fast Track designation and look
forward to working closely with the FDA towards our aim of
establishing setanaxib as the potential first NOX inhibitor for PBC
patients," said CEO Renée Aguiar-Lucander.
In a Phase 2 clinical trial, setanaxib demonstrated evidence of
anti-fibrotic activity as measured by Fibroscan, combined with a
favorable tolerability profile, as well as a statistically
significant impact on fatigue. Following positive results from a
Phase 1 study conducted in 2020 which evaluated higher doses of
setanaxib in healthy volunteers, Calliditas is planning to initiate
a pivotal Phase 2/3 study in PBC, starting in 2H 2021.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on August 9, 2021, at 8:00
a.m. CET.
About Calliditas
Calliditas Therapeutics is a specialty pharmaceutical 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 candidate, Nefecon, is a proprietary, novel oral
formulation of budesonide, an established, highly potent local
immunosuppressant, for the treatment of the autoimmune renal
disease IgA nephropathy, or IgAN, for which there is a high unmet
medical need and there are no approved treatments. Calliditas read
out top line data from its ongoing global Phase 3 study within IgAN
and has filed for accelerated and conditional approval. If
approved, Calliditas aims to commercialize Nefecon itself in
the United States. Calliditas is
listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global
Select Market (ticker: CALT). Visit www.calliditas.com for further
information.
About setanaxib
Setanaxib (GKT831), a NOX1 and NOX4 inhibitor, has shown
evidence of anti-fibrotic activity in a Phase II clinical trial in
primary biliary cholangitis (PBC, an orphan liver disease). Based
on its Phase II results, a phase 2/3 trial with setanaxib in PBC is
being planned. In addition, a proof-of-concept study in head and
neck cancer is planned to start in the 2nd half of 2021.
Setanaxib is also being evaluated in an investigator-initiated
Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD)
as well as being studied in an investigator led Phase II clinical
trial in idiopathic pulmonary fibrosis (IPF), a chronic lung
disease that results in fibrosis of the lungs.
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, business plans, regulatory
submissions and focus. 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, the
potential for FDA acceptance for and the success and timeline of
the development of setanaxib, clinical trials, supply chain,
strategy, goals and anticipated timelines, competition from other
biopharmaceutical companies, 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.
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