STOCKHOLM, March 4, 2021 /PRNewswire/ -- Calliditas
Therapeutics AB (publ) ("Calliditas") today announced that it will
host a Key Opinion Leader (KOL) Perspectives webinar on the
Pathophysiology and Treatment of IgA Nephropathy in Clinical
Practice on Wednesday, March 10, 2021
at 10:00am Eastern Time.
The webinar will feature a presentation from KOL Richard
Lafayette, M.D., F.A.C.P., Stanford Healthcare, who will discuss
the pathophysiology of IgA nephropathy, the connection between the
gut and kidney, and how Calliditas' lead clinical candidate,
Nefecon, might be used in clinical practice, should it be approved.
Dr. Lafayette will be available to
answer questions following the formal presentation.
Calliditas management will also give a corporate update and
present data from the global Phase 3 NefIgArd trial. The pivotal
NefIgArd trial consists of two parts. Part A, which was designed to
support regulatory submissions, provided data on the efficacy and
safety of Nefecon. Calliditas read out positive topline data from
Part A of the trial on 8 November
2020, announcing that the study met its primary endpoint,
reduction in proteinuria, and key secondary endpoint stabilization
of eGFR. It also showed that Nefecon was generally
well-tolerated. Part B is designed to be a confirmatory post-market
approval observational trial to confirm long-term renal protection,
and was fully recruited in January
2021.
To register for the webinar, please click here.
Dr. Lafayette is Professor of
Medicine (Nephrology) and Director of the Stanford Glomerular
Disease Center at Stanford University
Medical Center in Stanford, CA.
His 25-year career in nephrology spans general nephrology,
transplant nephrology, and focuses on glomerular disease. During
this time, he has served as Senior Associate Chair of Medicine for
six years and Clinical Chief of Nephrology for more than a decade.
Dr. Lafayette was a member of the
first Kidney News Editorial Board and is a member of the ASN
Glomerular Diseases Advisory Group.
For further information, please contact:
Marie Galay, IR Manager,
Calliditas
Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on March 4, 2021 at 2:30 p.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 is
running a global Phase 3 study within IgAN and, if approved, aims
to commercialize Nefecon in the United
States. Calliditas is also planning to conduct clinical
trials with NOX inhibitors in PBC and oncology. Calliditas is
listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global
Select Market (ticker: CALT). Visit www.calliditas.com for further
information.
About Nefecon
Nefecon is a patented oral formulation of a potent and
well-known active substance - budesonide - for targeted release.
The formulation is designed to deliver the drug to the Peyer's
patch region of the lower small intestine, where the disease
originates, as per the predominant pathogenesis models. Nefecon is
derived from the TARGIT technology, which allows for the substance
to pass through the stomach and intestine without being absorbed,
and to be released in a pulse like fashion only when it reaches the
lower small intestine.
The combination of dose and optimized release profile is
required to be effective in patients with IgA nephropathy, as shown
in a large Phase 2b trial, completed
by the company. In addition to its potent local effect, another
advantage of using this active substance is that it has very low
bioavailability, i.e. around 90% of it is inactivated in the liver
before it reaches the systemic circulation. This means that a high
concentration can be applied locally where needed but with only
very limited systemic exposure and side effects.
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