Travere Therapeutics Announces Presentation of Abstracts at ERA-EDTA Congress 2021
June 04 2021 - 8:00AM
Travere Therapeutics (NASDAQ: TVTX) today announced presentations
including nonclinical data examining the renal protective effects
of sparsentan, a high affinity antagonist of both endothelin type A
(ETA) and angiotensin II type 1 (AT1) receptors, in focal segmental
glomerulosclerosis (FSGS) mouse models, at the 58th European Renal
Association – European Dialysis and Transplant Association
(ERA-EDTA) Congress. The Company and its collaborators will also
present analyses from independent randomized controlled studies and
registries exploring the beneficial treatment effects of reducing
proteinuria in FSGS and IgA nephropathy. ERA-EDTA is being held
virtually June 5-8, 2021.
Oral Presentations:
Sparsentan improves glomerular blood
flow and augments protective tissue remodeling in mouse models of
focal segmental glomerulosclerosisPresentation #:
MO1132Session Title: Pathology meets clinicsDate &
Time: Monday, June 7, 2021, 17:00-18:30 CEST
Estimating delay in time to ESKD for treatment effects
on proteinuria in IgA nephropathy and FSGSPresentation #:
MO246Session: Moderated Mini-Orals 2Date &
Time: Sunday, June 6, 2021, 16:30-17:45 CEST
The treatment effect of RAS blockade on proteinuria in
IgA nephropathy patients as a surrogate for renal events and
decline in eGFR: An analysis of randomized controlled
trialsPresentation #:
MO256Session: GlomerulonephritisDate &
Time: Available beginning June 5, 2021
About Sparsentan
Sparsentan is a novel investigational product
candidate, that functions as a high affinity dual-acting antagonist
of both the endothelin type A and angiotensin II type 1 receptors,
in a single molecule. Pre-clinical data have shown that blockade of
both pathways in forms of rare chronic kidney disease, reduces
proteinuria, protects podocytes and prevents glomerulosclerosis and
mesangial cell proliferation. Sparsentan has been granted Orphan
Drug Designation for the treatment of IgAN and FSGS in the U.S. and
Europe.
Sparsentan is currently being evaluated in the
pivotal Phase 3 DUPLEX Study for the treatment of focal segmental
glomerulosclerosis (FSGS) and the pivotal Phase 3 PROTECT Study for
the treatment of IgAN. In February 2021, the Company announced that
the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in FSGS
achieved its pre-specified interim FSGS partial remission of
proteinuria endpoint (FPRE) with statistical significance. FPRE is
a clinically meaningful endpoint defined as urine
protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent
reduction in UP/C from baseline. After 36 weeks of treatment, 42.0
percent of patients receiving sparsentan achieved FPRE, compared to
26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary
results from the interim analysis suggest that at the time of the
interim assessment, sparsentan had been generally well-tolerated
and shown a comparable safety profile to irbesartan. In the Phase 2
DUET Study of sparsentan in FSGS, the combined treatment group met
its primary efficacy endpoint, demonstrating a greater than
two-fold reduction in proteinuria compared to irbesartan, and was
generally well tolerated after the eight-week, double-blind
treatment period. Irbesartan is part of a class of drugs used to
manage FSGS and IgAN in the absence of an approved pharmacologic
treatment. If approved for both indications, sparsentan could
potentially be the first medicine approved for both FSGS and
IgAN.
About Travere Therapeutics
At Travere Therapeutics we are in rare for life.
We are a biopharmaceutical company that comes together every day to
help patients, families and caregivers of all backgrounds as they
navigate life with a rare disease. On this path, we know the need
for treatment options is urgent – that is why our global team works
with the rare disease community to identify, develop and deliver
life-changing therapies. In pursuit of this mission, we
continuously seek to understand the diverse perspectives of rare
patients and to courageously forge new paths to make a difference
in their lives and provide hope – today and tomorrow. For more
information, visit travere.com
Forward Looking Statements
This press release contains "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing,
these statements are often identified by the words "may", "might",
"believes", "thinks", "anticipates", "plans", "expects", "intends"
or similar expressions. In addition, expressions of our strategies,
intentions or plans are also forward-looking statements. Such
forward-looking statements include, but are not limited to,
references to exploring the beneficial treatment effects of
reducing proteinuria in FSGS and IgA nephropathy; the potential
future regulatory approval of sparsentan for FSGS and IgAN; and, if
approved for both indications, the potential for sparsentan be the
first medicine approved for both FSGS and IgAN. Such
forward-looking statements are based on current expectations and
involve inherent risks and uncertainties, including factors that
could delay, divert or change any of them, and could cause actual
outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among
the factors that could cause actual results to differ materially
from those indicated in the forward-looking statements are risks
and uncertainties associated with the regulatory review and
approval process, including the Subpart H accelerated approval
pathway in the United States and the conditional marketing
authorization (CMA) pathway in Europe. Specifically, the Company
faces the risk that the Phase 3 DUPLEX Study of sparsentan in FSGS
will not demonstrate that sparsentan is safe or effective or serve
as a basis for accelerated approval of sparsentan as planned; risk
that the Phase 3 PROTECT Study of sparsentan in IgAN will not
demonstrate that sparsentan is safe or effective or serve as the
basis for accelerated approval of sparsentan as planned; and risk
that sparsentan will not be approved for efficacy, safety,
regulatory or other reasons, and for each of the Company’s
programs, risk associated with enrollment of clinical trials for
rare diseases and risk that ongoing or planned clinical trials may
not succeed or may be delayed for safety, regulatory or other
reasons. The Company faces risk that it will be unable to raise
additional funding that may be required to complete development of
any or all of its product candidates; risk relating to the
Company's dependence on contractors for clinical drug supply and
commercial manufacturing; uncertainties relating to patent
protection and exclusivity periods and intellectual property rights
of third parties; risks associated with regulatory interactions;
and risks and uncertainties relating to competitive products,
including current and potential future generic competition with
certain of the Company’s products, and technological changes that
may limit demand for the Company's products. The Company faces
additional risks associated with the potential impacts the COVID-19
pandemic may have on its business, including, but not limited to
(i) the Company’s ability to continue its ongoing development
activities and clinical trials, (ii) the timing of such clinical
trials and the release of data from those trials, (iii) the
Company’s and its suppliers’ ability to successfully manufacture
its commercial products and product candidates, and (iv) the market
for and sales of its commercial products. You are cautioned not to
place undue reliance on these forward-looking statements as there
are important factors that could cause actual results to differ
materially from those in forward-looking statements, many of which
are beyond our control. The Company undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise. Investors are
referred to the full discussion of risks and uncertainties as
included in the Company's most recent Form 10-Q, Form 10-K and
other filings with the Securities and Exchange Commission.
Contact:Chris Cline,
CFA
Senior Vice
President, Investor Relations & Corporate
Communications888-969-7879 IR@travere.com
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