Retrophin Announces Presentation of Abstracts at ASN Kidney Week 2020 Reimagined
09 Octubre 2020 - 3:01PM
Retrophin, Inc. (NASDAQ: RTRX) today announced that it will present
new data from a post-hoc analysis examining the proportion of
patients with focal segmental glomerulosclerosis (FSGS) that
achieved complete remission of proteinuria in the Phase 2 DUET
Study, at the American Society of Nephrology (ASN) Kidney Week 2020
Reimagined. The Company and its collaborators will also feature
encore presentations of preclinical data supporting the potential
for sparsentan to protect kidney function in additional rare
glomerular diseases. ASN Kidney Week 2020 Reimagined is being held
virtually October 19–25, 2020.
Oral
Presentation:
Complete Remission of Proteinuria in
Patients with FSGS Treated with Sparsentan, a Dual Endothelin and
Angiotensin Receptor Antagonist, in the DUET TrialSession
#: OR1203Session Title: Halfway Through the Marathon: Clinical
Candidates in DevelopmentDate & Time: Sunday, October 25, 2020,
5:00 p.m. – 7:00 p.m. ET
Poster
Presentations:
Sparsentan Protects Against Development
of Albuminuria and Glomerulosclerosis in the
gddY Mouse Model of IgA
NephropathyePoster #: PO1808Session: Glomerular Diseases:
IgA, C3G, and FSGSSession Release Date & Time: Thursday,
October 22, 2020, 10:00 a.m. ET
The Dual Endothelin/Angiotensin II
Receptor Antagonist Sparsentan Slows Renal
Disease, Improves Lifespan, and Attenuates Hearing Loss in Alport
Mice: Comparison with Losartan and
AtrasentanePoster #: PO1897Session: Glomerular
Diseases: Clinical, Outcomes, and TrialsSession Release Date &
Time: Thursday, October 22, 2020, 10:00 a.m. ET
About Sparsentan
Sparsentan is an investigational product
candidate in Phase 3 clinical development that has a dual mechanism
of action combining endothelin receptor type A blockade with
angiotensin receptor blockade. Retrophin is developing sparsentan
for the treatment of FSGS and IgAN, rare kidney disorders that
often lead to end-stage kidney disease (ESKD). In several forms of
chronic kidney disease, such as FSGS and IgAN, endothelin receptor
blockade has been shown to have an additive beneficial effect on
proteinuria in combination with renin-angiotensin blockade via
angiotensin receptor blockers or angiotensin converting enzyme
inhibitors. Sparsentan has been granted orphan drug designation for
the treatment of FSGS by the FDA and European Commission.
The Phase 2 DUET Study of sparsentan in FSGS met
its primary efficacy endpoint for the combined treatment group,
demonstrating a greater than two-fold reduction in proteinuria
compared to irbesartan, 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. Retrophin is currently enrolling the pivotal Phase 3
DUPLEX Study of sparsentan for the treatment of FSGS
(FSGSduplex.com), as well as the pivotal Phase 3 PROTECT Study of
sparsentan for the treatment of IgAN (IgANprotect.com). Both
studies contain 36-week proteinuria-based endpoints, which if
achieved, are expected to support submission of a New Drug
Application (NDA) under the Subpart H accelerated approval pathway
in the U.S. as well as an application for Conditional Marketing
Authorization (CMA) consideration in Europe. If approved for both
indications, sparsentan could potentially be the first medicine
approved for FSGS and IgAN.
About Retrophin
Retrophin is a biopharmaceutical company
specializing in identifying, developing and delivering
life-changing therapies to people living with rare disease. The
Company’s approach centers on its pipeline featuring sparsentan, a
product candidate in late-stage development for focal segmental
glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare
disorders characterized by progressive scarring of the kidney often
leading to end-stage kidney disease. Research in additional rare
diseases is also underway, including partnerships with leaders in
patient advocacy and government research to identify potential
therapeutics for NGLY1 deficiency and Alagille syndrome, conditions
with no approved treatment options. Retrophin’s R&D efforts are
supported by revenues from the Company’s commercial products
Chenodal®, Cholbam®, Thiola® and Thiola EC®.
Retrophin.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 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 Company’s business and
finances in general, success of its commercial products as well as
risks and uncertainties associated with the Company's preclinical
and clinical stage pipeline. Specifically, the Company faces risks
associated with market acceptance of its marketed products
including efficacy, safety, price, reimbursement and benefit over
competing therapies. The risks and uncertainties the Company faces
with respect to its preclinical and clinical stage pipeline include
risk that the Company's clinical candidates will not be found to be
safe or effective and that current or future clinical trials will
not proceed as planned. Specifically, the Company faces the risk
that the Phase 3 clinical trial 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 clinical trial 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 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. Also, there is
no guarantee that the preclinical findings that are summarized in
the abstracts that are a subject of this press release will
translate to a viable therapeutic approach in patients or that the
findings related to sparsentan from the post-hoc analysis of the
DUET Study data will be seen in the currently ongoing Phase 3
DUPLEX study. 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;
risks and uncertainties relating to competitive products, including
potential generic competition with certain of the Company’s
products, and technological changes that may limit demand for the
Company's 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-K, Form 10-Q and other filings with the
Securities and Exchange Commission.
Contact:Chris Cline, CFASenior Vice President,
Investor Relations & Corporate
Communications888-969-7879IR@retrophin.com
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