Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the
Company and its collaborators will present nine abstracts,
including the interim analysis from the ongoing Phase 3 PROTECT
Study evaluating FILSPARI™ (sparsentan) versus an active comparator
in IgA nephropathy (IgAN), at the 60th ERA Congress in Milan,
Italy, June 15-18, 2023. Also included in the presentations is a
new analysis of the UK RaDaR Registry estimating the delay in time
to kidney failure or death based on proteinuria reduction in IgAN,
which has been designated among the 10 best-ranked abstracts of
2023 by ERA.
“We’re pleased to bring to the ERA Congress the strong interim
results from our ongoing PROTECT Study which demonstrate that
sparsentan significantly reduces proteinuria in IgA nephropathy,”
said Jula Inrig, M.D., chief medical officer of Travere
Therapeutics. “We also look forward to sharing more data from the
IgA nephropathy field showing the relationship between reducing
proteinuria in IgA nephropathy and preservation of kidney
function.”
Mini-Lecture Presentations
Estimating Delay in Time to Kidney Failure or Death for
Treatment Effects on Proteinuria in IgA
NephropathySession: The Art of Staring at Urine: Studies
in IgA NephropathyLocation & Time: Brown 1 & 2; Friday,
June 16, 2023, 12:34 – 12:47 p.m. CEST*Among the 10 best-ranked
abstracts of ERA Congress 2023
Superior Proteinuria Reduction with Sparsentan in
Immunoglobulin A Nephropathy (IgAN): PROTECT Study Interim
AnalysisSession: The Art of Staring at Urine: Studies in
IgA NephropathyLocation & Time: Brown 1 & 2, Friday, June
16, 2023, 1 - 1:15 p.m. CEST
Modeling Long-term Outcomes for Patients with
Immunoglobulin A Nephropathy (IgAN) from Short-term Proteinuria
DataSession: Navigating the IgA Nephropathy
PathwayLocation & Time: Amber 1 & 2, Saturday, June 17,
2023, 3:45 - 4:00 p.m. CEST
Alport Syndrome Natural History from the RaDaR Registry:
Associations with Gene, Variant Type and SexSession: Small
Patients, Big DataLocation & Time: Brown 1 & 2; Friday,
June 16, 2023, 5:34 - 5:47 p.m. CEST
Moderated Oral Presentation
Outcomes in SRNS (FSGS) Patients in the UK RaDaR
Idiopathic Nephrotic Syndrome Registry and Their Relationship with
Time-Averaged ProteinuriaSession: Moderated Orals
2.3Location & Time: Amber 6; Saturday, June 17, 2023, 2:57 -
3:02 p.m. CEST
Focused Oral Presentations
Matching-Adjusted Indirect Comparison of Sparsentan
Versus Delayed-Release Formulation Budesonide for Proteinuria
Reduction in Adult Patients with IgA NephropathySession:
Glomerular & Tubulo-interstitial DiseasesLocation & Time:
Room 9; Friday, June 16, 2023, 8:30 - 9:45 a.m. CEST
Humanistic Burden of Rare Kidney Diseases: Understanding
the Impact of IgAN and FSGS on Patients & Care-Partners Study
(HONUS): US IgAN Results UpdateSession: Glomerular &
Tubulo-interstitial DiseasesLocation & Time: Room 9; Friday,
June 16, 2023, 5 - 6:15 p.m. CEST
The Natural History of IgA Nephropathy in the German
Chronic Kidney Disease (GCKD) CohortSession: Glomerular
& Tubulo-interstitial DiseasesLocation & Time: Room 2;
Friday, June 16, 2023, 8:30 - 9:45 a.m. CEST
The Natural History of FSGS in the German Chronic Kidney
Disease (GCKD) CohortSession: Glomerular &
Tubulo-interstitial DiseasesLocation & Time: Room 9; Saturday,
June 17, 2023, 8:30 - 9:45 a.m. CEST
About IgA Nephropathy
IgA nephropathy (IgAN), also called Berger's
disease, is a rare progressive kidney disease characterized by the
buildup of immunoglobulin A (IgA), a protein that helps the body
fight infections, in the kidneys. The deposits of IgA cause a
breakdown of the normal filtering mechanisms in the kidney, leading
to blood in the urine (hematuria), protein in the urine
(proteinuria) and a progressive loss of kidney function. Other
symptoms of IgAN may include swelling (edema) and high blood
pressure.
IgAN is the most common type of primary
glomerulonephritis worldwide and a leading cause of kidney failure
due to glomerular disease. IgAN is estimated to affect up to
150,000 people in the U.S. and is one of the most common glomerular
diseases in Europe and Japan.
About Focal Segmental
Glomerulosclerosis
Focal segmental glomerulosclerosis (FSGS) is a
rare proteinuric kidney disorder in both children and adults that
is estimated to affect more than 40,000 patients in the US with
similar prevalence in Europe. The disorder is defined by
progressive scarring of the kidney and often leads to kidney
failure. FSGS is characterized by proteinuria, where protein leaks
into the urine due to a breakdown of the normal filtration
mechanism in the kidney. Once in the urine, protein is considered
to be toxic to other parts of the kidney, especially the tubules,
and is believed to contribute to further disease progression. Other
common symptoms include swelling in parts of the body, known as
edema, as well as low blood albumin levels, abnormal lipid profiles
and hypertension. There is currently no approved pharmacologic
indicated for the treatment of FSGS.
FILSPARI™ (sparsentan) U.S.
Indication
FILSPARI is an endothelin and angiotensin II
receptor antagonist indicated to reduce proteinuria in adults with
primary immunoglobulin A nephropathy (IgAN) at risk of rapid
disease progression, generally a UPCR ≥1.5 g/g.
This indication is granted under accelerated
approval based on reduction in proteinuria. It has not been
established whether FILSPARI slows kidney function decline in
patients with IgAN. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory clinical trial.
FILSPARI™ (sparsentan) Important
Safety Information
BOXED WARNING: HEPATOTOXICITY AND
EMBRYO-FETAL TOXICITYBecause of the risks of
hepatotoxicity and birth defects, FILSPARI is available only
through a restricted program called the FILSPARI REMS. Under the
FILSPARI REMS, prescribers, patients and pharmacies must enroll in
the program.
HepatotoxicitySome
Endothelin Receptor Antagonists (ERAs) have caused elevations of
aminotransferases, hepatotoxicity, and liver failure. In clinical
studies, elevations in aminotransferases (ALT or AST) of at least
3-times the Upper Limit of Normal (ULN) have been observed in up to
2.5% of FILSPARI-treated patients, including cases confirmed with
rechallenge.
Measure transaminases and bilirubin
before initiating treatment and monthly for the first 12 months,
and then every 3 months during treatment. Interrupt treatment and
closely monitor patients who develop aminotransferase elevations
more than 3x ULN.
FILSPARI should generally be avoided in
patients with elevated aminotransferases (>3x ULN) at baseline
because monitoring for hepatotoxicity may be more difficult and
these patients may be at increased risk for serious
hepatotoxicity.
Embryo-Fetal
ToxicityFILSPARI can cause major birth defects if
used by pregnant patients based on animal data. Therefore,
pregnancy testing is required before the initiation of treatment,
during treatment and one month after discontinuation of treatment
with FILSPARI. Patients who can become pregnant must use effective
contraception before the initiation of treatment, during treatment,
and for one month after discontinuation of treatment with
FILSPARI.
Contraindications: FILSPARI is
contraindicated in patients who are pregnant. Do not coadminister
FILSPARI with angiotensin receptor blockers (ARBs), ERAs, or
aliskiren.
Warnings and Precautions
Hepatotoxicity: Elevations in ALT or AST of at
least 3-fold ULN have been observed. To reduce the risk of
potential serious hepatotoxicity, measure serum aminotransferase
levels and total bilirubin prior to initiation of treatment,
monthly for the first 12 months, then every 3 months during
treatment.
Advise patients with symptoms suggesting
hepatotoxicity (nausea, vomiting, right upper quadrant pain,
fatigue, anorexia, jaundice, dark urine, fever, or itching) to
immediately stop treatment with FILSPARI and seek medical
attention. If aminotransferase levels are abnormal at any time
during treatment, interrupt FILSPARI and monitor as
recommended.
Consider re-initiation of FILSPARI only when
hepatic enzyme levels and bilirubin return to pretreatment values
and only in patients who have not experienced clinical symptoms of
hepatotoxicity.
Avoid initiation of FILSPARI in patients with
elevated aminotransferases (>3x ULN) prior to drug
initiation.
Embryo-Fetal Toxicity: FILSPARI
can cause fetal harm. Advise patients who can become pregnant of
the potential risk to a fetus. Obtain a pregnancy test and advise
patients who can become pregnant to use effective contraception
prior to, during, and one month after discontinuation of FILSPARI
treatment.
FILSPARI REMS: FILSPARI is
available only through a restricted program under a REMS called the
FILSPARI REMS.
Important requirements include:
- Prescribers must be certified with the FILSPARI REMS by
enrolling and completing training.
- All patients must enroll in the FILSPARI REMS prior to
initiating treatment and comply with monitoring requirements.
- Pharmacies that dispense FILSPARI must be certified with the
FILSPARI REMS and must dispense only to patients who are authorized
to receive FILSPARI.Further information is available at
www.filsparirems.com or 1-833-513-1325.
Hypotension: There was a
greater incidence of hypotension-associated adverse events, some
serious, including dizziness, in patients treated with FILSPARI
compared to irbesartan. In patients at risk for hypotension,
consider eliminating or adjusting other antihypertensive
medications and maintaining appropriate volume status. If
hypotension develops, consider a dose reduction or dose
interruption of FILSPARI.
Acute Kidney Injury: Monitor
kidney function periodically. Patients whose kidney function may
depend in part on the activity of the renin-angiotensin system
(e.g., patients with renal artery stenosis, chronic kidney disease,
severe congestive heart failure, or volume depletion) may be at
particular risk of developing acute kidney injury on FILSPARI.
Consider withholding or discontinuing therapy in patients who
develop a clinically significant decrease in kidney function while
on FILSPARI.
Hyperkalemia: Monitor serum
potassium periodically and treat appropriately. Patients with
advanced kidney disease, taking concomitant potassium-increasing
drugs (e.g., potassium supplements, potassium-sparing diuretics),
or using potassium-containing salt substitutes are at increased
risk for developing hyperkalemia. Dosage reduction or
discontinuation of FILSPARI may be required.
Fluid Retention: Fluid
retention may occur with ERAs, and has been observed with FILSPARI.
If clinically significant fluid retention develops, after
evaluation, consider modifying the dose of FILSPARI.
Most common adverse reactions (5%) with
FILSPARI are peripheral edema, hypotension (including
orthostatic hypotension), dizziness, hyperkalemia, and anemia.
Drug interactions
-
Renin-Angiotensin System (RAS) Inhibitors and
ERAs: Do not coadminister FILSPARI with angiotensin
receptor blockers (ARBs), ERAs, or aliskiren.
- Strong
and Moderate CYP3A Inhibitors: Avoid concomitant use of
FILSPARI with strong CYP3A inhibitors. Monitor blood pressure,
serum potassium, edema, and kidney function regularly when used
concomitantly with moderate CYP3A inhibitors.
- Strong
CYP3A Inducers: Avoid concomitant use with a strong CYP3A
inducer.
- Antacids
and Acid Reducing Agents: Administer FILSPARI 2 hours
before or after administration of antacids. Avoid concomitant use
of acid reducing agents (histamine H2 receptor antagonist and PPI
proton pump inhibitor) with FILSPARI.
-
Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including
Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for
signs of worsening renal function.
- CYP2B6,
2C9, and 2C19 Substrates: Monitor for efficacy of the
concurrently administered CYP2B6, 2C9, and 2C19 substrates and
consider dosage adjustment in accordance with the Prescribing
Information.
- P-gp and
BCRP Substrates: Avoid concomitant use of sensitive
substrates of P-gp and BCRP with FILSPARI.
- Agents
Increasing Serum Potassium: Monitor serum potassium
frequently. Concomitant use of FILSPARI with potassium-sparing
diuretics, potassium supplements, potassium-containing salt
substitutes, or other drugs that raise serum potassium levels may
result in hyperkalemia.
Use in specific populations
-
Pregnancy / Females and Males of Reproductive
Potential: FILSPARI can cause fetal harm, including birth
defects and fetal death, when administered to a pregnant patient
and is contraindicated during pregnancy.
-
Pregnancy Testing / Contraception: Verify the
pregnancy status and effective method of contraception prior to,
during, and one month after discontinuation of FILSPARI treatment.
The patient should contact their physician immediately for
pregnancy testing if onset of menses is delayed or pregnancy is
suspected.
-
Lactation: Advise patients not to breastfeed
during treatment with FILSPARI.
- Hepatic
Impairment: Avoid use of FILSPARI in patients with any
hepatic impairment (Child-Pugh class A-C).
Please see Full Prescribing Information
for FILSPARI here.
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 the efficacy, safety and tolerability profile of
sparsentan based on the preliminary data from the PROTECT interim
analysis; and the relationship between reducing proteinuria in IgA
nephropathy and preservation of kidney function. 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. The Company faces risks associated with market
acceptance of its commercial 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 anticipated future clinical trials
will not proceed as planned. Specifically, the Company faces the
risk that the results from the Phase 3 DUPLEX Study of sparsentan
in FSGS will not serve as a basis for a regulatory submission for
approval of sparsentan for FSGS and the 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 further
approval of sparsentan. 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, including as a
result of macroeconomic conditions; 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 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 also faces additional risks
associated with global and macroeconomic conditions, including
health epidemics and pandemics, including risks related to
potential disruptions to clinical trials, commercialization
activity, supply chain, and manufacturing operations. 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 under the heading “Risk
Factors” in the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, as filed with
the Securities and Exchange Commission (“SEC”)
on May 4, 2023, and other filings with the SEC.
Media:Nivi NehraVice President, Corporate
Communications888-969-7879 mediarelations@travere.com |
Investors:Naomi EichenbaumVice President, Investor
Relations888-969-7879 IR@travere.com |
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