SOUTH SAN FRANCISCO, Calif.,
Dec. 21, 2021 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced
that its collaboration partner, Kissei Pharmaceutical Co., Ltd.
("Kissei"), has released positive topline results from its Phase 3
clinical trial in Japan evaluating
fostamatinib disodium hexahydrate for the treatment of adult
chronic immune thrombocytopenia (ITP).
The Phase 3 clinical study (n=34) showed that patients receiving
fostamatinib (R788) achieved a stable platelet response
significantly higher than patients receiving a placebo
control. A stable platelet response was defined as achieving
greater than or equal to 50,000 platelets per μL of blood on at
least four of the last six scheduled visits between weeks 14 and 24
of treatment. The safety profile of fostamatinib was consistent
with other clinical trials, with no new or unusual safety issues
observed.
"We are encouraged by these initial Phase 3 results showing the
potential of fostamatinib for treating chronic ITP in Japan," said Mutsuo
Kanzawa, Chairman and CEO of Kissei. "There is an estimated
17,0001 people living with ITP in Japan. Kissei strives to provide new treatment
options by engaging in R&D in the field of rare diseases,
including chronic immune thrombocytopenia."
In October 2018, Rigel entered
into an exclusive license and supply agreement with Kissei to
develop and commercialize fostamatinib in all current and potential
indications in Japan, China, Taiwan
and the Republic of Korea. Fostamatinib is commercially available
in the United States under the
brand name TAVALISSE® for the treatment of adult
patients with chronic ITP who have had an insufficient response to
a previous treatment.
"These Phase 3 results add to the body of evidence demonstrating
fostamatinib may provide a meaningful benefit to people with ITP,"
said Wolfgang Dummer, M.D., Ph.D.,
executive vice president and chief medical officer of Rigel.
"Fostamatinib has a unique mechanism of action that addresses the
underlying autoimmune basis of ITP by impeding platelet
destruction. We also continue to evaluate the potential of
fostamatinib to treat warm antibody autoimmune hemolytic anemia
(wAIHA), another rare blood disorder in which the immune system
destroys blood cells."
Raul Rodriguez, president and
chief executive officer of Rigel, continued: "We have great
confidence in our collaboration partner, Kissei, and look forward
to potentially bringing treatment with fostamatinib to patients
with ITP in Japan and other Asian
countries where there is a need."
Fostamatinib has Orphan Drug Designation in Japan.
About ITP
In patients with ITP, the immune
system attacks and destroys the body's own blood platelets, which
play an active role in blood clotting and healing. Common
symptoms of ITP are excessive bruising and bleeding. People
suffering with chronic ITP may live with an increased risk of
severe bleeding events that can result in serious medical
complications or even death. Current therapies for ITP
include steroids, blood platelet production boosters (TPO receptor
agonists) and splenectomy. However, not all patients are adequately
treated with existing therapies. As a result, there remains a
significant medical need for additional treatment options for
patients with ITP.
ITP is designated as an "intractable disease" by the Minister of
Health, Labour and Welfare in Japan. The number of patients with ITP is
estimated to be approximately 17,0001 and 2.16 per
100,0002 people are newly diagnosed with ITP every year
in Japan.
About
TAVALISSE
Indication
TAVALISSE® (fostamatinib
disodium hexahydrate) tablets is indicated for the treatment of
thrombocytopenia in adult patients with chronic immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment.
Important Safety Information
Warnings and Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the
hypertensive effects. Monitor blood pressure every 2 weeks until
stable, then monthly, and adjust or initiate antihypertensive
therapy for blood pressure control maintenance during therapy. If
increased blood pressure persists, TAVALISSE interruption,
reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can
occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to >3 x upper limit of normal, manage
hepatotoxicity using TAVALISSE interruption, reduction, or
discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea
occurred in 1% of patients treated with TAVALISSE. Monitor patients
for the development of diarrhea and manage using supportive care
measures early after the onset of symptoms. If diarrhea becomes
severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE;
febrile neutropenia occurred in 1% of patients. Monitor the ANC
monthly and for infection during treatment. Manage toxicity with
TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant
women. Advise pregnant women about the potential risk to a fetus.
Advise females of reproductive potential to use effective
contraception during treatment and for at least 1 month after the
last dose. Verify pregnancy status prior to initiating TAVALISSE.
It is unknown if TAVALISSE or its metabolite is present in human
milk. Because of the potential for serious adverse reactions in a
breastfed child, advise a lactating woman not to breastfeed during
TAVALISSE treatment and for at least 1 month after the last
dose.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full
Prescribing Information.
To report side effects of prescription drugs to the FDA,
visit www.fda.gov/medwatch or call 1-800-FDA-1088
(800-332-1088).
TAVALISSE and TAVLESSE are registered trademarks of Rigel
Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated
to developing, and commercializing novel small molecule drugs that
significantly improve the lives of patients with hematologic
disorders, cancer, and rare immune diseases. Rigel's pioneering
research focuses on signaling pathways that are critical to disease
mechanisms. The company's first FDA-approved product is
TAVALISSE® (fostamatinib disodium hexahydrate)
tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for
the treatment of adult patients with chronic immune
thrombocytopenia who have had an insufficient response to a
previous treatment. The product is also commercially available in
Europe (TAVLESSE), the
United Kingdom, and Canada (TAVALISSE) for the treatment of
chronic immune thrombocytopenia in adult patients.
Fostamatinib is currently being studied in a Phase 3 clinical
trial (NCT03764618) for the treatment of warm autoimmune hemolytic
anemia (wAIHA)3; a Phase 3 clinical trial (NCT04629703)
for the treatment of hospitalized high-risk patients with
mild-to-moderate COVID-193; an NIH/NHLBI-funded Phase 3
ACTIV-4 Host Tissue Study (NCT04924660) for the treatment of
COVID-19 in hospitalized patients on oxygen therapy, and a Phase 2
clinical trial (NCT04581954) for the treatment of COVID-19 being
conducted by Imperial College London.
Rigel's other clinical programs include its interleukin
receptor-associated kinase (IRAK) inhibitor program, and a
receptor-interacting serine/threonine-protein kinase (RIP1)
inhibitor program in clinical development with partner Eli Lilly
and Company. In addition, Rigel has product candidates in
development with partners AstraZeneca, BerGenBio ASA, and Daiichi
Sankyo.
For further information, visit www.rigel.com or follow us on
Twitter or LinkedIn.
- Estimated by Kissei based on the number of patients in
Japan having certificates issued
for specific disease treatment (designated intractable
disease)
- Int J Hematol, 2011, 93: 329-35
- The product for this use or indication is investigational and
has not been proven safe or effective by any regulatory
authority.
Forward Looking Statements
This press release contains forward-looking statements relating
to, among other things, that fostamatinib may provide a meaningful
benefit to people with ITP. Forward-looking statements can be
identified by words such as "plan", "potential", "may", "expects",
"will" and similar expressions in reference to future periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on
Rigel's current beliefs, expectations, and assumptions regarding
the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions, and hence they inherently involve significant
risks, uncertainties and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Therefore, you should not rely on any of these
forward-looking statements. Actual results and the timing of
events could differ materially from those anticipated in such
forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks that the
PMDA or other regulatory authorities may make adverse decisions
regarding fostamatinib; risks that fostamatinib clinical trials may
not be predictive of real-world results or of results in subsequent
clinical trials; risks that fostamatinib may have unintended side
effects, adverse reactions or incidents of misuses; as well as
other risks detailed from time to time in Rigel's reports filed
with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended September 30, 2021. Any forward-looking statement
made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. Rigel does not undertake any
obligation to update forward-looking statements, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise, and expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein.
Contacts:
For Investors
Jodi Sievers – Rigel
Pharmaceuticals
Phone: 650.624.1232
Email: ir@rigel.com
For Media
Emily Correia
– Syneos Health
Phone: 508.314.3157
Email: emily.correia@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.