SOUTH SAN FRANCISCO, Calif.,
July 14, 2021 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that data
from its clinical development program for TAVALISSE®
(fostamatinib disodium hexahydrate) tablets will be highlighted in
two presentations at the upcoming International Society on
Thrombosis and Haemostasis (ISTH) Virtual Congress, taking place
online from July 17 – 21, 2021.
"For patients who remain on TAVALISSE for a year or more, we
found that their initial response was not the final response and
platelet counts continued to increase over time," said Wolfgang Dummer, MD, PhD, chief medical officer
for Rigel. "This is due to TAVALISSE's mechanism of action, SYK
inhibition, which blocks the autoimmune response that leads to
platelet destruction, allowing the patient's platelet count to
build in a natural and gradual way."
"The post-hoc analyses that will be presented at ISTH show that
treatment with TAVALISSE results in continuously increasing
platelet counts over the first year of treatment, highlighting the
potential benefit for ITP patients of longer-term treatment," said
Raul Rodriguez, Rigel's president
and CEO. "By evaluating these patient groups, we are able to
provide clinicians with further insight into how duration of
therapy and treatment in earlier lines of therapy can potentially
impact clinical outcomes."
Fostamatinib is an oral drug designed to inhibit spleen tyrosine
kinase (SYK), a key signaling component of the autoimmune process
that leads to platelet destruction in immune thrombocytopenia
(ITP). Fostamatinib is commercially available in the U.S. under the
brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets
and is the first and only SYK inhibitor indicated for the treatment
of thrombocytopenia in adult patients with chronic ITP who have had
an insufficient response to a previous treatment.
All ePosters will be made available online during the Poster
Networking Session on the conference website on Saturday, July 17, 2021, at 4:00 p.m. Eastern Time.
Abstract Presentation Number: PB0815
Title: Time Course of Response to Fostamatinib, an Oral
Spleen Tyrosine Kinase (SYK) Inhibitor for the Treatment of Immune
Thrombocytopenia (ITP)
Presenting
Author: Michelle Sholzberg, MDCM, Division Head of
Hematology-Oncology and the Medical Director of the Coagulation
Laboratory at St. Michael's
Hospital, Toronto
In a post-hoc analysis of the Rigel FIT Phase 3 program, for the
58 patients treated for ≥1 year, clinical endpoints were assessed
in 3-month increments over the first year:
- Patients treated for ≥1 year, had a response rate (achieved a
platelet count ≥50,000/µL) of 91% (53/58), 71% (41/58) within 12
weeks, with median platelet counts continuing to increase in each
3-month period of the first year of treatment.
- Incidence of bleeding events and use of rescue therapy
continually decreased in these 58 patients over the first year of
treatment with fostamatinib.
Abstract Presentation Number: PB0833
Title: Treatment of Immune Thrombocytopenia (ITP) in
the COVID-19 Era: Fostamatinib, an Oral Spleen Tyrosine Kinase
(SYK) Inhibitor
Presenting Authors: Nichola
Cooper, Asad Charania, Alice Hart, Christine Ademokun, and Robert Numerof
A review of safety and efficacy data from the fostamatinib Phase
3 program evaluated dosing and titration, incidence of infections,
thrombocytosis and thrombosis, and the immune response to pathogens
to assess the potential benefits of TAVALISSE for the unique
challenges of treating ITP during the pandemic. Findings
include:
- A reduced need for office visits due to oral administration,
easy titration, and low incidence of thrombocytosis.
- Fostamatinib's unique mechanism of action provide increased
hemostasis and may reduce the risk of thrombosis.
- Fostamatinib is not an immunosuppressant drug.
In addition to the poster presentations, Rigel is participating
in a virtual symposium:
Title: Role of Spleen Tyrosine Kinase (SYK) and SYK
Inhibition in Disease Pathways
Date and Time: Sunday, July 18, 2021, 12:30 - 1:30 p.m. ET
Presenters:
- Dr. Vadim Markovtsov – SYK in Human Biology and Disease
Pathways
- Dr. Nichola Cooper – Clinical
Trials with SYK Inhibitors
- Dr. Craig Kessler,
Moderator
About ITP
In patients with ITP (immune
thrombocytopenia), 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 include fatigue,
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. In addition
to fostamatinib, current therapies for ITP include steroids, blood
platelet production boosters (TPO-RAs), and splenectomy. However,
not all patients respond to existing therapies. As a result, there
remains a significant medical need for additional treatment options
for patients with ITP.
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 discovering, developing, and
providing 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) 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)1; a Phase 3 clinical trial (NCT04629703)
for the treatment of hospitalized high-risk patients with
mild-to-moderate COVID-191; an NIH/NHLBI-sponsored Phase
3 clinical trial for the treatment of COVID-19 in hospitalized
patients on oxygen therapy, and a Phase 2 clinical trial for the
treatment of COVID-19 being conducted by Imperial College London.
An NIH/NHLBI-sponsored Phase 2 clinical trial for the treatment of
hospitalized patients with COVID-19, in collaboration with Inova
Health System, was recently completed.
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.
1The product for this use or indication is
investigational and has not been proven safe or effective by any
regulatory authority.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
potential benefit for ITP patients of longer-term treatment with
TAVALISSE. Any statements contained in this press release that are
not statements of historical fact may be deemed to be
forward-looking statements. Words such as "potential", "may",
"expects", and similar expressions are intended to identify these
forward-looking statements. These forward-looking statements are
based on Rigel's current expectations and inherently involve
significant risks and uncertainties. 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 and
uncertainties associated with the commercialization and marketing
of TAVALISSE; risks that the FDA, EMA or other regulatory
authorities may make adverse decisions regarding fostamatinib;
risks that TAVALISSE clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that TAVALISSE may have unintended side effects, adverse
reactions or incidents of misuses; the availability of resources to
develop Rigel's product candidates; market competition; 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 March 31, 2021. In addition, the COVID-19
pandemic may result in further delays in Rigel's studies, trials
and sales, or impact Rigel's ability to obtain supply of TAVALISSE.
Rigel does not undertake any obligation to update forward-looking
statements and expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein.
Contact for Investors & Media:
Jodi Sievers - Rigel
Pharmaceuticals
Phone: 650.624.1232
Email: ir@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.