SOUTH SAN FRANCISCO, Calif.,
June 3, 2020 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
announced that data related to R835, the company's investigational
IRAK1/4 inhibitor, will be presented in two oral and two poster
presentations at the European League Against Rheumatism (EULAR)
2020 E-Congress taking place June 3-6,
2020. A fifth abstract highlighting R835 has been accepted
for publication. The presentations will be made available on the
event's website at https://congress.eular.org/ on Wednesday, June 3 at 1:00
AM CEST.
The presentations will highlight the biological and
pharmacological characterization of R835, a potent and selective
inhibitor of both interleukin receptor associated kinase (IRAK)1
and IRAK4, and the results of the completed Phase 1 studies. In
multiple pre-clinical rodent models of acute and chronic
inflammation, R835 administration resulted in reduced inflammation,
and in Phase 1 human studies it showed encouraging
pharmacokinetic properties. In an intravenously administered
lipopolysaccharide (LPS) challenge study, proof-of-mechanism
for R835 was established by demonstrating the suppression of
inflammatory cytokine (e.g. TNFa and IL-6) production
in healthy volunteers. The results, including the LPS
challenge study results, support the continued clinical development
of R835 as a novel agent for the treatment of inflammatory and
autoimmune diseases.
Oral Presentations
Abstract
OP0133
Preclinical efficacy of R835, a novel IRAK1/4 dual
inhibitor, in rodent models of joint inflammation
Presenting
Author: Vanessa Taylor, PhD
Session: Immunity in rheumatic disease
Date: Thursday, June 4
Time: 10:45 AM CEST
Abstract OP0046
Targeting IRAK1 and 4 signaling
with R835, a novel oral small molecule inhibitor: a potential new
treatment for systemic lupus erythematosus
Presenting
Author: Chrystelle Lamagna, PhD
Session: Pathogenic insights transforming the treatment of
Sjögren's and SLE 2020 and beyond
Date: Wednesday, June 3
Time: 4:20 PM CEST
Poster Presentations
Abstract
THU0219
First-inhuman Study of Safety, Pharmacokinetics
and Pharmacodynamics of IRAK1/4 Inhibitor R835 in Healthy
Subjects
Presenting Author: Lucy
Yan, MD, PhD
Session: Rheumatoid arthritis - non biologic treatment and
small molecules
Date: Thursday, June 4
Time: 12:01 AM to 11:59 PM CEST
Abstract FRI0016
R835, a novel IRAK1/4 dual
inhibitor in clinical development, blocks Toll-Like receptor 4
(TLR4) signaling in human and mouse
Session: Innate immunity
in rheumatic diseases
Presenting Author: Vanessa Taylor,
PhD
Date: Friday, June 5
Time: 12:01 AM to 11:59 PM CEST
Abstract Publication
AB0058
Cell-type
specific regulation of IL-1R signaling by R835, a dual IRAK1/4
inhibitor
Session: Innate immunity in rheumatic
diseases
About R8351
The investigational candidate,
R835, is an orally available, potent and selective inhibitor of
IRAK1 and IRAK4 that has been shown preclinically to block
inflammatory cytokine production in response to toll-like receptor
(TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs
and IL-1Rs play a critical role in the innate immune response.
Dysregulation of these pathways can lead to a variety of
inflammatory conditions. R835 is active in multiple rodent models
of inflammatory disease, including psoriasis, arthritis, lupus,
multiple sclerosis and gout.
About Rigel (www.rigel.com)
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 immune and
hematologic disorders, cancer and rare 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 has been approved by the European Commission for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments and will be marketed in
Europe under the name
TAVLESSE® (fostamatinib).
Rigel's clinical programs include a Phase 3 study of
fostamatinib in warm autoimmune hemolytic anemia (AIHA); a
completed Phase 1 study of R8351, a proprietary molecule
from its interleukin receptor associated kinase (IRAK) inhibitor
program; and an ongoing Phase 1 study of R5521, a
proprietary molecule from its receptor-interacting protein kinase
(RIP) inhibitor program. In addition, Rigel has product candidates
in clinical development with partners Aclaris Therapeutics,
AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
Please see www.TAVALISSE.com for the full Prescribing
Information.
1 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 release contains forward-looking statements relating to, among
other things, Rigel's belief that the results of the LPS challenge
study support the progression of clinical development of R835 as a
novel agent for the treatment of inflammatory and autoimmune
diseases. 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 Annual
Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form
10-Q for the quarter ended March 31,
2020. 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.
IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
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SOURCE Rigel Pharmaceuticals, Inc.