SOUTH SAN FRANCISCO, Calif.,
June 26, 2018 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
announced that it has initiated a Phase 1 study to assess safety,
tolerability, pharmacokinetics and pharmacodynamics of R835 in
healthy subjects. Rigel selected R835, a proprietary molecule from
its interleukin receptor associated kinase (IRAK) preclinical
development program, for human clinical trials. Preclinical
studies show that R835 inhibits both the IRAK1 and IRAK4 signaling
pathways, which play a key role in inflammation and immune
responses to tissue damage. Dual inhibition of IRAK1 and IRAK4
allows for more complete suppression of pro-inflammatory cytokine
release.
"Our approach to drug discovery and development at Rigel is to
identify molecules that modulate significant immune system
processes, potentially allowing for wide-ranging application across
different immune conditions or diseases impacted by the immune
system," said Raul Rodriguez,
president and CEO of Rigel. "We are excited to explore the broad
potential of R835 in autoimmune and inflammatory diseases, such as
psoriasis, lupus and others."
The Phase 1 study was initiated in the second quarter of 2018.
It is a randomized, placebo-controlled, double-blind trial in up to
91 healthy subjects, ages 18 to 55. The study design aims to assess
the tolerability and safety of R835 in both single ascending and
multiple ascending doses.
About R835
The investigational candidate, R835, is an
orally available, potent and selective inhibitor of IRAK1 and IRAK4
that blocks inflammatory cytokine production in response to
toll-like receptor (TLR) and the interleukin-1 family receptor
(IL-1R) signaling. TLRs and IL-1Rs play a critical role in the
innate immune response and dysregulation of these pathways can lead
to a variety of inflammatory conditions including psoriasis,
rheumatoid arthritis, inflammatory bowel disease and gout (among
others). R835 prevents cytokine release in response to TLR and
IL-1R activation in vitro. 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), an 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. Rigel's current
clinical programs include Phase 2 studies of fostamatinib in
autoimmune hemolytic anemia and IgA nephropathy. In addition, Rigel
has product candidates in development with partners BerGenBio
AS, Daiichi Sankyo, and Aclaris Therapeutics.
Please see www.TAVALISSE.com for full Prescribing
Information.
Forward Looking Statements
This release contains forward-looking statements relating to,
among other things, Rigel's plans to assess the safety,
tolerability and pharmacodynamics of R835 in healthy subjects and
to explore the potential of R835 in autoimmune and inflammatory
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 "plans", "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 of TAVALISSE;
risks that the FDA or other regulatory authorities may
make adverse decisions regarding TAVALISSE; 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 period ended March 31, 2018. 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: Raul Rodriguez
Phone: 650.624.1302
Email: ir@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
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SOURCE Rigel Pharmaceuticals, Inc.