SOUTH SAN FRANCISCO, Calif.,
Jan. 5, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced that Raul Rodriguez, the company's president and
chief executive officer, will present a review of products in
development and a financial overview at the upcoming
35th Annual J.P. Morgan Healthcare
Conference in San Francisco on January 11, 2017, at 2pm PST (see webcast
details below).
Rigel's presentation will review the fostamatinib clinical
program, highlighting study data from the recently completed Phase
3 FIT clinical program in patients with immune thrombocytopenic
purpura (ITP). Rigel will also present initial Phase 2 study
results of fostamatinib in IgA nephropathy (IgAN), an autoimmune
disease of the kidneys, and provide an update on its pipeline
development.
"In 2016, Rigel completed its FIT Phase 3 clinical program in
chronic ITP. Based on these results, we believe that fostamatinib,
if approved by the FDA, could become an attractive new treatment
option for some patients with this serious disease," said Mr.
Rodriguez. "We're looking forward to submitting a New Drug
Application to the U.S. Food and Drug Administration (FDA) for
fostamatinib in chronic ITP in the first quarter of this
year. In addition, our recent results in IgAN are encouraging
and may provide an additional indication for fostamatinib," he
added.
Product Development Highlights
Fostamatinib in
ITP
- In August and October 2016, Rigel
reported results from the FIT Phase 3 studies of fostamatinib for
the treatment of ITP. The results of the Phase 3 clinical program,
including the long-term extension study, demonstrate that those
patients who respond to fostamatinib have a timely, robust, and
sustained response. Given the totality and consistency of these
Phase 3 results, the company expects to file a New Drug Application
in the first quarter of this year. Rigel has not received any
comments or questions on this plan from the FDA.
Fostamatinib in IgAN
- The first cohort in the Phase 2 study of fostamatinib in IgAN
was completed in various centers throughout Asia, the U.S. and Europe. This cohort evaluated the efficacy,
safety, and tolerability of a low dose of fostamatinib (100mg BID,
n=26; placebo n=12) as measured by change in proteinuria, renal
function, and histology (comparing the pre- and post-study renal
biopsies). The primary efficacy endpoint was the mean change of
proteinuria from baseline at 24 weeks. The study found that at 24
weeks fostamatinib was well tolerated with a good safety profile.
The initial data suggest a trend towards a greater reduction in
proteinuria in fostamatinib treated patients relative to placebo.
Further analysis of the Cohort 1 data, particularly the histology
review of the renal biopsies, as well as other secondary efficacy
endpoints, continues and will be presented later in 2017.
"IgA nephropathy, the most common
glomerulonephritis worldwide, is a disease that causes inflammation
and scarring of the kidney. Patients with IgA nephropathy are at
risk of serious complications of kidney dysfunction including high
blood pressure and renal failure. Currently, there is no specific
approved or consensus treatment for IgA nephropathy," stated
James A. Tumlin, M.D., Professor,
Internal Medicine and Nephrology, The University of Tennessee Health Science Center at
Chattanooga. "These Phase 2
results are very encouraging, particularly in that fostamatinib was
well tolerated and demonstrated a trend towards improving
proteinuria. We hope that future analyses and additional studies
will confirm the effectiveness of fostamatinib for the treatment of
IgAN."
- Rigel expects that the second cohort, evaluating a higher dose
of fostamatinib (150 mg) for IgAN, will finish enrollment in 2017
with full results in 2018. Rigel plans to seek a pharmaceutical
partner with a strong Asian market presence to collaborate in the
design and conduct of follow-on Phase 3 studies, as well as take
responsibility for the subsequent commercialization in that
territory.
Additional Product Development
- In 2016, Rigel initiated stage 1 of a Phase 2 proof-of-concept
study of fostamatinib in patients with autoimmune hemolytic anemia
(AIHA). Rigel expects to have results in 2017.
- In the fourth quarter of 2016, as part of our immuno-oncology
partnership, Bristol-Myers Squibb identified a TGF beta-receptor
kinase inhibitor molecule for IND-enabling toxicology studies,
resulting in a $3 million milestone
payment to Rigel.
- Rigel plans on selecting a molecule from its IRAK program for
preclinical development in 2017. It is expected that the program
will include clinical evaluation in immunology areas, such as for
lupus, gout and/or psoriasis.
Financial Update
Based upon preliminary estimates,
Rigel expects to end 2016 with approximately $74.8 million in
cash, cash equivalents, and short-term investments, which it
believes will be sufficient to fund its operations into 2018. These
operations include funding the NDA submission and activities
supporting the commercial launch of fostamatinib in the U.S. in
2018.
Rigel expanded its commercialization and operational
capabilities with the hiring and promotion of key executives.
Joining Rigel in 2016 are Eldon
Mayer, Executive Vice President and Chief Commercial
Officer, Ben Cadieux, Ph.D, Head of
Medical Affairs, Esteban Masuda,
Ph.D., Senior Vice President, Research, and Joseph Lasaga, Vice President, Business
Development and Alliance Management.
Webcast Details
To access the live audio webcast or
the subsequent archived recording, log on to www.rigel.com.
Please connect to Rigel's website several minutes prior to the
start of the live webcast to ensure adequate time for any software
download that may be necessary.
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 increased risk of severe bleeding
events that can result in serious medical complication, or even
death. Current therapies for ITP include steroids, blood
platelet production boosters (TPOs) and splenectomy. However, a
significant portion of patients do not do well on existing
therapies. As a result, there remains a significant medical need
for additional treatment options for patients with ITP.
Fostamatinib is an oral investigational candidate with a unique
mechanism of action designed to inhibit SYK kinase, a key
player in the immune process that leads to platelet destruction in
ITP. The FDA has granted Orphan Drug designation to
fostamatinib for the treatment of patients with ITP. Unlike
other therapies that modulate the immune system in different ways
or stimulate platelet production, fostamatinib may address the
underlying autoimmune cause of ITP by impeding platelet
destruction.
About IgAN
IgA Nephropathy (IgAN) (also known as
Berger's disease) is a chronic autoimmune disease associated with
inflammation in the kidneys that diminishes their ability to filter
blood. It is the most common primary glomerular disease affecting
an estimated 82,500 - 165,000 cases in the US, with a higher
prevalence in Asia. For as many as
25 percent of those living with IgAN, the disease results in
end-stage renal failure requiring dialysis or kidney
transplantation. Outside of angiotensin blockade (primarily for
blood-pressure control), there are no disease-targeted therapies
for IgAN. Pre-clinical data show that fostamatinib decreases SYK
activation in the kidney, reverses the inflammation in the
glomeruli and improves kidney function. The Phase 2 clinical
evaluation continues in 2017.
About Rigel (www.rigel.com)
Rigel
Pharmaceuticals, Inc. is a clinical-stage biotechnology company
dedicated to the discovery and development of novel, targeted drugs
in the therapeutic areas of immunology, oncology and
immuno-oncology. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. The company's
current clinical programs include clinical trials of fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor in a number of
indications. The company completed and reported results from two
Phase 3 clinical studies of fostamatinib in chronic immune
thrombocytopenia (ITP) in August and October
2016. Rigel is also conducting a Phase 2 clinical trial with
fostamatinib in autoimmune hemolytic anemia (AIHA) and a Phase 2
clinical trial for IgA nephropathy (IgAN). In addition, Rigel has
two oncology product candidates in Phase 1 development with
partners BerGenBio AS and Daiichi Sankyo.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
progress, timely execution and timing of reporting topline data of
the Phase 2 clinical study with fostamatinib in IgAN, the Phase 2
clinical study of fostamatinib in AIHA; the results of Rigel's
discussions with the FDA regarding its plans to advance
fostamatinib through the regulatory review process, including the
timing of and Rigel's ability to file a New Drug Application; the
management and advancement of Rigel's other clinical programs;
Rigel's belief that fostamatinib may be an attractive alternative
for patients with ITP; Rigel's ability to successfully seek a
pharmaceutical partner to collaborate in the design and conduct of
follow-on Phase 3 studies, as well as to commercialize
in Asia; statements relating to Rigel's cash position as of
December 31, 2016; the timing, amount
and sufficiency of Rigel's cash, cash equivalents, and short-term
investments; Rigel's ability to extend the value of Rigel's
pipeline into fields that are beyond its therapeutic focus, the
evaluation of fostamatinib for new treatment indications; and
Rigel's product pipeline and development programs. 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 "planned," "will," "may," "expect," 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, the availability of resources to
develop Rigel's product candidates, Rigel's need for additional
capital in the future to sufficiently fund Rigel's operations and
research, the uncertain timing of completion of and the success of
clinical trials, market competition, risks associated with and
Rigel's dependence on Rigel's corporate partnerships, risks related
to changes in estimated cash position based on the completion of
financial closing procedures and the audit of Rigel's financial
statements, 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
three months ended September 30, 2016. 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: invrel@rigel.com
Media Contact: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com
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SOURCE Rigel Pharmaceuticals, Inc.