SOUTH SAN FRANCISCO, Calif.,
Jan. 30, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
announced updates from the clinical program of fostamatinib in
patients with chronic immune thrombocytopenic purpura (ITP).
Previously released results from the FIT Phase 3 clinical
studies (047, 048) of fostamatinib in chronic ITP demonstrated that
patients who responded to fostamatinib have a timely, robust, and
sustained response to treatment. As of September 2016, the open-label, long-term
extension study (049), was tracking the experience of 124 patients
who opted to receive treatment with fostamatinib after their
participation in either Study 047 or Study 048. Seventeen
patients who achieved a stable response to fostamatinib in the
parent studies enrolled in Study 049. As of September 2016, responders who enrolled in the
049 study had maintained a median platelet count of 106,500/μL over
this extended period of time. These patients have been on
fostamatinib treatment for a median of 16 months as of September
2016. In addition, there were now 41 out of 44 former placebo
patients who had been treated with fostamatinib for a minimum of 12
weeks. Of those, 22% (9/41, p=0.0078) achieved a prospectively
defined stable platelet response, which Rigel believes further
validates fostamatinib as a potential new treatment option for some
patients with this serious disease.
Rigel also announced its calculations of an overall response
rate for Study 047 and Study 048 by combining stable and transient
responders. The overall response rate to fostamatinib is 29%
(29/101) compared to 2% (1/49) for placebo (p=<0.0001). A stable
response was defined as a patient achieving platelet counts of ≥
50,000/μL on ≥ 4 of the 6 visits between weeks 14 and 24. In the
post-study analysis performed by Rigel, a transient response was
defined to include patients achieving at least 2 consecutive median
platelet counts over 50,000/μL during the trial without rescue, but
who did not otherwise meet the stable response criteria.
Response Rates for
Study 047 and Study 048
|
|
Response
|
Fostamatinib
|
Placebo
|
|
Stable
|
18/101
|
1/49
|
|
Transient
|
11/101
|
0/49
|
|
Overall
|
29/101
|
1/49
|
|
%;
p
|
29%
|
2%
|
p<0.0001
|
"We now have over 16 months of FIT Phase 3 data to analyze and
we're very encouraged that chronic ITP patients who respond to
fostamatinib are able to maintain a median platelet count of over
100,000 platelets/uL," said Raul
Rodriguez, Rigel's president and chief executive officer.
"These data continue to support our plan to submit a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for fostamatinib in chronic ITP in the first quarter of this
year."
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 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 data of the
Phase 3 clinical study with fostamatinib in ITP; 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;
Rigel's belief that fostamatinib may be an attractive alternative
for patients with ITP; 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 FDA may
disagree with our approach of presenting an analysis of combined
data from two trials, including one trial that did not meet its
primary endpoint, or may interpret our findings differently, which
could prevent us from submitting an NDA or result in the FDA not
approving any submitted NDA; 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.