Rigel's R343 Did Not Meet Primary Endpoint in Asthma Study
SOUTH SAN FRANCISCO, Calif., Aug. 26, 2013
SOUTH SAN FRANCISCO, Calif., Aug. 26, 2013 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that R343, an inhaled SYK
inhibitor being evaluated as a potential therapeutic for patients with
allergic asthma, did not meet the primary or secondary endpoints in a recently
completed Phase 2 clinical study. The primary endpoint was the change in
pre-bronchodilator FEV1 (a measure of lung function) from baseline to dosing
completion at Week 8, comparing active doses to placebo. R343 was shown to be
relatively safe and well tolerated at both doses. In light of these overall
findings, the company has decided not to pursue this indication with R343.
"This was not the result we expected based on the collection of data we had
previously seen with R343 in this therapeutic area," said James M. Gower,
chairman and chief executive officer of Rigel. "Fortunately, we have a robust
portfolio of clinical and preclinical research programs to focus on that
includes Fostamatinib, R333 for discoid lupus erythematosus and R348 for dry
eye. We will be reviewing our portfolio and will discuss these plans in the
near-term," he added.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc.is a clinical-stage drug development company that
discovers and develops novel, small-molecule drugs for the treatment of
inflammatory and autoimmune diseases, as well as muscle disorders. Rigel's
pioneering research focuses on intracellular signaling pathways and related
targets that are critical to disease mechanisms. The company currently has
five product candidates in clinical development: fostamatinib, an oral SYK for
immune disorders; R333, a topical JAK/SYK inhibitor for discoid lupus, and
R348, a topical JAK/SYK inhibitor for chronic dry eye – both in Phase 2
clinical trials; and two oncology product candidates in Phase 1 development
with partners BerGenBio andDaiichi Sankyo.
This press release contains "forward-looking" statements, including, without
limitation, statements related to development plans and the planned disclosure
of the review of the portfolio. 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, our need for additional
capital in the future to sufficiently fund our 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, as well as other risks detailed from time to time in Rigel's
reports filed with theSecurities and Exchange Commission, including its
Quarterly Report on Form10-Q for thequarter ended June 30, 2013. 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
SOURCE Rigel Pharmaceuticals, Inc.
Press spacebar to pause and continue. Press esc to stop.