Anthera Pharmaceuticals Announces Additional Data from FRANCIS Study
- Varespladib showed early benefit in diabetic patient population -
HAYWARD, Calif., May 3 /PRNewswire-FirstCall/ -- Anthera
Pharmaceuticals, Inc. (NASDAQ:ANTH) , a biopharmaceutical company
developing drugs to treat serious diseases associated with
inflammation, today announced detailed results from a new biomarker
analysis of the FRANCIS study. FRANCIS examined the effects of
once-daily varespladib vs. placebo as an adjunct treatment to
high-dose atorvastatin and standard of care on inflammatory
biomarkers known to be predictive of secondary cardiovascular
events in patients with a recent acute coronary syndrome (ACS).
This new analysis examines the anti-inflammatory effects of
varespladib, an inhibitor of secretory phospholipase A2 (sPLA2), in
diabetic patients with a recent ACS.
This pre-specified analysis of diabetic patients demonstrated
treatment with varespladib was associated with early and
statistically significant improvements in inflammatory markers,
including C-reactive protein (CRP), low-density
lipoprotein-cholesterol (LDL-C) and varespladib's target enzyme,
sPLA2. Varespladib's treatment effect was incremental as compared
with 80mg of Lipitor (atorvastatin calcium) and standard of care.
These improvements were seen at all measured time points, up to and
including week 8, the primary endpoint of the FRANCIS trial. In
addition, interleukin-6 (IL-6), a short half-life pro-inflammatory
cytokine, which also is associated with increased cardiovascular
risk, demonstrated a statistically significant reduction through
week 4. The data have been submitted to an upcoming medical
conference.
"ACS patients with underlying diabetes are at an elevated risk
of cardiovascular events due to higher levels of inflammation. The
medical community has expressed interest in understanding the level
of impact varespladib could have on this difficult-to-treat patient
population," stated Colin Hislop, M.D., Anthera's Senior Vice
President of Cardiovascular Products. "These new data, combined
with data from the broader FRANCIS study population, further
support our hypothesis for the VISTA-16 Phase 3 study in high-risk
ACS patients with elevated levels of inflammation."
About Varespladib and sPLA2
Anthera Pharmaceuticals' varespladib is a potent and highly
selective inhibitor of secretory phospholipase A2 (sPLA2). Elevated
levels of sPLA2 have been implicated in a variety of acute
inflammatory conditions, including ACS and acute chest syndrome, as
well as chronic diseases, such as stable coronary artery disease
(CAD). In Anthera's FRANCIS clinical study in ACS patients,
varespladib (A-002) demonstrated marked improvements in independent
markers of cardiovascular risk including C-reactive protein, IL-6,
LDL-C and our target enzyme sPLA2. In February, the Company
received a Special Protocol Assessment (SPA) from the U.S. Food and
Drug Administration (FDA) for the VISTA-16 Phase 3 study for the
use of varespladib in high-risk ACS patients.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious
diseases associated with inflammation, including cardiovascular and
autoimmune diseases. Anthera has one Phase 3 ready clinical
program, A-002, and two Phase 2 clinical programs, A-623 and A-001.
A-002 and A-001 inhibit a novel enzyme target known as secretory
phospholipase A2, or sPLA2. Elevated levels of sPLA2 have been
implicated in a variety of acute inflammatory conditions, including
acute coronary syndrome and acute chest syndrome, as well as
chronic diseases such as stable coronary artery disease, or CAD.
Anthera's Phase 2 ready product candidate, A-623, targets elevated
levels of B-lymphocyte stimulator, or BLyS, which has been
associated with a variety of B-cell mediated autoimmune diseases,
including systemic lupus erythematosus, or lupus. For more
information, please visit www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to
future events or other non-historical matters are forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These include,
but are not limited to, statements relating to the anticipated
initiation of Anthera's clinical studies, anticipated duration and
expected results of these studies, and the progression of Anthera's
products through future stages of clinical development. These
forward-looking statements are based on Anthera's expectations as
of the date of this press release and are subject to certain risks
and uncertainties that could cause actual results to differ
materially as set forth in the Company's public filings with the
Securities and Exchange Commission, including Anthera's final
prospectus relating to its initial public offering filed pursuant
to Rule 424(b) under the Securities Act of 1933, as amended, on
March 2, 2010. Anthera disclaims any intent or obligation to update
any forward-looking statements, whether because of new information,
future events, or otherwise, except as required by applicable
law.
CONTACT: Juliane Snowden of Burns McClellan, Inc., jsnowden@burnsmc.com or
212.213.0006.
Source: Anthera Pharmaceuticals, Inc.
CONTACT: Juliane Snowden of Burns McClellan, Inc.,
+1-212-213-0006,
jsnowden@burnsmc.com, for Anthera
Pharmaceuticals, Inc.
Web Site: http://www.anthera.com/
Posted: May 2010
