Anthera Announces Completion of Dosing in the Phase 2 BRIGHT-SC Study of Blisibimod in Patients with IgA Nephropathy
April 10 2017 - 8:00AM
Anthera Pharmaceuticals. (Nasdaq:ANTH) today announced the
completion of dosing in the randomized, double-blind, placebo
controlled, Phase 2 BRIGHT-SC study of blisibimod in patients with
IgA nephropathy (IgAN). After Week 24, patients were given
the opportunity to continue blinded treatment for up to 104 weeks,
discontinue treatment but continue to be followed, or discontinue
from the study. Most patients, 42 of 57, completed at least
60 weeks of evaluation and 21 completed assessments through at
least 104 weeks. Anthera anticipates reporting top-line data
in Q3.
Interim analyses of blisibimod, conducted by an independent
statistician once all ongoing patients had completed Week 24 and
48, demonstrated a consistent slowing of proteinuria progression
and significant pharmacological effects on B cells and serum
immunoglobulins. Patients, investigators, and the sponsor
have remained blinded as to treatment assignment.
“We are encouraged by the trends on proteinuria seen in the
interim analyses and look forward to the unblinded results from the
BRIGHT-SC study," said William Shanahan, MD, Anthera's Chief
Medical Officer. "There is a significant unmet need for
patients with IgA nephropathy, for which there is no approved
therapy, and we remain optimistic that blisibimod may provide a
well-tolerated treatment option that targets disease pathology for
these patients.”
About BRIGHT-SC
The study enrolled 57 patients, 42 of whom completed at least 60
weeks of evaluation and 21 of whom completed at least 104 weeks.
Patients with persistent proteinuria (1-6 g/24hrs) despite
background optimized therapy with angiotensin converting enzyme
inhibitors (ACEi) or angiotensin receptor blockers (ARB), and
estimated glomerular filtration rate >30mL/min/1.73m2 were
randomized to receive either blisibimod (300mg/wk for 8 weeks and
200mg/wk thereafter) or matching placebo for up to 104 weeks and
were followed thereafter in the absence of study drug to assess
longer term outcome. All patients were treated with an optimal dose
of ACEi or ARB for a minimum of 90 days prior to randomization and
this therapy was continued throughout the trial as background
medication for all patients. Patients were not allowed to receive
corticosteroids for the treatment of IgA nephropathy within 3
months of screening.
The BRIGHT-SC study was originally designed as a two-part Phase
2/3 study with a target enrollment of 200 patients. Part A was a
24-Week study of the effects of blisibimod on proteinuria, and Part
B was an extension phase in which long term effects on the
prevention of end stage renal disease would be assessed.
After Week 24, patients had the option of continuing blinded
treatment for up to two years, discontinuing treatment but
continuing in the study under observation only, or discontinuing
from the trial. The primary endpoint of the study was
the number of patients who achieved a partial or complete response
in urinary protein excretion at Week 24. A partial response was
defined as achieving proteinuria ≤1g/24hrs, and a complete response
as follows: for patients with baseline proteinuria ≥1g/24hrs but
≤2g/24hrs, achievement of proteinuria ≤1.0g/24hr AND a 50%
reduction from baseline at 2 consecutive visits; for patients with
baseline proteinuria > 2g/24hrs, achievement of proteinuria
≤1.0g/24hr OR a 50% reduction from baseline at 2 consecutive
visits. Due to slow recruitment, enrollment was curtailed at 57
patients and the study was converted to a Phase 2 study. An
observed case analysis was conducted when all patients had the
opportunity to complete Week 24 and another at Week 48, and topline
results were previously announced for both analyses. Mean effects
by treatment group on proteinuria and certain measures of expected
pharmacology (circulating B cells and B cell subpopulations, serum
immunoglobulins) were analyzed and reported to Anthera by an
independent statistician, with the treatment blind maintained for
the patient, investigator, and sponsor personnel.
About IgA Nephropathy
IgA nephropathy (IgAN, also known as Berger's disease) is the
most common cause of primary glomerulonephritis worldwide,
occurring more frequently in Asia than in Europe or North America.
Patients express under-glycosylated immunoglobulin A1 (IgA1) which
is immunogenic and targeted by other immunoglobulins. The
resulting IgA-containing immune complexes are deposited in the
kidney, causing inflammation with consequent blood and protein
leakage into the urine. The disease typically progresses slowly,
but as many as 40-50% of adults will eventually develop
end-stage-renal disease and require dialysis or kidney transplant.
The current management of IgAN is non-specific treatment aimed at
blood pressure control and reduction of proteinuria with
angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin
II receptor blockers (ARBs); corticosteroids and immunosuppressive
therapy are used in some patients but benefits are uncertain.
About Blisibimod
Blisibimod is a selective peptibody antagonist of the B-cell
activating factor (BAFF) cytokine. BAFF is a tumor necrosis
family member and is critical to the development, maintenance and
survival of B-cells. It is primarily expressed by macrophages,
monocytes and dendritic cells and interacts with three different
receptors on B-cells including BAFF receptor, or BAFF-R, B-cell
maturation, or BCMA, and transmembrane activator and cyclophilin
ligand interactor, or TACI. The BAFF-R receptor is expressed
primarily on peripheral B-cells. Blisibimod consists of a novel
BAFF binding domain fused to the N-terminus of the Fc region of
human antibody. Blisibimod binds to BAFF and inhibits the
interaction of BAFF with its receptors.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious and
life-threatening diseases, including exocrine pancreatic
insufficiency and IgA nephropathy. Additional information on
Anthera can be found at www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to
future events or other non-historical matters, including statements
that are preceded by, followed by, or that include such words as
"estimate," "intend," "anticipate," "believe," "plan," "goal,"
"expect," "project," or similar statements, are forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. 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 Anthera's public filings with the SEC,
including Anthera's Annual Report on Form 10-K for the year ended
December 31, 2016. 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.
Investor Relations, Anthera Pharmaceuticals
ir@anthera.com
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