Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced results
from interim analysis of the Phase 2 BRIGHT-SC proof-of-concept
study in 57 patients with biopsy-proven IgA Nephropathy.
Additionally, Anthera announced that its Phase 3 SOLUTION clinical
study with Sollpura® has closed screening and that the first
patients in the Phase 3 CHABLIS 7.5 clinical study with blisibimod
have been screened.
BRIGHT-SC – Blisibimod for IgA Nephropathy
Interim data from the BRIGHT-SC study (n=57) demonstrated a
positive trend in the reduction of proteinuria in blisibimod versus
placebo treated patients. While the numerical reduction in
proteinuria in blisibimod versus placebo treated patients at week
24 in the BRIGHT-SC study did not meet the predefined statistical
primary endpoint of complete or partial response, longer-term data
from the study demonstrated an increasingly large separation in
proteinuria favoring the blisibimod treated arm compared to placebo
through longer term observations.
Additionally, secondary biomarker data from the study, including
changes in total B cell counts and changes in immunoglobulins IgA,
IgG, and IgM, were highly consistent with previous studies with
blisibimod and demonstrated marked reduction after 8 weeks on
study. As a result of the increasing proteinuria effect after
24-week of dosing, and the clear demonstration of blisibimod’s
effect on immunological markers relevant to IgA nephropathy
including reductions of B cells, and immunoglobulins including IgA,
IgG and IgM, the company has elected to continue the study through
the 48-week time-point.
Blisibimod was generally well tolerated with the most common
adverse events being common cold, upper respiratory tract
infection, back pain, mild rash at the injection site.
Patients enrolled in the BRIGHT-SC study had a mean
proteinuria level of 2.4 grams and an estimated glomerular
filtration rate of less than 70 mL/min/1.73m2 – indicative of stage
2 chronic kidney disease per the national kidney foundation.
To date, two patients progressed to end-stage renal disease - one
in each of the blisibimod and placebo arms.
“While the effects of blisibimod on proteinuria in this small
proof of concept study did not reach statistical significance at
the 24-week time-point, the longer term effects on proteinuria
cannot be ignored. These effects are supported by clear
changes in B-cells, IgA, IgG and IgM, which represent a clear
impact of blisibimod on the patients underlying immune response,”
said Jonathan Barratt, MD, Reader in the Department of Infection,
Immunity & Inflammation, University of Leicester, Honorary
Consultant Nephrologist at Leicester General Hospital, and Head of
the Postgraduate Specialty School of Clinical Academic Training at
Health Education East Midlands. “We look forward to receiving the
final data set which will provide further insight into blisibimod’s
potential to benefit people with IgA nephropathy.”
“The positive trends in the longer-term proteinuria and
immunological data from this study are encouraging and provide a
strong rationale to continue the study. We remain optimistic
that, should these trends continue for all patients through
48-weeks, blisibimod could prove to be a meaningful therapy to slow
or prevent the progression of IgA nephropathy,” said James
Pennington, MD, Anthera’s Interim Chief Medical Officer.
Data from patients reaching 48-week time point of the study will
be presented later this year with the full dataset to be submitted
and presented at an upcoming scientific conference. This
final dataset will also include data regarding Time-Averaged
Proteinuria which has recently been identified as a predictor of
outcomes in IgA nephropathy.
SOLUTION – Sollpura® for Exocrine Pancreatic
Insufficiency
Anthera has closed patient screening for Phase 3 SOLUTION
clinical study evaluating the efficacy and safety of Sollpura®
(liprotamase), a conventional biotechnological pancreatic enzyme
replacement therapy (PERT), compared to an approved,
porcine-derived, enteric-coated product for the treatment of
exocrine pancreatic insufficiency (EPI). The Company expects
top-line efficacy data to be presented in the fourth quarter of
2016 and is anticipated to support marketing approval for Sollpura®
as a treatment for EPI. For more information on the SOLUTION
clinical study, please visit
http://www.anthera.com/clinical-studies/solution_study/.
CHABLIS 7.5 – Blisibimod for Systemic
Lupus Erythematosus
CHABLIS 7.5, Anthera’s second Phase 3 clinical study of the
efficacy and safety of subcutaneous blisibimod in subjects with
severe systemic lupus erythematosus with or without nephritis has
been initiated and successfully screened its first patient.
The primary objective of this study will be to evaluate the
clinical efficacy of blisibimod as measured by the Systemic Lupus
Erythematosus Responder Index (SRI) in a population of patients
who, despite corticosteroid use, continue to have clinically-active
systemic lupus erythematosus (SLE) as defined by SELENA-SLEDAI
score ≥10, with active inflammation defined as high
anti-double-stranded DNA and low complement – two serologic markers
which have repeatedly been associated with higher clinical response
with inhibitors of B-cell activating factor (BAFF). The study
requires that physicians taper their steroids based on attainment
of defined improvements in disease activity to a corticosteroid
dose of ≤7.5 mg/day prednisone. Patient eligibility for this study
is informed by responder traits identified in the Phase 2 study
with blisibimod as well as the large Phase 3 programs with other
BAFF inhibitors, belimumab and tabalumab. For more information on
the CHABLIS 7.5 study, please visit
http://www.anthera.com/clinical-studies/chablis_7-5/.
Results from the ongoing Phase 3 CHABLIS-SC 1 clinical study are
expected later this year. Recently the Data Safety Monitoring
Board (DSMB) of the blisibimod development program met to review
all data associated with the CHABLIS-SC1 and BRIGHT-SC clinical
studies. The DSMB recommended continuation of both studies
having found no concerning safety signals.
Anthera will host a conference call to further discuss the data
from the BRIGHT-SC clinical study.
Conference Call Access:
Date: Wednesday, June 29th, 2016
Time: 8:30 am Eastern Time
Conference ID: 42224216
Toll-Free Dial-In Number: (855) 226-3021
International Dial-In Number: (315)
625-6892
Contact Information:
Nikhil Agarwal of Anthera Pharmaceuticals, Inc.,
nagarwal@anthera.com or 510.856.5600 x5621
About BRIGHT-SC
The study enrolled 57 patients, 47 of whom completed assessments
through a minimum of 24 weeks. Patients with persistent proteinuria
(1-6 g/24hrs) prior to enrollment were randomized to receive either
blisibimod (300mg/wk for 8 weeks and 200mg/wk thereafter) or
matching placebo over background angiotensin converting enzyme
inhibitor (ACEi) or angiotensin receptor blocker (ARB). All
patients were treated with an optimal dose of ACEi or ARB for a
minimum of 90 days prior to randomization.
The primary endpoint of the study was the number of patients who
achieved a partial or complete response. A partial response is
defined as patients achieving proteinuria ≤1g/24hrs at Week 24. A
complete response is defined as follows: for subjects 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 subjects with baseline proteinuria >2g/24hrs,
achievement of proteinuria ≤1.0g/24hr OR a 50% reduction from
baseline at 2 consecutive visits. As this was a proof of concept
study the efficacy analyses are conducted on a smaller sample size
and a p value of <0.1 is considered to be significant.
About Anthera Pharmaceuticals, Inc.
Anthera Pharmaceuticals is a biopharmaceutical company focused
on developing and commercializing products to treat serious and
life-threatening diseases, including lupus, lupus with
glomerulonephritis, IgA nephropathy, and exocrine pancreatic
insufficiency due to cystic fibrosis. Additional information on the
Company 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 Quarterly Report on Form 10-Q for the quarter
ended March 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.
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