Anthera Announces Positive Results from the Extension Period of the SOLUTION Study of Sollpura
March 29 2017 - 4:05PM
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the
findings from the Extension Period of the Phase 3 SOLUTION,
non-inferiority clinical study in cystic fibrosis patients with
exocrine pancreatic insufficiency (EPI). The Extension Period
was designed as an observational analysis of the long-term effects
of Sollpura and Pancreaze as it pertains to weight, height, BMI,
and safety.
“We are pleased to see the continued tolerability
and maintenance of weight and height in all of the Sollpura treated
cystic fibrosis patients with EPI during the Extension Period and
in particular, increases in weight and height in patients less than
17 years of age,” stated William Shanahan, Anthera’s Chief Medical
Officer. “The 20-Week data provides support that Sollpura may offer
patients an alternative to existing, porcine-based pancreatic
enzyme replacement therapies.”
During the Extension Period (Week 7 through Week
20), all patients treated with Sollpura maintained their weight at
56.4 kg-56.9 kg and all patients treated with Pancreaze maintained
their weight at 54.6 kg-54.8 kg. Both groups showed small
increases in height, with Sollpura increasing from 163.2 cm to
163.7 cm, and Pancreaze increasing from 160.6 cm to 160.8 cm.
A modest decrease in body mass index (BMI) was observed in both
treatment groups with Sollpura treated patients decreasing from
20.99 kg/m2 to 20.76 kg/m2 and Pancreaze treated patients
decreasing from 20.75 kg/m2 to 20.66 kg/m2. In pediatric
patients less than 17 years of age, the key age group for growth
and development, similar trends in weight and height were observed
in both treatment groups, as shown in the table below.
|
Patients <17 years of age |
|
Sollpuramean (standard deviation) |
Pancreazemean (standard deviation) |
Week 7 |
Week 20 |
Week 7 |
Week 20 |
n=15 |
n=15 |
n=20 |
n=19 |
Weight (kg) |
49.2 (13.8) |
49.7 (13.1) |
41.8 (15.1) |
41.5 (15.0) |
Height (cm) |
158.3 (13.8) |
159.8 (13.3) |
144.6 (16.6) |
145.0 (16.8) |
BMI (kg/m2) |
19.2 (2.8) |
19.1 (2.5) |
19.2 (3.6) |
19.0 (3.6) |
Sollpura and Pancreaze were generally well
tolerated with 40% and 54% of patients experiencing a treatment
emergent adverse event, respectively. Most of the difference
was comprised of a lower rate of infective pulmonary exacerbations
of CF in the Sollpura versus Pancreaze arm (9.2% vs. 20.6%) and
respiratory disorders (9.3% vs. 15.9%). Proportions of patients
experiencing mild, moderate, or serious events in the Sollpura
versus Pancreaze arm were 27.7% vs 41.3%, 9.2% vs 11.1% and 3.1% vs
1.6%, respectively. The rate of serious adverse events was
balanced at 4.6% for Sollpura and 6.3% for Pancreaze with no
discontinuations in either arm.
The Extension Period data concludes the Phase 3
SOLUTION trial. Anthera plans to initiate a Phase 3 trial,
RESULT, (Reliable Emergent Solution Using Liprotamase Treatment) in
1H 2017, with topline data anticipated at the end of 2017 or early
2018.
About SOLUTION
The Phase 3 SOLUTION study was designed to evaluate
the non-inferiority of Sollpura compared to approved,
porcine-derived, enteric-coated pancreatic enzyme replacement
therapy when administered at approximately equivalent doses to
patients with exocrine pancreatic insufficiency due to cystic
fibrosis. The study enrolled patients with exocrine pancreatic
insufficiency due to cystic fibrosis who were well controlled on
stable PERT therapy, as demonstrated by a coefficient of fat
absorption (CFA) of at least 80% at screening. The primary efficacy
variable evaluated the change from baseline in CFA following 7
weeks of therapy with either Sollpura or Pancreaze, an alternative
porcine PERT to that being taken during screening.
Individualized doses of Sollpura and the PERT comparator were
chosen to match the lipase units of pre-study PERT.
Adjustment of the study drug doses was allowed during the first 2
weeks of study based on clinical signs of malabsorption up to a
maximum of 150% of baseline but not to exceed 10,000 units/kg/day
of lipase. After the Week 7 CFA measurement, patients enrolled into
the SOLUTION study were followed through Week 20 for additional
assessments of safety and efficacy.
About RESULT
The Phase 3 RESULT study is designed to evaluate
the non-inferiority of Sollpura at individualized doses compared to
approved, porcine-derived, enteric-coated pancreatic enzyme
replacement therapy when administered to patients with exocrine
pancreatic insufficiency due to cystic fibrosis. The study
will enroll patients (N≈150) with exocrine pancreatic insufficiency
due to cystic fibrosis who are well controlled on stable PERT
therapy at screening, as demonstrated by a coefficient of fat
absorption (CFA) of at least 80%. The primary efficacy
variable will evaluate the change from baseline in CFA following
treatment through 4 weeks of therapy with either Sollpura or
Pancreaze. Patients randomized to Sollpura will begin at 125%
of the baseline porcine lipase dose and may undergo individualized
dose adjustments based upon gastrointestinal signs and symptoms up
to the lesser of two times the baseline lipase dose or 15,000
lipase units/kg/day in adults or 10,000 lipase units/kg/day in
patients ages 7 to less than 17. Anthera believes that this
optimized dosing paradigm will correct for differences in
solubility between the lipases in Sollpura and porcine PERTs in the
more acidic duodenal pH of patients with cystic fibrosis.
Patients randomized to Pancreaze will begin their dose at the
equivalent of their pre-study lipase units/kg/day. Patients
randomized to Sollpura will then be followed for an additional
20-Week extension period (total of 24 weeks on study) for
additional assessments of weight, height, BMI, and safety.
About Sollpura® (liprotamase)
Sollpura is a novel, non-porcine PERT containing a
proprietary, biotechnology-derived formulation of cross-linked
crystalline lipase, crystalline protease, and amorphous amylase
with broad substrate specificity, that has been designed for purity
(no potential for viral contamination), precise dose
standardization, resistance against proteolysis without enteric
coating, and stability in acid pH for potency of activity in the
proximal small intestine.
Sollpura represents potentially the first soluble,
stable and non-pig derived enzyme product to offer a solution to
people with EPI, including young children and adults, who are
either unable to swallow multiple pills or require gastric tubes in
order to maintain appropriate nutritional health.
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 due to cystic fibrosis, 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 Quarterly Report on Form 10-Q for the
quarter ended September 30, 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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