- Treatment with Aramchol 300mg BID resulted in a high rate of
subjects with fibrosis improvement using NASH CRN, paired ranked
reading and Artificial Intelligence (AI) quantitative digital
analysis.
- At week 48, both paired and AI evaluations identified more
subjects with fibrosis improvement (65% and 100% respectively)
compared to NASH CRN scoring.
TEL AVIV, Israel, April 28, 2022 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company for liver, metabolic and
inflammatory diseases announced today interim results from the
Open-Label Part of the ARMOR study showing fibrosis improvement
with Aramchol using multimodality histological assessment.
The Open-Label Part of the ARMOR study was designed to explore
the kinetics of histological outcome measures as a function of
treatment duration. Acknowledging the complexity, variability and
moderate reproducibility in liver pathology reading, this part was
also used to further assess different methodologies that may
support and improve fibrosis scoring, in preparation for the
registrational double-blind, placebo-controlled part of the study.
All slides were assessed using three histopathological reading
methodologies. A central pathology committee scored the biopsies
according to the conventional, formal, NASH CRN scoring system
(F1-F4).
Since paired reading may best reflect real-world pathological
assessment, the same central committee was also asked to perform a
ranked assessment (improvement/worsening/stable) of paired (pre and
post treatment) biopsies, scrambled and blinded to sequence. This
allows identifying fibrosis improvement that may be missed by the
formal scoring as well statistical quantification of change from
baseline.
An automated and continuous score of Fibrosis Composite Severity
(FCS) was established for the same slides using FibroNest™, a
quantitative Digital Pathology image analysis and artificial
intelligence (AI) method. This allows identifying fibrosis
improvement that may be missed by the formal scoring as well
statistical quantification of change from baseline.
Results of post baseline biopsies performed either at 24 weeks
or at 48 weeks from 46 subjects with NASH and F1-3 that received
Aramchol support the anti-fibrotic effect of Aramchol and reinforce
the favorable safety profile of Aramchol.
Biopsy Methodologies
|
24 Weeks
|
≥ 48
Weeks
|
|
N
|
%
|
N
|
%
|
|
All
|
26
|
100.0
|
20
|
100.0
|
|
|
Fibrosis Improvement
(1 stage or more) based on NASH CRN
|
7
|
26.9
|
8
|
40.0
|
|
Fibrosis Improvement
(Paired reading ranked assessment) based on
comparing individual
patients slides
|
11
|
42.3
|
13
|
65.0
|
|
Subject Fibrosis
Response (AI reading) using Fibronest's Phenotypic
Fibrosis Composite
Score (A responder is defined by an absolute
reduction of
> 0.3 units)
|
15
|
57.7
|
20
|
100.0
|
|
Treatment with Aramchol 300mg BID resulted in a high rate of
subjects with fibrosis improvement across the three pathology
reading methods. Both paired and AI evaluations identified more
subjects with fibrosis improvement, indicating greater sensitivity
to detect change. For all methods, a treatment effect was
larger at 48 compared to 24 weeks. AI analysis showed mean FCS
reduction was -0.62 (p=0.017) at Wk24 and -1.74 (p<0.0001) at
Wk>48.
Allen Baharaff, Co-founder, President and CEO of Galmed
commented "The results we are announcing today reinforce the robust
anti-fibrotic effects of Aramchol observed to date. The Open-Label
Part of the study continues to provide valuable information for
optimization of our clinical development program. Galmed
remains in the forefront of the scientifical efforts to re-assess
and improve biopsy reading methodologies, for future benefit of
NASH clinical trials".
About ARMOR Study
ARMOR is a Phase 3 study comprised of two-parts, an open-label
part and a randomized, double-controlled, placebo part, designed to
evaluate the safety and efficacy of Aramchol in approximately 200
sites in the U.S., Europe and
Latin America.
The first part, an open-label study, is designed to evaluate
treatment response kinetics, pharmacokinetics and safety of twice
daily administration of Aramchol 300mg in approximately 150
subjects with NASH and liver fibrosis stage 1-3 (F1 capped at 30
subjects), subjects with NASH who may or may not be overweight, and
subjects with NASH who may or may not have type 2 diabetes or be
pre-diabetic. Patients are randomized (1:1:1) into three groups
with post-baseline liver biopsy being performed at 24 weeks, 48
weeks, or 72 weeks, respectively. The open label part is being
conducted at approximately 50 selected sites in the U.S., and
around the world which have been less affected by the COVID-19
pandemic.
The second part, a randomized, double-blind, placebo-controlled
study, is designed to evaluate the safety and efficacy of twice
daily administration of Aramchol 300 mg to support regulatory
approval, with both a histology-based phase and a clinically-based
phase. As currently designed, a total of 2000 subjects with NASH
and liver fibrosis stage 2 and 3 who are overweight and are either
pre-diabetic or have type 2 diabetes are expected to be randomized
2:1 to receive Aramchol 300mg BID or matching placebo. In the
histology-based phase, we intend to treat 1000 subjects with
Aramchol or matching placebo for 72 weeks until the second biopsy.
The histology-based data is intended to serve as the basis for the
submission of a Sub-part H marketing authorization application
under regulatory provisions of accelerated/conditional
approval.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Their lead compound, Aramchol™, a backbone drug candidate
for the treatment of NASH and fibrosis is currently in a Phase 3
registrational study. Galmed is also collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide.
Forward-Looking Statements:
This press release may include forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to Galmed's objectives, plans and strategies,
as well as statements, other than historical facts, that address
activities, events or developments that Galmed intends, expects,
projects, believes or anticipates will or may occur in the future.
These statements are often characterized by terminology such as
"believes," "hopes," "may," "anticipates," "should," "intends,"
"plans," "will," "expects," "estimates," "projects," "positioned,"
"strategy" and similar expressions and are based on assumptions and
assessments made in light of management's experience and perception
of historical trends, current conditions, expected future
developments and other factors believed to be appropriate.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statements. Many factors could cause Galmed's actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements, including, but
not limited to, the following: the timing and cost of Galmed's
pivotal Phase 3 ARMOR trial, or the ARMOR Study or any other
pre-clinical or clinical trials; completion and receiving favorable
results of the ARMOR Study for Aramchol or any other pre-clinical
or clinical trial; the impact of the COVID-19 pandemic; regulatory
action with respect to Aramchol or any other product candidate by
the FDA or the EMA; the commercial launch and future sales of
Aramchol or any other future products or product candidates;
Galmed's ability to comply with all applicable post-market
regulatory requirements for Aramchol or any other product candidate
in the countries in which it seeks to market the product; Galmed's
ability to achieve favorable pricing for Aramchol or any other
product candidate; Galmed's expectations regarding the commercial
market for NASH patients or any other indication; third-party payor
reimbursement for Aramchol or any other product candidate; Galmed's
estimates regarding anticipated capital requirements and Galmed's
needs for additional financing; market adoption of Aramchol or any
other product candidate by physicians and patients; the timing,
cost or other aspects of the commercial launch of Aramchol or any
other product candidate; the development and approval of the use of
Aramchol or any other product candidate for additional indications
or in combination therapy; and Galmed's expectations regarding
licensing, acquisitions and strategic operations. More detailed
information about the risks and uncertainties affecting Galmed is
contained under the heading "Risk Factors" included in Galmed's
most recent Annual Report on Form 20-F filed with the SEC on
March 18, 2021, and in other filings
that Galmed has made and may make with the SEC in the future. The
forward-looking statements contained in this press release are made
as of the date of this press release and reflect Galmed's current
views with respect to future events, and Galmed does not undertake
and specifically disclaims any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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