- Recent data reinforce the anti-fibrotic activity of Aramchol
previously observed in a wide range of pre-clinical models, in
addition to the known effects in liver fibrosis
- The Open-Label Part of the ARMOR study met its objectives
demonstrating consistent anti-fibrotic effects at 48 weeks in NASH
patients and will be discontinued
- Cost reduction will allow rapid transition to anti-fibrotic
indications with high unmet need and faster development
pathways
- Company evaluating strategic alternatives to enhance
shareholder value
TEL
AVIV, Israel, May 17, 2022
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD)
("Galmed" or the "Company"), a clinical-stage biopharmaceutical
company for liver, metabolic, fibrosis and inflammatory diseases
announced today the Company's clinical development strategy will
expand into new anti-fibrotic indications to maximize the potential
of its lead compound, Aramchol while at the same time discontinuing
the Open Label Part of the Armor Study having reached its
objectives.
Expansion of Aramchol's clinical development to additional
indications provide a potentially faster development pathway for
regulatory approval based on three important factors: positive
results from the first part of the ARMOR study showing a consistent
antifibrotic effect, the timing of the initiation of the
Double-Blind Part with the improved formulation of Aramchol
Meglumine, and the pre-clinical data supporting the anti-fibrotic
activity of Aramchol in other fibrotic and pro-fibrotic
indications. The change aims to maximize the potential of Aramchol
with better use of Company resources.
The Company believes that the positive results obtained from the
Open Label Part already provide sufficient data with regards to
treatment duration, magnitude and consistency of effect, and taking
into consideration biopsy reading challenges and potential new
biopsy reading modalities, the Company concluded that the
Open-Label Part has met its objective. At this stage continuing the
Open Label Part as a standalone study is not expected to provide
additional data to justify its continuation.
In connection with the shift in development strategy, the
Company is initiating a comprehensive plan which includes a cost
reduction effort which will enable Galmed to develop Aramchol for
new fibrotic indications with high unmet need and faster
development pathways, while preparing for the registrational part
of the ARMOR study which is expected to commence in the second half
of 2023. To date, only limited anti-fibrotic drugs are approved or
are in development, most of which have restricting side effects.
The distinctive, direct anti-fibrotic mechanism of action of
Aramchol and long-term safety profile demonstrated so far in
advanced clinical studies make Aramchol a promising candidate for
such indications. Galmed expects to be able to leverage in part the
current clinical data to rapidly progress Aramchol into Phase 2 and
3 studies in new indications for use as monotherapy and
in-combination.
Allen Baharaff, Co-founder, President and CEO of Galmed
commented "Over the last year we have seen highly encouraging data
of Aramchol's anti-fibrotic effects. Together with the extended
patent for Aramchol meglumine to 2038, I am excited to prioritize
anti fibrotic indications for Aramchol. Galmed remains optimistic
that future years will see a breakthrough in the treatment of NASH
and that Aramchol will be among the leading future NASH drug
candidates. Simultaneously, Galmed is evaluating its strategic
alternatives and its structuring to best enhance shareholder value
and achieve its goals".
The Company has not stated a definitive timeline for completion
of the evaluation process and there can be no assurance that the
evaluation process will result in Galmed pursuing any strategic
alternative, or that a strategic alternative, if any, would be
completed successfully or at all. There can be no assurance that
the review will result in any transaction or other strategic change
or outcome. The Company does not intend to comment further until it
determines that further disclosure is appropriate or necessary.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Galmed's 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 COVID19 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; Galmed's expectations regarding
licensing, acquisitions and strategic operations; and the outcome
of any evaluation of Galmed's strategic alternatives. 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
on May 2, 2022, 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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SOURCE Galmed Pharmaceuticals Ltd.