TEL AVIV and REHOVOT,
Israel, Nov. 9, 2020 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (NASDAQ: GLMD) and MyBiotics Pharma Ltd.
announced today they have entered into a research and development
collaboration agreement to identify and optimize the selected
microbiome repertoire associated with the response to Aramchol. The
research will also focus on development of a standalone
microbiome-based treatment for non alcoholic steatohepatitis (NASH)
and fibrosis.
Under the collaboration, MyBiotics will employ its proprietary
SuperDonor technology in combination with its MyLiveIn
computational AI and screening platforms to identify and optimize
consortia of bacteria to reconstitute a NASH patient's gut flora in
order to enhance Aramchol's clinical efficacy and response
rate. The collaboration also aims to identify specific
microbial biomarkers for Aramchol based on macrobiome data
collected from Galmed's clinical studies that could serve as a
biomarker for Aramchol at early stage of treatment.
MyBiotics' microbiome therapeutic technology enables the design
of bespoke microbial consortia profiles based on MyBiotics' unique
culturing and fermentation capabilities. The microbiome therapeutic
technology is a nature-derived culturing and fermentation
technology which can be leveraged for single strains, consortia of
strains and whole microbiome solutions, integrated with a
computational AI platform. It increases the bacterial diversity
which can be leveraged for product candidates, and at the same time
produces bacteria which are more resistant to
gastrointestinal conditions, increasing bioavailability and
colonization. The microbiome therapeutic technology was validated
in multiple in-vitro and in-vivo models. MyBiotics' lead product
candidate for treatment of recurring clostridium difficile
infection (CDI), MBX-SD-202, is expected to enter Phase I clinical
trials in 2021.
Prof. Scott Friedman, Dean for
Therapeutic Discovery, Chief Division of Liver Diseases, Icahn
School of Medicine at Mount Sinai, commented, "Galmed's strategic
alliance with Mybiotics is both timely and exciting. The microbiome
is a major driver of NASH that is still untapped yet offers great
promise as a totally new approach to treat this challenging
disease. I look forward to this relationship evolving
successfully as we learn more about how to harness emerging
knowledge about the microbiome in pursuit of better strategies for
disease management."
"The collaboration, which aims to elevate the response rate of
Aramchol, is part of our overall plan to maximize Aramchol clinical
efficacy. This builds on our work to date that includes dosage
optimization (a PK study that demonstrated 300 BID resulted in
higher exposure of Aramchol by 53%), product optimization
(development of Aramchol meglumine with higher solubility and lower
variability) and treatment duration optimization," stated Allen
Baharaff, co-founder and CEO of Galmed. "Furthermore, with the
growing interest around the microbiome as a novel drug modality,
following the recent positive topline data from the SER-109 Phase 3
study, the combining of Galmed's proven track record in the NASH
space coupled with MyBiotics novel and proprietary knowhow and core
competences in the microbiome field, puts this collaboration at the
forefront of the microbiome NASH therapeutic development space,"
added Mr. Baharaff.
David Daboush, co-founder and CEO
of MyBiotics, commented, "The correlation of microbiome and
multiple clinical conditions has been investigated and published in
the last few years, particularly the correlation with NASH and
fibrosis, which is well recognized. We, at MyBiotics, established
our unique SuperDonor and MyLiveIn technologies that can be used
for developing a possible solution for NASH and fibrosis.
SuperDonor is an innovative alternative to FMT – it is safer, and
able to produce 100's treatments from a single stool
sample. We are very excited to enter into this collaboration
with Galmed, a leading company in the development of therapeutics
for NASH, and leverage our technology and knowhow to develop
products which could provide better solutions to NASH patients
around the world."
About Aramchol and Non-alcoholic Steatohepatitis
(NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid
bile acid conjugate, inducing beneficial modulation of
intra-hepatic lipid metabolism. Aramchol's ability to modulate
hepatic lipid metabolism was discovered and validated in animal
models, demonstrating downregulation of the three key pathologies
of NASH: steatosis, inflammation and fibrosis. The effect of
Aramchol on fibrosis is mediated by downregulation of steatosis and
directly on human collagen producing cells. Aramchol has been
granted Fast Track designation status by the FDA for the treatment
of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5%
of the U.S. population and an estimated 2% to 4% globally. It is
the fastest growing cause of liver cancer and liver transplant in
the U.S. due to the rise in obesity. NASH is the progressive form
of non-alcoholic fatty liver disease that can lead to
cardiovascular disease, cirrhosis and liver-related mortality.
About MyBiotics
MyBiotics discovers and develops microbiome-based products aimed
at restoring microbiome equilibrium for the therapeutics and food
markets. MyBiotics' technologies are effective for single microbes,
complex microbial consortia and whole microbiome products, and are
integrated with a computational AI platform which enables the
design of unique microbial consortia and whole microbiome profiles.
The Company's pipeline includes MBX-SD-201 and MBX-SD-202, for
Clostridium difficile Infection (CDI) developed for oral delivery,
that may become the first alternative for fecal microbiota
transplant (FMT). MBX-SD-202 is planned to enter Phase I clinical
studies in 2021. Additional products in the pipeline focus on
woman's health, gastro and oncology indications, as well as
probiotics and prebiotic programs.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Our lead compound, Aramchol™, a backbone drug candidate
for the treatment of NASH and fibrosis is currently in a Phase 3
registrational study. We are also collaborating with
the Hebrew University in the development of Amilo-5MER, a
5 amino acid synthetic peptide and plan to initiate a first in
human study by the fourth quarter of 2020.
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 12, 2020, 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. and MyBiotics Pharma Ltd