Full Press Release Details
MyBiotics to Collaborate in Development of Bespoke Microbiome Signature for Aramchol
Rehovot Israel, November 9, 2020 - 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."
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.
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.
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."
and Non-alcoholic Steatohepatitis (NASH)
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.
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.
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.
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.
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.
Guy Nehemya, Chief Operating Officer
Galmed Pharmaceuticals Ltd.