Galmed and MyBiotics to Collaborate in Development of Bespoke Microbiome Signature for Aramchol

Collaboration Seeks to Enhance Response Rate and Identify Biomarker for Treatment of NASH and Fibrosis

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.

“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.”

commented Prof. Scott Friedman, Dean for Therapeutic Discovery, Chief Division of Liver Diseases, Icahn School of Medicine at Mount Sinai.

“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.