The agreement will see MyBiotics’ SuperDonor technology and Artificial Intelligence (AI) powered screening platforms attempt to model a NASH patient's gut flora to assist the compound’s efficacy and response rate.
Galmed’s compound, Aramchol is a novel fatty acid bile acid conjugate that in studies has proved capable of influencing lipid metabolism in the liver – a function that is impaired in NASH.
“Galmed's alliance with Mybiotics is both timely and exciting,” comments Professor Scott Friedman, Dean for Therapeutic Discovery, Chief Division of Liver Diseases, Icahn School of Medicine at Mount Sinai.
“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 agreement, which will also look into developing a standalone microbiome-based treatment for NASH and fibrosis, also aims to identify microbial biomarkers for Aramchol.
Here, macrobiome data collected from Galmed's clinical studies will be the focus, potentially serving as a biomarker for Aramchol at early stage of treatment.
According to Allen Baharaff, co-founder and CEO of Galmed, the collaborations efforts to elevate Aramchol’s response rate builds on the Israel firm’s work that includes dosage, product and treatment duration optimisation.
"With the growing interest around the microbiome as a novel drug modality, the combining of Galmed's proven track record in the NASH space coupled with MyBiotics knowhow in the microbiome field, puts this collaboration at the forefront of the microbiome NASH therapeutic development space," he adds.
Encouraging data recently released from another microbiome-related study serves to increase interest in this emerging therapeutic area.
Last month, Seres Therapeutics detailed positive Phase 3 results that showed its microbiome therapeutic SER-109 could reduce Clostridium difficile infection (CDI) recurrence at 12 weeks post-treatment.
Additional findings pointed to SER-109 administration as having a similar efficacy when sorted by age groups (i.e., > or <65 years) or prior antibiotic received (i.e., vancomycin or fidaxomicin).
SER-109 is a group of purified Firmicute bacteria in spore form, manufactured by fractionating targeted bacteria from the stool of healthy human donors with further steps to inactivate potential pathogens.
Clostridium difficile focus
MyBiotics’ MBX-SD-202 is the firm’s lead candidate for treatment of recurring CDI and is expected to enter Phase I clinical trials in 2021.
The candidate was identified by its microbiome therapeutic 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 used to identify product candidates, whilst producing bacteria which are more resistant to gastrointestinal conditions, increasing bioavailability and colonisation.
MBX-SD-202 was the focus of €2m ($2.3m) funding by the European Union (EU) last month to develop technology capable of delivering personalised probiotics to tackle gut-related diseases.
The award, given out as part of the EU’s Horizon 2020 Program, was also earmarked by the firm to tailor probiotic interventions to recover damaged gut microbiota and develop multi-strain libraries in preparation.
Improving current probiotics
“MyBiotics' technology enables the transformation of beneficial bacteria to clinically efficient products,” said David Daboush, CEO of MyBiotics Pharma.
“Our proprietary, microbial nature-driven, enhanced technology combined with microbes with potential health benefit, holds the potential to greatly improve existing probiotic solutions.
"The Horizon 2020 Program grant is a significant validation and strong vote of confidence in MyBiotics and will support our development of more effective, next generation probiotics," he added.
Commenting on the collaboration with Galmed, Daboush adds the deal to develop products could provide ‘better solutions to NASH patients around the world.’
"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 recognised.
“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 of treatments from a single stool sample.”