REHOVOT, Israel, Jan. 24, 2022 /PRNewswire/ — MyBiotics Pharma Ltd, a clinical stage microbiome therapeutics company, today announced the successful completion of Phase I clinical trial of MBX-SD-202 whole microbiome treatment in healthy volunteers.
MBX-SD-202 has been developed and manufactured using the company’s SuperDonor™ whole microbiome culturing technology, which enables standardized and scalable reproduction of desired whole microbiome origins. MBX-SD-202 is intended to treat recurrent and severe cases of Clostridioides difficile infection for patients that were already treated with antibiotics. C. diff, is an intestinal bacterium that can cause serious infection, with a recurrence rate of more than 25% following antibiotic treatment, and associated with approximately 30,000 deaths annualy in the US alone.
The positive outcome of the clinical trial confirms the safety of MBX-SD-202 in healthy volunteers, supports further development of the SuperDonor™ technology and serves as a steppingstone to the discovery of a wide new range of safe and reproducible microbiome restoration therapies.
About the trial
MBX-SD-202, an encapsulated investigational drug, was administered orally to healthy volunteers. The subjects were divided into 3 dose groups treated in an incremental manner; each received a single administration of MBX-SD-202 capsules. The subjects were monitored for 30 days with in-person visits consisting of physical examination, lab tests and stool sampling.
No serious adverse events were reported. No clinically significant impact on lab tests, general health, or gastrointestinal symptoms were observed.
The results demonstrate the safety of MBX-SD-202, in all 3 studied doses, and support the next steps in its clinical development program.
David Daboush, CEO of MyBiotics, commented on the MBX-SD-202 study: “We are excited to have completed the first human test of our scalable whole microbiome SuperDonor™ technology. The trial was successful and enables us to continue with our clinical program as planned, advancing our pipeline of C. diff treatment and potentially additional indications already in development. Now that its safety has been confirmed in healthy subjects, we look forward to applying the SuperDonor™ technology to multiple indications, such as oncology, in the company’s clinical pipeline.”
MyBiotics plans to continue clinical development of MBX-SD-202 for recurrent C. diff and closely related medical indications during 2022 and 2023.
MBX-SD-202 is an investigational drug for the treatment of recurrent and severe cases of C. diff infection in patients already treated with antibiotics. It is based on the disruptive proprietary SuperDonor™ technology, that enables duplication and production of complex live microbial populations derived from biological samples, e.g., donated fecal samples (as used for fecal microbiota transplantation [FMT]), in a safe, controlled and scalable manner, while maintaining high microbial similarity to the original sample.
Currently, FMT is used to treat C. diff and its efficacy has been investigated in other medical indications. However, FMT has several limitations, such as high cost, donor-dependency, product consistency, and potential safety concerns.
Moreover, combined with MyBiotics’ computational platform, the SuperDonor™ technology can be used to identify, design and create standardized and scalable alternative to FMT treatments having a pre-selected target microbial profile. Such flexible functionality potentially makes the SuperDonor™ technology an important enabler of larger scale whole microbiome clinical trials targeting additional important disease indications.
MyBiotics is a clinical stage company that discovers and develops microbiome-based products aimed at restoring microbial equilibrium for the biopharmaceutical and supplement markets. MyBiotics’ technologies are applicable for development of single strains, complex microbial consortia, and whole microbiome-based products. These technologies are integrated with AI and a machine learning computational platform that enable the design of unique microbial consortia and whole microbiome profiles. Additional products in the pipeline focus on woman’s health, gastrointestinal, and oncology indications, as well as probiotics and prebiotic programs.
For additional information, please visit www.mybiotics-pharma.com or connect with us on LinkedIn.
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SOURCE MyBiotics Pharma Ltd.