Current processing protocols are manufactured using open systems where the donated microbiota is exposed to the external environment. There are a number of required manual manipulations such as opening bottles and microbiota that require proper aseptic techniques and specialist controlled environments such as biosafety cabinets and cleanrooms. This means that scaling up the manufacture of more than minimally manipulated therapies presents several unique logistical and technical challenges. Furthermore, the majority of the human gut microbiota is composed of anaerobic bacteria. Reductions in anaerobic bacteria have been observed in patients suffering from diseases such as Inflammatory Bowel Disease. As current manufacturing methods involve open systems and aerobic environments, these likely compromise the viability of therapeutically active anaerobic bacteria.
To solve these challenges, we are developing and validating proprietary, streamlined semi-automated closed system technology that maintains the critical quality attributes of the microbiota without the need for cleanrooms and biosafety cabinets. This closed system enables our broader strategy of being able to enhance microbiota by adding and/or removing strains of bacteria in a precision manner.
Lack of microbial therapy uptake amongst patients could be limited by the fact that current methods of administration are invasive and are therefore not well suited for repeated dosing or frail patients. To solve these problems, EnteroBiotix is developing and validating a proprietary microbe delivery system (Microbe-DS) that enables site-specific delivery, patient-friendly administration and increased product shelf-life. Microbe-DS removes the need for the invasive medical procedures currently used to administer FMT and will also have the added benefit of simplifying the design of placebo-controlled clinical trials. Our long-term vision for Microbe-DS and our next generation diversity reconstitution platform is to allow patients to bank their own microbiota when they are healthy for reinstatement at a later date in a safe and convenient manner.
The microbiome is associated with an increasing number of unmet clinical needs, ranging from Inflammatory Bowel Disease to mental health disorders. We envision a world where patients can bank their own microbiota for reinstatement at a later date through a capsule after it has been enhanced through the addition or the removal of specific species of bacteria. We working with commercial and scientific partners to further develop this concept and developing and validating our platform are key steps on our journey to realise this vision.