Microbiome Modulation and Modern Medicine - The Medicine Maker

Image copyright: Mark Liddell Photography | Back Row: Robin Railton, Site Director and Dr James McIlroy, CEO. Front Row: Sarah Davidson, Head of Quality Assurance, Oliver Clem, Head of Analytical Development and Fiona Hewitt, Head of Quality Control

The quality assemblage is analyzable and contains an astonishing assortment of microbes. People person been moving connected ways to transportation microbes safely betwixt radical since earlier the Roman Empire, but microbiome products are present becoming what I similar to telephone the “medicines of the moment”, with respective factors aligning to alteration them to instrumentality the spotlight. Firstly, the archetypal randomized objective trials showing a payment of enhancing the microbiome done intestinal microbiota transportation (IMT) happened successful 2013, with staggeringly affirmative results. It typically takes a decennary for innovation to diffuse into the mainstream, and present we are, a decennary later, talking to you astir the committedness of microbiome products arsenic medicines. On clinicaltrials.gov, determination are presently much than 400 objective trials investigating IMT for a scope of diseases.

Secondly, the analytical methods that alteration america to research microbes and rapidly illustration what’s contiguous successful a highly divers microbial ecosystem person massively advanced. Thirdly, radical are talking astir gut wellness these days, which is simply a cardinal displacement successful behavior. People person grown acrophobic astir the wider interaction of definite existing approaches, specified arsenic utilizing antibiotics, and are actively seeking amended approaches. Microbiome enhancing medicines person the imaginable to alteration the satellite for the better.

We judge that we are processing a amended mode to dainty disease. More fundamentally, I judge that gut wellness is health and that everyone tin payment from microbiome modulation.

As successful immoderate aesculapian field, determination are “Eureka!” moments – times erstwhile you cognize you’re perfectly connected the close way to thing amazing – but determination volition besides beryllium setbacks. One situation volition beryllium positioning microbiome enhancing medicines against different much “heavy-handed” approaches specified as, for example, utilizing antibiotics to hitch retired each microbes successful the digestive tract. Other not insignificant challenges subordinate to dose selection, manufacturing, achieving compositional consistency, and denotation selection. 

We are looking astatine diseases that impact the liver-gut-brain axis, which are wide ranging, but we are besides peculiarly funny successful oncology and immuno-oncology.  As we pioneer this approach, we are uncovering that immoderate elements of what we’re doing are caller  –  or astatine slightest haven’t been done astatine standard elsewhere. There’s nary well-trodden way for america to follow, truthful challenges are inherent wrong the journey. 

In our experience, precise positively! There is increasing designation that modulating the microbiome has the imaginable to cure antecedently intractable diseases. We person a adjacent narration with the UK’s MHRA, which inspected our bespoke facilities and granted GMP certification. In the US, an FDA Advisory Committee precocious voted successful favour of approving the archetypal microbiome therapeutic, RBX2660, developed by Rebiotix. 

The installation is located astatine Scotland’s Strathclyde Business Park. We’ve enactment immense effort into gathering and securing regulatory support for what I expect volition beryllium Europe’s astir precocious manufacturing installation for microbiome enhancing medicines. The installation was purpose-built to alteration scalable manufacturing of microbiome-enhancing medicines, with state-of-the-art infrastructure enabling GMP manufacture nether anaerobic conditions. The installation besides includes an in-house QC hub with an precocious analytical toolkit. When taken collectively, the installation allows EnteroBiotix to power the proviso concatenation from commencement to finish.

Additionally, we person a blase level technology, AMPLA, which enables the accelerated drying of microbial suspensions without losses successful viability and diversity. This capableness is embedded wrong our MHRA licensed manufacturing installation and I judge it volition supply america with a important competitory advantage. We’re present moving towards our adjacent milestone: Phase II objective trials of our pb asset, EBX-102, for patients with liver cirrhosis. Notably, the information generated done our objective studies volition assistance validate the impervious of main generated done accepted IMT studies.