Authored by Cello Health, now part of Lumanity
Go back 3–5 years and ask people what the major disruptive trends in healthcare would be over the next few years and among the usual suspects: AI, personalized medicine, measurable tech, you would have surely heard the term ‘Microbiome’ thrown in for good measure. There was good reason for this excitement and huge projected potential – advances in microbiology, diagnostics (especially the information systems required to understand the power and impact our gut flora can have on our health) had recently opened new possibilities for treating a number of conditions across GI, GU, and metabolic conditions – even some cancers. A number of biotechs were also advancing the investigation of targeted Microbiome therapies, with Seres Therapeutics one of those leading the charge.
Here in 2020, time would appear to have cooled some of that early ‘hype’ around the Microbiome. To some extent this can be chalked up to more pressing issues, the ongoing COVID-19 pandemic has driven a lot more short-term thinking and the microbiome, like all emerging technologies, can be thought of as developing according to classic Gartner ‘hype cycles’ – the fading ‘peak of inflated expectations’ giving way to, well, reality, and the arduous work required to try and make the technology applicable to mass use. Seres in particular, however, suffered with the flat failure in 2016 of its key Phase II trial investigating its C. difficile infection (CDI) platform – raising questions of future of both the biotech and of wider interest in developing targeted Microbiome therapeutics.
That gloomy outlook may have changed this week with Seres claiming a huge Phase III comeback, leading to a shares spike. In this second crack at proving the benefits of SER-109, a consortium of purified bacterial spores of multiple Firmicute species, the experimental treatment had an 11.1% CDI recurrence rate compared to 41.3% in the placebo group – apparently good enough to take straight to the US Food and Drug Administration (FDA) to seek approval. If that approval process goes forward, it will certainly be interesting in the precedents it sets – questions will be raised as to how Phase II failure could lead to such a significant Phase III result. Discussions between Seres leadership and the Endpoints News team may hint at careful population analysis from the Phase II trials, leading to an older population being selected for the Phase III.
To what extent this news drives interest in, and investigation of, the Human Microbiome as a therapeutic modality is too early to say for certain – but in the short term this has certainly caused investors to flock to Seres, providing it with what will surely be welcome capital. The discourse over next few days as various stakeholders absorb this news could be an early indicator as to whether this is indeed indicative that we are emerging from the ‘trough of disillusionment’ (to quote the hype cycle) when it comes to the Microbiome. Even if it is, we know the Microbiome is a diverse space in terms of potential therapeutic interventions and modalities. For companies considering entering the Microbiome space in near term to reap the potential mid-long term rewards, a thorough landscape analysis driving robust scenario planning, will be a must in order to make confident, internally-aligned investment decisions!
“Based on our prior discussions with the FDA, we believe this trial should provide the efficacy basis for submitting an application for product approval….Our results represent the first-ever positive pivotal clinical study results for a targeted microbiome drug candidate.”Seres Therapeutics CEO, Eric Shaff