Hello, skin microbiome enthusiasts. 

I have completed two proposals that I’ve been developing over the past few months. In the process of writing these proposals, I delved into various resources to gain an overview of the research focused on developing probiotic-based drugs. This interest stemmed from understanding my competition and learning from others’ work to lay the groundwork for my concept. Unfortunately, the findings were somewhat disheartening. There are over 2,200 registered clinical trials globally, with approximately 18% in phase IV. In the U.S., there are more than 370 registered clinical trials where probiotics are used as novel medicine, yet to date, no probiotic has been approved by the FDA as a drug. A few years ago, the FDA issued a statement recognizing the potential of probiotics and their health benefits but cited the lack of consistent clinical outcomes as the reason for not approving them as new drugs. 

From my professional standpoint, the issue is more complex than the FDA’s brief statement suggests. Most clinical trials do not progress beyond phase 2, which is the stage where final scalable formulation is required for trials involving several hundred patients. Probiotics are challenging to formulate, requiring both shelf stability and the retention of physiological properties upon usage. The unknowns include not just the quantity of live cells needed but also how to measure that viability in the final application. Viability does not necessarily equate to efficacy; perhaps other metrics and key performance indicators are needed. 

While these questions are crucial, most companies concentrate solely on strain and drug discovery, leaving those like fafabiotic, which focus on formulation, in a significant minority and with a very small share of funding. We hope to change this landscape, and I am optimistic that we will succeed, thereby paving the way to unleash the potential of probiotics in medicine.

Until next blog, Cheers