Microbiome Medicinal Products: Concept to Commercial
Scendea Authors:
Aarti Pattni, Dr Maria Beatrice Panico & Zeb Younes
Back Bay Authors:
Dr Peter Bak, Dr Brianne Sullivan & Crystal Hsu
A growing body of pre-clinical and clinical research has implicated the influence of bacteria on human health which over the last decade led to a flurry of venture capital and biopharma interest. The collection of non-human cells living within the gut, skin, and other tissues (collectively referred to as “microbiota” or the “microbiome”) has a profound influence on maintaining normal physiologic function (homeostasis).
Disruption of this balance (“dysbiosis”) can influence the development and progression of pathologic disease states such as cancer and autoimmunity. As the FDA has recently approved the first two bacterial based products for the prevention of Clostridioides difficile infections (Ferring’s Rebyota and Seres’ Vowst), Scendea and Back Bay Life Science Advisors reviewed the current regulatory issues for biotherapeutics as well as the state of investment and development in therapeutic areas beyond gut disease.