Development of synthetic biotics as treatment for human diseases

Advances in synthetic biology have allowed the generation of strains of bacteria that are genetically altered to have specific therapeutic benefits. These synthetic biotics, also widely referred to as engineered living therapeutics, have tremendous potential as a new therapeutic modality, and several have advanced into the clinic and human testing. This review outlines some of the unique attributes of synthetic biotics as well as some of the challenges in their development as prescription products. Regulatory considerations are discussed, and a case study of a program that has advanced into Phase 2 testing is provided: SYNB1618 for the treatment of PKU.

Automated summary

Advancements in synthetic biology have led to the creation of genetically modified bacteria strains with specific therapeutic benefits, known as synthetic biotics. These engineered living therapeutics show great potential as a novel therapeutic modality, although they face challenges in their development as prescription products.