Developing and delivering live biotherapeutic products

The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in order to treat disease. Commenting on this new class of treatments is Duncan Peyton, Chief Executive Officer of 4D Pharma – a pharma company that develops LBPs.

NUMEROUS STUDIES have asserted that the gut microbiome has a far more complex role in health and disease than simply the functioning of the digestive system. Evidence for the brain-gut axis, for instance, describes bidirectional interactions between the gut microbiome and brain, suggesting that changes to the diversity of microbiota play a role in neurological and psychiatric diseases as diverse as depression, Alzheimer’s, Parkinson’s and autism spectrum disorder, as well as provide a potential avenue for their treatment.1

Dysbiosis (imbalance) in the gut microbiota has also been linked to respiratory diseases like asthma, cystic fibrosis, chronic obstructive pulmonary disease and tuberculosis; metabolic conditions such as obesity and type 2 diabetes; and autoimmune diseases, including inflammatory bowel disease, rheumatoid arthritis and systemic lupus erythematosus.2,3 Microbiota have even been shown to induce cancers, with Helicobacter pylori being the strongest risk factor for gastric adenocarcinoma;4 and modulate anti‑cancer drug efficacy, with elevated levels of Gammaproteobacteria having been shown to render gemcitabine (a chemotherapeutic drug) ineffective in cancers such as pancreatic ductal adenocarcinoma.5,6

To capitalise on this, an emerging therapeutic modality called live biotherapeutic products (LBPs) are being developed and investigated for a range of diseases.