Live biotherapeutic products (LBPs) which target microbial communities in the skin and gastrointestinal (GI) and respiratory tracts are expected to offer hope to groups of irritable bowel syndrome (IBS) patients that currently have no US- or European Medicines Agency (EMA)-approved treatment options, according to a report by GlobalData.

The report highlighted the example of 4D Pharma’s Blautix, which could be the first product to treat patients with IBS that are experiencing both constipation and diarrhoea side effects (IBS-M). The company also noted that this is one of 23 microbiome-targeting therapeutics currently in development in the US and Europe for GI, dermatological and respiratory conditions.

“There is great potential for LBPs such as Blautix,” commented Chris Pilis at GlobalData. “IBS-M accounts for one third of IBS cases, according to GlobalData, and this drug is expected to claim an exclusive market share and provide substantial return on investment.”

However, the field of LBPs still lacks defined regulations. “Despite the recent re-definition of these drugs, there are no current guidelines specific to new drug applications (NDA) for LBPs,” Pilis continued. However, this is expected to be addressed in the coming years as more therapies approach late-stage trials.

The majority of the LBP drugs in the pipeline target GI indications. The four currently in late-stage Phase II trials are expected to launch in the next five to six years. This growing class of drugs is set to challenge existing treatments such as low-priced corticosteroids in atopic dermatitis or expensive biologics in ulcerative colitis. A payer interviewed by GlobalData noted that, if priced correctly for the indication, microbiome-targeting therapies could see good market access and strong uptake by patients.

“The microbiome is a space with ample opportunity for companies, as indicated by the lack of marketed products,” added Pilis. “There are plenty of strong candidates in the pipeline already, but, as these are largely being developed by small biotechnology companies, partnerships with larger pharmaceutical companies will eventually be required to break into the market. The field of microbiome-targeting therapies is still in its early days and the regulatory and competitive landscape is expected to be dynamic over the next decade.”

Key opinion leaders (KOLs) interviewed by GlobalData stated that they would use these products as add-ons to existing therapeutic regimens or as alternatives, should they make it to market. However, they remained reserved regarding long-term safety data and the maintenance of the therapeutic outcome after treatment.