Upcoming LBPs could be the answer for GI patients with no approved treatments, says GlobalData

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 patients that currently have no US- or EMA-approved treatment options, according to GlobalData. The leading data and analytics company highlights the example of 4D Pharma’s Blautix, which could be the first ever product to treat patients with IBS that are experiencing both constipation and diarrhea side effects (IBS-M), and notes that this is simply one of 23 exciting microbiome-targeting therapeutics currently in development in the US and 5EU* for GI, dermatological and respiratory conditions.

Chris Pilis, Pharma Analyst at GlobalData, comments: “There is great potential for LBPs such as Blautix. 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.”

According to the company’s latest report, ‘Thematic Research: Microbiome Targeting Therapeutics in Immunology’, one great barrier of LBPs is that the field still lacks defined regulations.

Pilis continues: “Despite the recent re-definition of these drugs, there are no current guidelines specific to new drug applications (NDA) for LBPs established in the 6MM**. 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, and four are in late-stage Phase II trials, including Blautix. These drugs are expected to launch within 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. Payors interviewed by GlobalData noted that, if priced correctly for the indication, microbiome-targeting therapies could see good market access and strong uptake by patients.

Pilis adds: “To date, there are still no marketed microbiome-targeting products, the only available therapy being experimental fecal microbiota transplantation. Big names such as Takeda and Johnson & Johnson have recently entered the field, either alone or in partnership with other companies. However, the development of microbiome-targeting therapies is currently dominated by small- to mid-size biotech companies.

“The microbiome is a space with ample opportunity for companies, as indicated by the current lack of marketed products. 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 were optimistic about the tolerability and efficacy profiles of the late-stage microbiome-targeting pipeline therapies. They said that they would happily use these products as add-ons to existing therapeutic regimens or even as alternatives should they make it to market. However, KOLs remain reserved regarding long-term safety data and the maintenance of the therapeutic outcome after treatment.”

* 5EU = France, Germany, Italy, Spain and the UK

** 6MM = US and 5EU


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