Overview
4D Pharma develops Live Biotherapeutics, a novel class of drugs defined by the FDA as biological products containing live organisms like bacteria for preventing, treating, or curing diseases. The company uses its proprietary MicroRx platform to identify single-strain, naturally occurring gut bacteria candidates for oncology, respiratory, gastrointestinal, CNS, and autoimmune diseases. Clinical programs include trials in pancreatic cancer, asthma, COVID-19, and IBS, with manufacturing in Spain and collaborations like MSD for vaccines.
Frequently asked questions
- What are 4D Pharma's key capabilities in Live Biotherapeutics?
- 4D Pharma employs the MicroRx platform to rationally identify and develop single-strain, naturally occurring gut bacteria as oral Live Biotherapeutics for diseases including oncology, respiratory, GI, CNS, and autoimmune conditions, analogous to traditional drug development with animal models and clinical programs.
- What is the regulatory status of 4D Pharma's products?
- Products are regulated as biologicals by the FDA; the company has received approvals for Phase I trials in Parkinson's disease (MRx0005 and MRx0029), ongoing Phase I/II in cancer and asthma, Phase II in COVID-19 and IBS, with manufacturing at their Spain facility.
- What geographies does 4D Pharma operate in?
- Headquartered in Leeds, UK, with manufacturing in Spain; programs target global markets including US (FDA IND approvals, NASDAQ plans), international investors, and collaborations like MSD (Merck & Co.).