Phases of Clinical Trials
Georgraphy of Biotechs
The Microbiome Drug Database™compiles the main biotechnology companies developing drugs and diagnostics through or from the microbiome, selected from Sandwalk’s Microbiome Players Database™ of 4,000+ companies active in the field of microbiome.
It is a tool designed for business development, M&A target scouting and technology analysis for companies and individuals interested in microbiome drug development.
Given the dynamic nature of the fast-growing microbiome industry, it is updated on a regular basis.
Only entities developing pharmaceuticals and/or diagnostics for human use from or through the microbiomeare included. Mainly human microbiome companies were introduced, however some companies are mining therapeutics from other ecosystems like water or soil microbiomes.
The following entities were excluded from the database:
- Universities, research institutes and research groups.
- Food or cosmetics companies.
- Brand owners (food, cosmetics).
- Service providers, including CMOs, CDMOs, preclinical or clinical CROs, microbiome sampling or sequencing companies.
- Developers of non-highly-selective antimicrobials.
- Developers of vaccines, oncolytic viruses and gene therapies as they are excluded from the scope of Live Biotherapeutic Products (FDA, 2016).
- Big pharmaceutical companies with which the original microbiome drug developers have partnered (these were included as “Partners” where applicable).
- Investors and grant-awarding entities.
- Health authorities or public entities.
Only human medicines research programs and products within the relevant companies were considered (e.g. animal health, food safety programs were excluded).
Microbiome (e.g. live bacteria) products currently regulated as pharmaceuticals in certain geographies (e.g. Saccharomyces boulardii in specific European countries) were not included.
- FMT(Fecal Transplant): this approach involves the transfer of more or less processed fecal microbiome material from a healthy donor to a diseased individual.
- Defined Consortia: based on treating the patient with a consortium of several microbial species. Whereas some of these products have emerged from further processing and refinement of FMT, some others have been designed rationally attending at ecological properties, metabolic capacities or other features.
- Single species(strain): a single type of microorganism is administered to elicit the beneficial effect.
- Phagesand viruses: using bacteriophages to kill bacteria and/or modulate the composition or activity of the microbiome, or mining for human viruses to find novel tools for human gene therapy (although the gene therapies themselves would be excluded from the scope of LBPs). Some viruses are native and others are engineered.
- GMOs(Genetically-Modified Organisms): engineering microbes to turn them into long-term drug delivery systems, or to expand or potentiate their metabolic activity.
- Molecules from the microbiome(also called postbiotics). Molecules (small molecules but also some biologics) originally mined from the microbiome and employed as therapeutic actives, with or without prior modification.
- Molecules for the microbiome: external chemicals (mostly small molecules, but also some biologics such as monoclonal antibodies) employed to therapeutically alter microbial activity and/or composition in the microbiome.
- Diagnostics, companion diagnostics and disease-monitoring technologies: microbial signatures and biomarkers have been linked with the risk of developing a disease or with its prognosis.
Some specific approaches may be borderline and were assigned to a single one for simplicity and ease of use. For example, genetically-engineered bacteriophages were systematically assigned to “Phages and viruses” rather than to “GMO microorganisms”
Different applications were systematically assigned to specific therapeutic areas.
- Infectious diseases: Clostridioides difficile, highly-selective antimicrobials against specific pathogens, urinary tract infections, implant-associated infections.
- Gut-Brain axis: Alzheimer’s Disease, Parkinson’s Disease, Autism, Depression.
- Oncology: stand-alone or adjuvant treatment for cancer, as well as supportive care for side effects of oncology treatment.
- Immune-mediated diseases: Inflammatory diseases, autoimmune diseases, multiple sclerosis, allergies, psoriasis.
- Metabolic diseases: obesity, diabetes, cardiovascular disease, inborn errors of metabolism.
- Gastrointestinal diseases: Irritable Bowel Disease, reflux and Gastroesophageal reflux disease, celiac disease.
- Dermatology: atopic dermatitis, acne.
- Other: women’s health, Sexually Transmitted Diseases, rare diseases, fertility.
Some diseases may be borderline and were assigned to a single one for simplicity and ease of use. For example, atopic dermatitis was assigned to “Dermatology”, whereas psoriasis was classified as “Immune-mediated diseases”.
Program and Application Names
Denominations were extracted from each company’s nomenclature. This includes some common abbreviations such as CDI for Clostridioides difficile infection and CD for Crohn’s Disease.
The world was divided into 3 areas:
- EU: Europe, including the UK
- US & CA: United States of America and Canada
- ROW: Rest of the World
Research phase is assigned according to the public information from the developer’s website or other sources:
- Pharmaceuticals were assigned one of the following categories: Discovery, Preclinical, Phase 1, Phase 2, Phase 3 and Market. In mixed phases (e.g. Phase 1/2 trials) the program was assigned the most advanced phase (Phase 2 in this example).
- When “Early stage development” or similar classification was provided by the developer, the stage “Discovery” was assigned
- Diagnostics were assigned one of the following categories: Discovery, Validation and Market.
All information shown is publicly available or has been provided with explicit permission by the companies concerned.