R&D

BioMe is advancing four first-in-class, microbiome-based therapeutics that target distinct, high-burden diseases across the body. Collectively, these programs demonstrate BioMe’s ability to turn microbiome science into safe, scalable medicines with clearly defined mechanisms of action.

 

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BM109A first-in-class LBP targeting TMAU and CVD/CKD

Bacteria

BM109 (Patented)

Isolated from our proprietary stool bank

Mode of Action

BM109 produces a series of enzymes that completely decompose TMA and TMAO, an independent risk factor for CVD and CKD

Target indications

- TMAU (an orphan disease)
- Arteriosclerosis, Myocardial infarction, Stroke, Cerebral infarction, Heart failure
- CKD

Current treatments

The current medical landscape lacks effective interventions to reduce the blood levels of TMAO, highlighting significant unmet needs in this area.

Comments

A first-in-class, single-strain LBP that degrades TMA (Trimethylamine), lowering systemic TMAO (Trimethylamine N-oxide), a proven risk factor for cardiovascular and kidney diseases.
- Funded by the Korea Drug Development Fund (KDDF) with ~$ 2M.
- IND-enabling studies underway; Pre-IND meeting with the FDA completed.
- Demonstrated in vivo efficacy in diet-induced and stroke models.
- Awarded the 2025 Paul Dudley White International Scholar Award by the American Heart Association (AHA).
- Orphan Drug Designation (ODD) application filed to the FDA (March 2025).

BM101Airway viral infection

Bacteria

BM101 (Patented)

Isolated from the nasal cavity of a healthy individual

Mode of Action

BM101 secretes a heat-resistant immune-stimulating molecule.

Target indications

(i) Prevention of various respiratory viral infections,
(ii) Prevention of various hospital-acquired infections,
(iii) Vaccine sensitizer, (iv) immune-stimulating agent for cancer immunotherapy

Comments

BM101, in its heat-inactivated form known as parabiotics, is currently at preclinical stage.
The intranasal delivery of BM101 shows promise in providing protection against respiratory infections, particularly for individuals at high risk of infection.

BM111A novel, defined consortium of four fecal strains designed as an alternative to fecal microbiota transplantation (FMT) for treating antibiotic-resistant bacterial infections.

Bacteria

BM111, a consortium of fecal microbes (Patent filed)

Fecal microbes, safety profiles already confirmed
Four strains cultured in the same medium: enables cost-effective, standardized production,
FDA Pre-IND meeting completed

Mode of Action

(i) Restoration of dysbiotic state,
(ii) Physical decolonization of antibiotic-resistant pathogens

Target indications

VRE, CPE infections

Current treatments

While antibiotic stewardship programs aim to support patients with infections, their effectiveness is limited, highlighting significant unmet needs in disease management.

Comments

- Funded by the Celltrion through an Equity Investment.
- FDA Pre-IND meeting completed.
- Winner of the 2023 Microbiome Connect Asia Preclinical Competition.
- First-in-human study to begin in July 2025 at Severance Hospital (Yonsei University Health System)

BM107A “butyrate”-producing synbiotic targeting IBD and colon cancer, and addressing cognitive disorders via gut-brain axis modulation.

Bacteria

BM107 (Patented)

Isolated from our proprietary stool bank

Mode of Action

- BM107 (a food strain) + Tributyrin (three butyrate molecules bound to a glyceride backbone)
- Stable production of colonal butyrate

Target indications

(i) Individuals with high-risk polyps for colorectal cancer,
(ii) Irritable bowl syndrome (IBS)
(iii) Hyper-inflammatory conditions,
(iv) Constipation,
(v) Cognitive health

Comments

- Single Synbiotic, Multiple Indications approach
- Initial product approval as a functional food, followed by clinical trials targeting IBD, colon cancer, and cognitive disorders (Nutra-to-Pharma strategy)
- Co-developed with Trilliome, a Switzerland-based startup

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