Pipeline | HealthBiome

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BUSINESS

HealthBiome is going to contribute to the promotion of human
health through continuous research and development

HealthBiome is going to contribute
to the promotion of human health through
continuous research and development

Products

HB03

Akkermansia muciniphila Human intestinal strict anaerobic bacterial strain

Metabolic diseases

Degenerative brain
diseases

Cancer

Characteristics

Gram-negative, non-motile
Human intestinal commensal bacteria
(1~4% of stool mass, found in more than 75% people)
The first bacterium inoculated in the intestine during infancy

Isolated from a Korean intestinal microbiome

In the process of global patent application and registration

Whole genome analysis (KRIBB report 2021)

Non-(antibiotic resistance, antibacterial material production, pathogenic, toxin-related) genes
Non-gene transfer related plasmid, non-(mobile, prophage) genes
Anti-cancer & cognitive function improvement effects

HB02

Agathobaculum butyriciproducens Human intestinal strict anaerobic bacterial strain

Degenerative brain
diseases

Autism

Characteristics

Gram-positive, non-motile
Human intestinal commensal bacteria
The world’s first new species separated by HealthBiome Inc.
Excellent efficacy in treating and preventing degenerative brain diseases (Alzheimer’s disease, Parkin’s disease)
- 1) Report on the effect of treating Alzheimer model (Go et al. 2021)
- 2) Patent application of dementia and depression (US, EU, etc.)

Isolated from a Korean intestinal microbiome

In the process of global patent application and registration

HBP01

Akkermansia muciniphila Human intestinal strict anaerobic bacterial strain

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD)

Inflammatory Bowl Disease (IBD) is a disease that causes chronic inflammation in the gastrointestinal tract, develops from adolescents and accompanies symptoms such as abdominal pain, fever, diarrhea, and melena. In general, it is classified into two types. Ulcerative colitis is a type of diffuse non-specific inflammation of the large intestine that mainly invades the mucous layers and forms rubbles or ulcers, accompanied by various systemic symptoms including bloody diarrhea. Crohn's disease is an unknown granulomatous inflammatory lesion in which ulcers, fibrosis, stenosis, and lesions advance from the mucous membrane to the entire intestine discontinuously, accompanied by systemic symptoms such as abdominal pain, chronic diarrhea, fever, and malnutrition.

The anti-inflammatory efficacy of Akkermansia muciniphila strain was confirmed, The active ingredient (peptide) is separated from the strain and is being developed as a treatment for inflammatory bowel disease (IBD).

HB05P

Revolutionary Postbiotic for Muscle Strength Improvement

Discover HealthBiome's breakthrough pasteurized Akkermansia muciniphila strain isolated from maternal milk of healthy Korean women, clinically proven to improve muscle strength.

Understanding Akkermansia muciniphila

Abundant Gut Microbe

One of the most abundant members of the human gut microbiome, heralded as a next-generation probiotic agent due to its various roles in host health.

Effective Even When Pasteurized

Not only live strain but also heat-killed strain of A. muciniphila is known to maintain health benefits, making it ideal for stable supplement formulations.

Present in Human Milk

Scientific literature confirms A. muciniphila is naturally present in human milk, suggesting its importance in early human development.

Muscle Loss as we age

Sarcopenia, the continual loss of muscle mass and functions due to aging, represents one of the most widespread health problems in elderly populations worldwide. This condition significantly impacts quality of life and independence.

Until now, there are no medication approved for prevention or treatment of sarcopenia.

As a dietary supplement, HB05P has proven its efficacy in muscle strength improvement as well as the safety in various non-clinical and clinical studies. We believe the product will serve as an effective solution to mitigate such muscle challenge.

HB05P : A Unique Maternal Milk-Derived A. muciniphila strain

Based on scientific evidence that A. muciniphila is present in human milk, our research team collected breast milk samples from 30 healthy Korean mothers to isolate a novel strain

Source: Breast milk samples carefully collected from 30 healthy Korean mothers under strict IRB protocols.

Isolation: Advanced microbiological techniques used to isolate the specific A.muciniphila strain.

Deposit: The isolated strain was deposited to Korean Culture Center of Microorganism as a patented A. muciniphila strain of HB05 (KCCM12424P).

Pasteurization: HB05 undergoes pasteurization after cultivation to create HB05P, a postbiotics, maintaining beneficial properties while ensuring stability.

Comprehensive Research & Development

Our rigorous scientific approach ensures that HB05P is both safe and effective in muscle strength improvement. It began with laboratory studies and progressed through animal safety testing to human clinical trials, all conducted according to strict scientific and regulatory standards.

In Vitro → In Vivo → GLP Tox → Clinical Trials

Clinical Trial Outcome

A placebo-controlled randomized clinical trial involving 80 subjects aged over 60 has demonstrated that oral administration of HB05P (3.0X10^10 cells/day) significantly improves multiple aspects of muscle strength:

Lower Extremity Muscle Strength

Participants showed significant improvements in leg muscle strength (flexor and exensor in left and right leg, P<0.01).

Lower Extremity Muscle Power

Participants showed significant improvement in leg muscle power (flexor in left and right leg, P<0.05).

Grip Strength

Improved hand strength (right hand, P<0.05), a key indicator of overall muscle health.

Safety

No SAE (serious adverse event) and HB05P-related AE were reported

Hormonal Modulation Mechanism

The non-clinical and clinical studies revealed that HB05P works by modulating key hormones involved in muscle anabolism and catabolism:

IGF-1 (Insulin-like Growth Factor 1) which promotes muscle growth and repair
Myostatin, a protein that inhibits muscle cell growth and differentiation
Prealbumin, a sensitive biomarker for short-term protein synthesis and nutritional status
Follistatin which binds to and inhibits myostatin, promoting muscle growth
Atrogin-1 and MuRF1, crucial proteins in muscle catabolism (non-clinical)

Regulatory Status

US FDA NDIN

HB05P has received a no-objection letter from the US FDA for its New Dietary Ingredient Notification (NDIN) application, making it the first Akkermansia muciniphila strain to achieve this safety recognition (NDI 1438).

Korean MFDS Individual Recognition

HB05P completed Individual Recognition process with the Korean Ministry of Food and Drug Safety (MFDS) for approval as a health functional food with functional claim of "May help to maintain muscle strength which can be affected by aging" (Approval No 2025-71).

This regulatory recognition underscores the safety profile and scientific validity of HB05P, setting it apart from other Akkermansia-based products on the market.

The Future of Postbiotics Muscle Health

HB05P represents a significant advancement in addressing age-related muscle decline. As the global population ages, solutions that help maintain muscle function and strength become increasingly vital.

HealthBiome continues to explore additional applications of HB05P as well as to exploit health benefits of human commensal microbiome in its own collection in the strain library.

Products

Now on the market

Spindle Muscle+ — now available in the US

Spindle Muscle+ is a postbiotic designed for the gut–muscle connection. Powered by HealthBiome’s HB05P (Akkermansia MYO™), it supports healthy muscle function and has been shown in clinical research to increase muscle strength.

Active ingredient A. muciniphila HB05P (Akkermansia MYO™)
Dosing 1 capsule / day
Function Muscle strength & function
Regulatory FDA NDI (US)