#South Korea #Daejeon #Akkermansia muciniphila #HealthBiome #HB05P

HealthBiome Achieves Double Regulatory Success

HealthBiome Inc., a forefront company specializing in strict anaerobic microbiome research, has recently reached significant regulatory achievements concerning its postbiotic ingredient, HB05P. This innovative formulation has secured both the acknowledgment of a New Dietary Ingredient (NDI) from the U.S. Food and Drug Administration (FDA) and the approval of a functional ingredient by the Korean Ministry of Food and Drug Safety (MFDS). These milestones mark a pivotal moment for HealthBiome, setting the stage for a dual-market launch in 2026, which is expected to cater to the increasing global demand for health solutions targeting muscle maintenance in aging populations.

Regulatory Details

The FDA NDI acknowledgment for HB05P was granted after the successful completion of the NDI process. The ingredient's high-dose formulation of 3.0×10¹⁰ cells/day is noteworthy as it follows a previous low-dose approval received in December 2024—making HealthBiome the first company globally to gain NDI acknowledgment for two dosage levels of Akkermansia muciniphila, the beneficial bacteria at the core of this postbiotic. Meanwhile, the MFDS recognized HB05P for its effectiveness in potentially enhancing muscle strength, a significant claim that speaks to an aging population's health needs.

Notably, both the FDA and MFDS approved the same high-dose formulation, providing a consistent regulatory footprint across these critical markets.

What is HB05P?

HB05P is derived from Akkermansia muciniphila, a strain of beneficial bacteria identified in the breast milk of healthy Korean mothers. The ingredient is produced using a proprietary pasteurization method which ensures that it retains its functional benefits while vastly improving safety and stability. This method marks a departure from traditional live probiotic products, which can often be challenging to manage in terms of storage and safety.

With projections indicating that the number of individuals aged 60 and over will double to 2.1 billion globally by 2050, the functionality of maintaining muscle health is of paramount importance. HB05P addresses this pressing health demand through a novel approach that connects gut health with muscle well-being, reinforced by rigorous clinical trials that showcase its potential in improving muscle strength among the elderly.

Clinical Evidence

The efficacy of HB05P is backed by extensive clinical trials, including a 12-week randomized, double-blind, placebo-controlled study that involved 80 participants aged 60 to 80. This trial revealed statistically significant improvements in muscle strength in the participants receiving the HB05P formulation compared to those on placebo, marked by p-values ranging from 0.007 to 0.008 for primary endpoints. Additionally, beneficial changes in vital biomarkers such as increased insulin-like growth factor 1 (IGF-1) and prealbumin were observed, alongside a reduction in myostatin levels, a protein that inhibits muscle growth.

Safety results were equally impressive, with no notable adverse effects reported, underscoring the ingredient's compatibility and reliability for use in dietary supplements targeting muscle health.

Future Prospects

The FDA's NDI notification process is comprehensive, requiring extensive documentation of ingredient safety and efficacy, manufacturing processes, and dosing information. HealthBiome's success in this arena reflects its commitment to quality and safety in product development. As it gears up for commercial launches in 2026, the validation from both U.S. and Korean authorities will undeniably bolster its market entry strategy.

Furthermore, the MFDS’s functional ingredient approval aligns perfectly with the needs of Korea’s health functional food market, which currently exceeds $4 billion and is projected to grow significantly. This positioning illustrates HealthBiome's readiness to seize new opportunities with science-backed health solutions that resonate with consumer needs.

Conclusion

HealthBiome's journey is an exemplary case of how innovative science can lead to substantial advancements in health products. The regulatory achievements for HB05P not only highlight the company's dedication to improving muscle health in aging populations but also pave the way for future developments within the microbiome landscape. As discussions around health and wellness continue to evolve, HealthBiome stands at the forefront, ready to make significant contributions to the industry's narrative and consumer health outcomes.

To learn more about HealthBiome and its innovative products, visit HealthBiome.