Metro International Biotech Begins Phase 1a Trial of NAD Booster MIB-725
Metro International Biotech, LLC (MetroBiotech), a pioneering company in the development of next-generation therapies for age-associated diseases, has officially launched its first-in-human clinical trial for MIB-725, a novel investigational drug designed to enhance cellular NAD+ levels. The initiation of this Phase 1a study marks a significant step forward in the company’s ambitious pipeline aimed at targeting aging and its associated pathologies at the molecular level.
Based in the biotechnology hub of EdenRoc Sciences, MetroBiotech is developing a series of NAD+ precursor compounds to tackle chronic diseases of aging. The company’s latest advancement—MIB-725—represents a new class of proprietary small molecules specifically engineered to optimize nicotinamide adenine dinucleotide (NAD+) biosynthesis. NAD+ is a critical coenzyme involved in numerous cellular processes, including mitochondrial function, DNA repair, gene expression, and cellular metabolism. Age-related NAD+ decline has been implicated in a wide array of degenerative conditions ranging from metabolic disorders to neurodegeneration and chronic kidney disease (CKD).
The Phase 1a clinical trial, currently underway, is structured as a randomized, double-blind, placebo-controlled single ascending dose (SAD) study and is being conducted at a leading clinical research site. Its objective is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), metabolic profile, and preliminary biological activity of MIB-725 in healthy volunteers. The data collected from this early-stage trial will provide essential insights that will shape the design of future studies, including planned multi-dose investigations in aging-related indications such as CKD.
Cohort 1 Dosing Initiated Without Dose-Limiting Toxicities
According to MetroBiotech’s announcement, the first cohort of subjects has already begun receiving MIB-725, and four out of eight patients have been dosed without any observed dose-limiting toxicities (DLTs). This is an encouraging early safety signal, laying the groundwork for further dose escalations within the study. Once all patients in the initial cohort have been safely dosed, the clinical team will progress to higher dosing levels in subsequent cohorts. The careful dose-escalation strategy will enable researchers to characterize the compound’s safety margins while collecting vital PK/PD data.
Should this single-dose Phase 1a study yield positive results, MetroBiotech intends to initiate a follow-up Phase 1b multiple ascending dose (MAD) trial at the same investigative site. The subsequent trial will help establish a comprehensive understanding of the compound’s safety and tolerability over repeated administration, and it may offer the first glimpse of potential therapeutic signals.
Addressing the NAD+ Deficit in Aging: A Strategic Approach
MIB-725’s development is rooted in a growing body of evidence supporting the therapeutic relevance of NAD+ biology. NAD+ levels naturally decline with age and in response to chronic stressors such as inflammation, oxidative damage, and metabolic dysregulation. These changes contribute to mitochondrial dysfunction, cellular senescence, and the pathogenesis of several age-related diseases. As such, restoring NAD+ homeostasis is increasingly seen as a viable strategy to mitigate aging-related deterioration.
What distinguishes MIB-725 from earlier NAD+ boosters like nicotinamide riboside (NR) or nicotinamide mononucleotide (NMN) is its unique molecular structure, which has been engineered to enhance bioavailability, target tissue delivery, and metabolic conversion efficiency. Preclinical studies in animal models have demonstrated MIB-725’s superior NAD+ boosting capacity compared to first-generation compounds, alongside a favorable safety profile.
“Commencement of Phase 1 testing of our novel NAD booster is a key step in our vision of developing the potential of a family of NAD precursor compounds optimized for particular therapeutic indications,” said Dr. David Livingston, president and chief scientific officer of MetroBiotech. “The current single ascending dose trial of MIB-725 will create our first safety, PK/PD, and metabolic database for this unique molecule, and is an important milestone in our company’s clinical development program.”
Dr. Livingston also emphasized that the data generated from this trial will inform MetroBiotech’s broader clinical strategy, particularly in identifying lead compounds for various disease states. “We believe this trial will inform the compound expansion stage of our ongoing clinical trials and may allow us to obtain initial evidence of clinical activity as the program continues to advance,” he added.
A Focus on Age-Related Kidney Disease
One of the lead indications under consideration for MIB-725 is chronic kidney disease (CKD) associated with aging, a condition with significant unmet medical need. CKD affects millions worldwide, with age being one of the most significant risk factors. The progressive nature of kidney function decline with age is closely linked to reduced mitochondrial function, increased oxidative stress, and chronic inflammation—all of which may be modulated by NAD+ boosting strategies.
MetroBiotech aims to use MIB-725 and related compounds to restore metabolic balance in renal tissue, improve cellular resilience, and slow disease progression in CKD patients. Future clinical trials, building on the safety data from the current study, will likely explore these disease-modifying effects in relevant patient populations.
A Growing Market for NAD+ Therapeutics
MetroBiotech’s clinical milestone comes amid a surge of interest in NAD+ metabolism as a therapeutic target. With aging populations expanding worldwide and chronic diseases placing increasing burdens on healthcare systems, pharmaceutical companies are ramping up investments in therapies that can intervene earlier in the disease process and enhance longevity.
The NAD+ therapeutics market, while still in its early stages, has seen significant commercial activity, including venture funding, strategic partnerships, and regulatory engagement. MetroBiotech, backed by EdenRoc Sciences, is positioning itself at the forefront of this new frontier, leveraging proprietary chemistry and translational science to accelerate its clinical programs.
As the first patients receive MIB-725 and MetroBiotech moves toward completing its Phase 1a study, the company is focused on rigorous data collection, safety monitoring, and translational biomarker development. The insights gained from this trial will not only shape the dosing strategy for MIB-725 but also inform parallel programs within the company’s broader NAD+ modulator pipeline.
The future of aging medicine may well hinge on addressing the molecular hallmarks of aging, and if successful, MetroBiotech’s NAD+ boosting platform could provide a new class of disease-modifying therapies that promote healthy aging and reduce the burden of chronic disease.
With early human data on the horizon, MIB-725 represents a promising step forward in the development of next-generation therapies for age-related decline—and MetroBiotech appears poised to lead the way.
