Metro International Biotech (MetroBiotech) has begun dosing patients in a Phase 1a clinical trial of MIB-725, a novel NAD booster designed to treat age-related diseases. The Worcester, Massachusetts-based company announced that the first four patients in the initial cohort have received their doses with no dose-limiting toxicities observed.
MIB-725 represents the company's second therapeutic candidate targeting diseases of aging, with a particular focus on chronic kidney disease. The investigational drug has demonstrated potent NAD-boosting effects in preclinical studies.
"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 David Livingston, Ph.D., president and chief scientific officer of MetroBiotech.
Trial Design and Initial Results
The Phase 1a trial employs a single ascending dose design to evaluate safety, pharmacokinetics, metabolism, and the effect of MIB-725 on circulating NAD levels. The initial cohort will include eight patients total, with four having already received their doses.
Following completion of the first cohort, subsequent doses will be gradually increased according to the trial protocol. If this single-dose study concludes successfully, MetroBiotech plans to advance to a Phase 1b multiple-dosing trial at the same clinical site.
Livingston emphasized the significance of this milestone: "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."
Therapeutic Potential and Mechanism
MIB-725 functions as an NAD precursor or "booster," designed to increase levels of nicotinamide adenine dinucleotide (NAD), a coenzyme essential for cellular metabolism and energy production that typically declines with age.
Preclinical studies have demonstrated MIB-725's pharmacological activity across multiple disease models, showing NAD-boosting effects and suppression of conditions including pancreatitis, acute kidney injury, and cardiovascular dysfunction associated with rare mitochondrial diseases.
While the current Phase 1a trial focuses primarily on safety and pharmacokinetics, future clinical studies will investigate MIB-725's efficacy specifically in treating chronic kidney disease associated with aging.
Expanding Pipeline for Age-Related Diseases
MIB-725 joins MetroBiotech's growing portfolio of NAD-boosting compounds. The company's lead candidate, MIB-626, is currently advancing through Phase 2 clinical trials. Both compounds have shown promise in preclinical models but operate through different NAD-elevating pathways in mammals.
MetroBiotech, an EdenRoc Sciences company, distinguishes itself in the NAD booster space through its commitment to FDA standards for investigational drugs. The company's clinical programs for both MIB-725 and MIB-626 are being conducted under INDs cleared by the FDA.
The company's broader mission focuses on developing treatments for various age-related conditions, including muscle weakness, kidney diseases, neurodegenerative diseases, and cancer, using NAD boosters designed for high safety profiles and organ-specific targeting.
Future Directions
Livingston expressed optimism about the potential insights from this initial trial: "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."
If successful, MIB-725 could represent an important addition to the therapeutic arsenal against age-related diseases, particularly chronic kidney disease, which affects millions of older adults worldwide and has limited treatment options.
The remaining four patients in the first cohort are expected to receive their doses soon, with results from this Phase 1a trial potentially setting the stage for more advanced clinical studies of this novel NAD-boosting compound.
