The company Metro International Biotech, which has David Sinclair on its scientific advisory board, has unveiled that its NAD+-boosting drug MIB-725 has begun undergoing human trials.
Highlights
Metro International Biotech (MetroBiotech) seeks to advance more effective treatments for age-related diseases, addressing this goal with nicotinamide adenine dinucleotide (NAD+)-elevating drugs. As such, they announced that their NAD+-elevating drug, MIB-725, has entered human trials. In that regard, the first group of patients in an MIB-725 human trial has received its initial doses of the drug.
MIB-725 is a new, proprietary drug from MetroBiotech, now undergoing initial human trials (in Phase Ia trials) studying its safety, metabolism, and effects on circulating NAD+. Interestingly, preclinical rodent studies demonstrated that MIB-725 is a potent NAD+ booster. If the Phase Ia human trials with MIB-725 prove successful, later trials will test MIB-725’s efficacy in treating age-related chronic kidney disease.
According to a press release, toxicity was not observed in the first four of eight patients dosed with MIB-725. Once the remaining four participants receive their dose of MIB-725, the researchers will subsequently increase doses to test whether higher doses are safe. If this initial trial with single doses concludes successfully, a follow-up trial with multiple doses (Phase Ib trials) will also commence at the same investigational site.
“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, in the press release. “The current single ascending dose trial of MIB-725 will create our first safety, [pharmacokinetics/pharmacodynamics] and metabolic database for this unique molecule, and is an important milestone in our company’s clinical development program. 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.”
MIB-725 is the second drug that MetroBiotech has developed that targets age-related diseases, such as kidney disease, neurodegenerative disease, and muscle dysfunction. Along those lines, MetroBiotech is currently running a human trial testing the effectiveness of another of its NAD+-boosting drugs, MIB-626, at improving levels of circulating factors associated with aging in patients with Alzheimer’s. Moreover, both MIB-626 and MIB-725 have been shown to increase circulating NAD+ and suppress pancreas inflammation and kidney injury in preclinical models. While the differences in how these two drugs raise NAD+ remain unclear, the press release from BusinessWire claims they target NAD+-elevating pathways in different ways.
MetroBiotech aims to develop NAD+-elevating drugs to treat age-related conditions, such as muscle weakness, kidney diseases, neurodegenerative diseases, and cancer. In doing so, MetroBiotech has designed drugs like MIB-626 and MIB-725 that effectively increase circulating NAD+. Accordingly, both MIB-626 and MIB-725 have received FDA designations as investigational new drugs, which allow their testing in humans.
Human trials have already shown that NAD+ precursors like nicotinamide mononucleotide (NMN) and nicotinamide riboside (NR) effectively increase circulating NAD+. This begs the question of what potential advancements MetroBiotech has made with their NAD+-elevating drug MIB-725 that effectively increases circulating NAD+ and possibly treats age-related diseases.
The tantalizing advancement of human trials using MIB-725 will reveal whether effectively increasing circulating NAD+ levels treats age-related diseases. Aside from increasing circulating NAD+, human trials using NAD+ precursors on their own have yielded mixed results related to aging-related parameters. Hence, if MetroBiotech’s new, proprietary drugs that increase circulating NAD+ in a way similar to NAD+ precursors confer more consistent effects against conditions related to aging, such breakthrough findings could pave the way for more NAD+ pathway-related drugs.