The National Institute on Aging, a division of the National Institutes of Health, is awarding a $1.76 million, one-year grant to support a Phase 1 clinical trial investigating oral Jotrol as a potential treatment of early stage Alzheimer’s disease.
The study is to be called “Safety and Pharmacokinetics of JOTROL for Alzheimer’s Disease.” Further information, including an anticipated launch date, was not available in a press release.
Jotrol, made by Jupiter Orphan Therapeutics, is a more biologically active formulation of resveratrol, a naturally occurring anti-inflammatory and antioxidant molecule found in certain foods, including red wine, red grapes, some berries, and peanuts.
A 1997 discovery linked resveratrol, consumed in red wine in that case, to a lower dementia risk. Subsequent studies have identified other potentially neuroprotective effects.
These include reducing markers of brain inflammation and oxidative stress, and preserving the function of mitochondria — the organelles that provide cellular energy and which are often damaged in neurodegenerative diseases such as Alzheimer’s.
Resveratrol was also found to decrease beta-amyloid plaques, those found in the damaged nerve cells of Alzheimer’s patients, in preclinical studies, and to possibly slow age-related cognitive decline.
One drawback to using resveratrol as a medicine is that at orally tolerated doses, little of it actually enters the brain and nervous system. That is, it has poor bioavailability.
Jotrol is designed to overcome this limitation by delivering the compound as an oral softgel in a micellar form. Micelles are water-soluble spheres of fatty molecules easily absorbed into cells, bringing whatever they contain with them.
Resveratrol-laden micelles are expected to cross the blood-brain barrier, delivering resveratrol to nerve cells without the gastrointestinal side effects — such as nausea and diarrhea — associated with high oral doses.
Jupiter reports that a daily dose of Jotrol delivers as much resveratrol as approximately 20 glasses of red wine.
“I am very pleased to receive this award, as it will enable us to take our Jotrol product through Phase I and set us up for Phase II applications,” Marshall Hayward, PhD, Jupiter’s chief scientific officer, said in the release.
“We have a significant advantage in our development programs, guided by scientific publications on resveratrol, internally developed data, and the open-label studies conducted by [Murdoch Children’s Research Institute] in Friedreich’s ataxia patients, and the Turner et.al clinical study in 119 Alzheimer’s patients,” he added.
That study found resveratrol’s use to be safe and well-tolerated by patients, and to alter some of the disease’s “biomarker trajectories.”
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