JUPITER, Fla. and BOSTON, Feb. 23, 2022 /PRNewswire/ -- Jupiter Neurosciences, Inc. ("Jupiter" or the "Company"), today announced the completion of its Phase I clinical trial with its proprietary JOTROL™, an enhanced formulation of resveratrol with increased bioavailability. Jupiter is a clinical-stage drug platform company focused on making a significant impact for patients and society through a safe and oral medication intended to treat Alzheimer's disease and a broad spectrum of rare diseases. In this first-in-man trial, JOTROL™ was administered in ascending doses in normal healthy volunteers to assess safety, tolerability, and pharmacokinetics. JOTROL™ was determined to be safe and well tolerated at all dose levels administered, with the data safety monitoring board (DSMB) reporting no serious adverse events (SAEs). Additionally, JOTROLTM demonstrated blood plasma levels 8-10-fold higher than naïve resveratrol administered in historical clinical trials, meeting performance objectives. The study was financed by a grant from the National Institute on Aging (NIA), entitled Safety and Pharmacokinetics of JOTROL for Alzheimer's Disease.
"These data are exciting to report as we continue the advancement of our proprietary JOTROL™," stated Marshall Hayward, Ph.D., co-founder and CSO of Jupiter Neurosciences. "We believe that resveratrol has strong therapeutic potential but also shows poor bioavailability, which is treatment limiting. Optimizing the natural therapeutic power of resveratrol has been a focus of study for decades, and our ability to improve the formulation to produce such efficient adsorption is a breakthrough for the Company."
"We now look forward to advancing our platform drug product into the clinic in several patient populations as we advance our development efforts," stated Alison Silva, President and CBO. "We believe that these encouraging data also enable us to initiate our evaluation of strategic partnership opportunities outside the indications and regions we have internally prioritized."
Jupiter Neurosciences has developed a unique and patented platform product, JOTROL™, an enhanced resveratrol formulation. JOTROL™, based on our pre-clinical and Phase I study results, delivers resveratrol into the blood plasma with significantly greater bioavailability, without generating any adverse events, than conventional resveratrol. Resveratrol has the ability to cross the blood-brain barrier, where it has, in studies conducted in Friedreich's ataxia (FA) and Alzheimer's disease (AD) patients, positive effects on oxidative stress, inflammation and mitochondrial function. JOTROL™ has many potential indications of use in rare diseases, of which we are primarily targeting Mucopolysaccharidoses Type 1, Friedreich's ataxia, MELAS and early-stage ALS. In the broader disease indication areas, JOTROL™ will target mild cognitive impairment/early Alzheimer's disease. TBI/concussion and Covid-19 are future projects in early-stage development.
About Jupiter Neurosciences, Inc.
Jupiter Neurosciences, Inc. is a clinical-stage pharmaceutical company focused on treating CNS disorders and rare diseases. The Company's platform product, JOTROL™, offers potential therapeutic benefit to most central nervous system diseases such as Alzheimer's disease, ataxias, and metabolic disorders such as Lysosomal Storage Disorders and mitochondrial diseases. Human clinical trial data shows benefits in several indications and the FDA has accepted a first investigational new drug (IND) application of JOTROL™. More information may be found on the Company's website www.jupiterneurosciences.com.
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; the size of the potential markets for the Company's drug candidates and its ability to service those markets; and the Company's current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
SOURCE Jupiter Neurosciences, Inc.