Jupiter, Florida, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based platform, today announced it has entered into an agreement with Catalent Pharma Solutions, LLC ("Catalent") for the production of JOTROL™ softgel capsules to support Jupiter’s upcoming Phase 2a clinical trial in Parkinson’s disease.
Under the terms of the agreement, Catalent will manufacture clinical batches of JOTROL, Jupiter’s proprietary resveratrol-based therapeutic, using an optimized softgel formulation. The production will include both active and placebo batches for the Parkinson’s study. This manufacturing initiative will be conducted under current Good Manufacturing Practices (CGMP) to meet regulatory and clinical standards.
“Securing an experienced CDMO leader like Catalent is a critical step as we advance JOTROL into clinical development for Parkinson’s disease,” said Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “Catalent’s industry-leading expertise in pharmaceutical manufacturing and its ability to scale production efficiently according to a tight timeline will help us maintain momentum in our development program and support our goal of delivering innovative therapies to patients.”
JOTROL is designed to overcome the historical challenges of resveratrol by significantly enhancing bioavailability while minimizing gastrointestinal side effects. The upcoming Phase 2a trial will evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of JOTROL in Parkinson’s patients over a three-month period.
With over 10 million people affected by Parkinson’s disease worldwide, there remains an urgent need for innovative treatments. The Parkinson’s therapeutics market is projected to exceed $14 billion by 2030. Jupiter Neurosciences continues to pursue strategic partnerships to accelerate JOTROL’s development across multiple indications, including Alzheimer’s and other neurodegenerative diseases.
About Jupiter Neurosciences, Inc.
Jupiter Neurosciences is a clinical-stage pharmaceutical company focused on treating neuroinflammation, with a current focus on CNS disorders and rare diseases. The Company’s platform product, JOTROL™, is an enhanced orally administered resveratrol formulation designed and intended to deliver therapeutically relevant, safe levels of resveratrol. The Company’s pipeline is focused broadly on CNS disorder and includes indications such as Alzheimer’s Disease, Parkinson’s Disease, Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com.
About JOTROL
Resveratrol is one of the world’s most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication.
Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial, and Yui et al., Friedreich’s Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL trials, were published in the Journal of Alzheimer’s Disease and AAPS Open in February 2022.
About Catalent
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.
FORWARD-LOOKING STATEMENTS
Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the use of proceeds from the Offering. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.
Contact:
Dave Gentry RedChip Companies, Inc. 1-407-644-4256 1-800-RED-CHIP (733-2447) JUNS@redchip.com
