Jupiter Neurosciences partners with Zina Biopharmaceuticals for Phase 2a clinical trial of JOTROL™ for Parkinson’s disease.
Quiver AI Summary
Jupiter Neurosciences, Inc. has announced a strategic partnership with Zina Biopharmaceuticals to support its upcoming Phase 2a clinical trial for JOTROL™, a patented resveratrol-based therapy intended for Parkinson’s disease. Zina will assist with various aspects of the trial, including protocol design, regulatory strategy, and site selection, aimed at evaluating JOTROL's safety, tolerability, and pharmacokinetics in patients. JOTROL is designed to enhance the bioavailability of resveratrol while reducing gastrointestinal side effects, and previous preclinical studies suggest it may help address neurodegeneration. With over 10 million people affected by Parkinson’s globally, there is a pressing need for new treatments, and Jupiter aims to leverage JOTROL for this and potentially other CNS disorders.
Potential Positives
- Jupiter Neurosciences has formed a strategic partnership with Zina Biopharmaceuticals to support the upcoming Phase 2a clinical trial for JOTROL™, enhancing its capabilities in trial execution.
- The Phase 2a trial aims to evaluate the safety and tolerability of JOTROL in patients with Parkinson's disease, addressing a significant unmet medical need in a market projected to exceed $14 billion by 2030.
- JOTROL's innovative micellar formulation has demonstrated over nine times higher bioavailability compared to prior resveratrol products, potentially improving treatment outcomes for neurodegenerative disorders.
- The partnership with Zina will facilitate efficient clinical trial protocol design and regulatory strategy, positioning Jupiter for future pivotal studies and market entry.
Potential Negatives
- Jupiter Neurosciences' reliance on a strategic partnership with Zina Biopharmaceuticals for trial execution may indicate a lack of sufficient internal resources or expertise to conduct the Phase 2a trial independently.
- The press release highlights the historical limitations and challenges associated with resveratrol, suggesting that regulatory hurdles and gastrointestinal side effects might still pose significant risks for JOTROL’s approval and market acceptance.
- Forward-looking statements caution investors about potential risks and uncertainties, indicating that the company's projected outcomes may not materialize as expected.
FAQ
What is JOTROL and its significance?
JOTROL is a patented resveratrol-based therapeutic platform developed by Jupiter Neurosciences, aimed at treating Parkinson’s disease and other CNS disorders.
What clinical trial is Jupiter Neurosciences planning?
Jupiter is preparing for a Phase 2a clinical trial to evaluate the safety and tolerability of JOTROL in Parkinson's patients.
Who is partnering with Jupiter for the clinical trial?
Zina Biopharmaceuticals has partnered with Jupiter to provide comprehensive services for the execution of the Phase 2a clinical trial.
What are the expected outcomes of the Phase 2a trial?
The trial aims to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of JOTROL in patients with Parkinson's disease.
Why is JOTROL's formulation advantageous?
JOTROL's micellar formulation enhances resveratrol's bioavailability while minimizing gastrointestinal side effects, addressing historical limitations of the compound.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
Jupiter, Florida, Jan. 30, 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 a strategic partnership with Zina Biopharmaceuticals, LLC ("Zina") to support all aspects of Jupiter’s upcoming Phase 2a clinical trial for Parkinson’s disease.
Under the terms of the agreement, Zina will provide comprehensive services related to the execution of the exploratory Phase 2a trial evaluating JOTROL ™ , Jupiter’s patented resveratrol-based therapeutic platform. The primary objective of the trial will be to evaluate the safety and tolerability of JOTROL in patients with Parkinson’s, with secondary and exploratory endpoints to assess pharmacokinetics/pharmacodynamics (PK/PD) of the drug.
JOTROL’s innovative micellar formulation overcomes the historical limitations of resveratrol by achieving significantly enhanced bioavailability while minimizing gastrointestinal side effects. Preclinical studies have demonstrated JOTROL’s potential in mitigating key biomarkers associated with neurodegeneration, supporting its potential application in Parkinson’s disease and other central nervous system (CNS) disorders.
“This partnership with Zina marks a significant milestone for Jupiter as we advance JOTROL into Phase 2 clinical development for Parkinson’s,” said Christer Rosén, Chairman and CEO of Jupiter Neurosciences. “Zina’s extensive expertise in trial execution, as well as regulatory, clinical and scientific strategy, will be instrumental in accelerating our development timeline and positioning us for future pivotal studies.”
Under the agreement, Zina will assist with clinical trial protocol design, including pharmacokinetics and biomarkers, regulatory strategy, and trial site selection to facilitate a smooth trial execution and future clinical progression.
Parkinson’s disease affects over 10 million people worldwide, with no disease-modifying treatments currently available. The global Parkinson’s therapeutics market is projected to exceed $14 billion by 2030, highlighting the urgent need for novel interventions. Jupiter Neurosciences remains committed to leveraging JOTROL’s unique pharmacological advantages to address this significant unmet medical need.
Jupiter is actively exploring additional strategic partnerships to expand JOTROL’s application across other neuroinflammatory and metabolic disorders, including Alzheimer’s disease and longevity medicine.
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 Zina Biopharmaceuticals, LLC
Zina Biopharmaceuticals is a specialized consulting company providing end-to-end trial design and execution solutions as well as regulatory, scientific and medical advice for biotech and pharmaceutical companies.
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.
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