Jupiter Neurosciences Announces JOTROL Manufacturing Agreement with Catalent to Support Phase 2a Parkinson’s Trial
Jupiter Neurosciences (NASDAQ: JUNS) has announced a manufacturing agreement with Catalent Pharma Solutions for the production of JOTROL™ softgel capsules to support its upcoming Phase 2a clinical trial in Parkinson's disease. The agreement covers the manufacture of both active and placebo batches under CGMP standards.
JOTROL, Jupiter's proprietary resveratrol-based therapeutic, is designed to enhance bioavailability while reducing gastrointestinal side effects. The Phase 2a trial will evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of JOTROL in Parkinson's patients over three months.
The company notes that Parkinson's disease affects over 10 million people globally, with its therapeutics market projected to exceed $14 billion by 2030. Jupiter is also pursuing strategic partnerships to develop JOTROL for other indications, including Alzheimer's and other neurodegenerative diseases.
Jupiter Neurosciences (NASDAQ: JUNS) ha annunciato un accordo di produzione con Catalent Pharma Solutions per la produzione delle capsule softgel JOTROL™ a supporto del prossimo trial clinico di Fase 2a sulla malattia di Parkinson. L'accordo copre la produzione sia di lotti attivi che di placebo nel rispetto degli standard CGMP.
JOTROL, il farmaco proprietario di Jupiter a base di resveratrolo, è progettato per migliorare la biodisponibilità riducendo al contempo gli effetti collaterali gastrointestinali. Il trial di Fase 2a valuterà la sicurezza, la tollerabilità e la farmacocinetica/farmacodinamica di JOTROL nei pazienti affetti da Parkinson per un periodo di tre mesi.
La società nota che la malattia di Parkinson colpisce oltre 10 milioni di persone a livello globale, con un mercato dei farmaci terapeutici previsto per superare i 14 miliardi di dollari entro il 2030. Jupiter sta anche cercando partenariati strategici per sviluppare JOTROL per altre indicazioni, inclusa l'Alzheimer e altre malattie neurodegenerative.
Jupiter Neurosciences (NASDAQ: JUNS) ha anunciado un acuerdo de fabricación con Catalent Pharma Solutions para la producción de cápsulas softgel JOTROL™ para apoyar su próximo ensayo clínico de Fase 2a en la enfermedad de Parkinson. El acuerdo cubre la fabricación de lotes activos y de placebo bajo los estándares CGMP.
JOTROL, el tratamiento exclusivo de Jupiter a base de resveratrol, está diseñado para mejorar la biodisponibilidad mientras reduce los efectos secundarios gastrointestinales. El ensayo de Fase 2a evaluará la seguridad, la tolerabilidad y la farmacocinética/farmacodinámica de JOTROL en pacientes con Parkinson durante tres meses.
La empresa señala que la enfermedad de Parkinson afecta a más de 10 millones de personas en todo el mundo, y se prevé que el mercado de terapias supere los 14 mil millones de dólares para 2030. Jupiter también está buscando asociaciones estratégicas para desarrollar JOTROL para otras indicaciones, incluidas el Alzheimer y otras enfermedades neurodegenerativas.
주피터 뉴로사이언스(Jupiter Neurosciences, NASDAQ: JUNS)가 카탈렌트 제약 솔루션(Catalent Pharma Solutions)과 파킨슨병에 대한 2a상 임상 시험을 지원하기 위해 JOTROL™ 소프트젤 캡슐 생산을 위한 제조 계약을 발표했습니다. 이 계약은 CGMP 기준에 따라 활성 및 플라시보 배치의 제조를 포함합니다.
JOTROL은 주피터의 독점적인 레스베라트롤 기반 치료제로, 생체이용률을 향상시키면서 위장 부작용을 줄이도록 설계되었습니다. 2a상 시험은 3개월 동안 파킨슨병 환자에서 JOTROL의 안전성, 내약성 및 약리학적 동태/역동성을 평가합니다.
회사는 파킨슨병이 전 세계적으로 1천만 명 이상의 사람들에게 영향을 미친다고 언급하며, 치료제 시장이 2030년까지 1천4백억 달러를 초과할 것으로 예상됩니다. 주피터는 또한 알츠하이머 및 기타 신경퇴행성 질환을 포함한 다른 적응증에 대해 JOTROL을 개발하기 위한 전략적 파트너십을 추진하고 있습니다.
Jupiter Neurosciences (NASDAQ: JUNS) a annoncé un accord de fabrication avec Catalent Pharma Solutions pour la production de capsules molles JOTROL™ afin de soutenir son prochain essai clinique de Phase 2a sur la maladie de Parkinson. L'accord couvre la fabrication à la fois de lots actifs et de placebo selon les normes CGMP.
JOTROL, le traitement exclusif de Jupiter basé sur le resvératrol, est conçu pour améliorer la biodisponibilité tout en réduisant les effets secondaires gastro-intestinaux. L'essai de Phase 2a évaluera la sécurité, la tolérance et la pharmacocinétique/pharmacodynamique de JOTROL chez des patients parkinsoniens pendant trois mois.
L'entreprise note que la maladie de Parkinson touche plus de 10 millions de personnes dans le monde, avec un marché thérapeutique prévu pour dépasser 14 milliards de dollars d'ici 2030. Jupiter poursuit également des partenariats stratégiques pour développer JOTROL pour d'autres indications, y compris Alzheimer et d'autres maladies neurodégénératives.
Jupiter Neurosciences (NASDAQ: JUNS) hat eine Herstellungsvereinbarung mit Catalent Pharma Solutions bekannt gegeben, um JOTROL™ Softgelkapseln für die bevorstehende Phase 2a-Studie zur Parkinson-Krankheit herzustellen. Die Vereinbarung umfasst die Herstellung von aktiven und Placebo-Batches gemäß den CGMP-Standards.
JOTROL, das firmeneigene therapeutische Mittel von Jupiter auf Resveratrolbasis, soll die Bioverfügbarkeit erhöhen und gleichzeitig gastrointestinale Nebenwirkungen reduzieren. Die Phase 2a-Studie wird die Sicherheit, Verträglichkeit sowie Pharmakokinetik/-dynamik von JOTROL bei Parkinson-Patienten über einen Zeitraum von drei Monaten bewerten.
Das Unternehmen weist darauf hin, dass die Parkinson-Krankheit weltweit über 10 Millionen Menschen betrifft und der Markt für therapeutische Mittel bis 2030 voraussichtlich 14 Milliarden Dollar übersteigen wird. Jupiter sucht auch strategische Partnerschaften zur Entwicklung von JOTROL für andere Indikationen, einschließlich Alzheimer und anderen neurodegenerativen Erkrankungen.
- Secured manufacturing agreement with major CDMO Catalent for Phase 2a trial production
- Targeting Parkinson's market projected to reach $14B by 2030
- JOTROL addresses historical resveratrol challenges with enhanced bioavailability
- None.
Insights
The manufacturing agreement with Catalent marks a pivotal operational advancement for Jupiter Neurosciences, carrying several strategic implications for investors. Catalent, as one of the world's largest CDMOs with over 50 global facilities, brings industrial-scale manufacturing capabilities that could support JOTROL's commercialization beyond just clinical trials. This partnership significantly de-risks the manufacturing aspect of Jupiter's development program.
The selection of softgel capsule technology is particularly noteworthy, as it typically offers enhanced stability and consistent drug delivery - important factors for JOTROL's unique resveratrol formulation. The agreement's timing suggests Jupiter is maintaining its development timeline, though investors should note that Phase 2a results will be a key catalyst for value creation.
The market opportunity is compelling:
- The
$14 billion projected Parkinson's market by 2030 represents significant revenue potential - JOTROL's potential expansion into Alzheimer's and other neurodegenerative diseases could multiply the addressable market
- The enhanced bioavailability claim, if validated in clinical trials, could provide a significant competitive advantage over existing resveratrol-based treatments
However, investors should consider that while this manufacturing agreement is positive, several critical milestones remain, including:
- Successful completion of the Phase 2a trial
- Demonstration of JOTROL's enhanced bioavailability in humans
- Potential strategic partnerships for later-stage development
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
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
FAQ
What is the purpose of Jupiter Neurosciences' Phase 2a trial for JOTROL in Parkinson's disease?
When will Jupiter Neurosciences (JUNS) begin manufacturing JOTROL for the Parkinson's trial?
What makes JOTROL different from traditional resveratrol treatments?
What other indications is Jupiter Neurosciences (JUNS) pursuing for JOTROL besides Parkinson's?
How large is the market opportunity for JUNS's JOTROL in Parkinson's disease?
