Jotrol (trans-resveratrol oral) / Jupiter Neurosci - LARVOL DELTA

Jupiter Neurosciences Announces JOTROL Manufacturing Agreement with Catalent to Support Phase 2a Parkinson’s Trial (GlobeNewswire) - "Jupiter Neurosciences, Inc...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."

Commercial • Parkinson's Disease

Jupiter Neurosciences Partners with Zina Biopharmaceuticals to Advance Phase 2a Parkinson’s Trial (GlobeNewswire) - "Jupiter Neurosciences, Inc...today announced a strategic partnership with Zina Biopharmaceuticals, LLC...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...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."

Commercial • Parkinson's Disease

Jupiter Neurosciences, Inc. Announces Research Breakthrough with JOTROL in Parkinson's Disease (PRNewswire) - “Jupiter Neurosciences, Inc…announced topline proof-of-concept preclinical data with its proprietary resveratrol drug product, JOTROL™, for Parkinson's Disease (PD). In collaboration with scientists Shaun Brothers, PhD, MBA and Candace Carriere, PhD at the University of Miami School of Medicine, the Company recently completed preclinical activities in a validated mouse model of PD. This model of PD mimics many aspects of the disease utilizing a unilateral injection of a neurotoxin precursor that elicits nigral cell loss, striatal dopamine loss and behavior deficits similar to physiological characteristics of human Parkinson's disease.”

Preclinical • CNS Disorders • Parkinson's Disease

Jupiter Neurosciences, Inc. Announces Research Breakthrough with JOTROL in Parkinson's Disease (PRNewswire) - "Jupiter Neurosciences, Inc...announced topline proof-of-concept preclinical data with its proprietary resveratrol drug product, JOTROL™, for Parkinson's Disease (PD)....This model of PD mimics many aspects of the disease utilizing a unilateral injection of a neurotoxin precursor that elicits nigral cell loss, striatal dopamine loss and behavior deficits similar to physiological characteristics of human Parkinson's disease. Statistically significant positive outcomes, particularly in the endpoint of enhanced grip strength, has now been established in two preclinical indications, PD and MPSI....Additional findings include JOTROL™ significantly improving an outcome used to evaluate motor coordination, rotarod performance; significantly improving behavioral characteristics induced in the animal model; as well as being generally safe and well tolerated."

Preclinical • CNS Disorders • Parkinson's Disease

JOTROL PK, Safety, and Food Effect Assessment (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jupiter Orphan Therapeutics Inc. | Recruiting ➔ Completed

Trial completion

Safety and pharmacokinetics of a highly bioavailable resveratrol preparation (JOTROL ). (PubMed, AAPS Open) - P1 | "Studies in Alzheimer's patients and in MPS 1 are currently in development to test the effect this improved bioavailability has on those patient populations (Clintrials.gov, NCT04668274, 12/16/2020, https://clinicaltrials.gov/ct2/show/NCT04668274). The online version contains supplementary material available at 10.1186/s41120-022-00058-1."

Journal • PK/PD data • Alzheimer's Disease • Ataxia • CNS Disorders • Cognitive Disorders • Dementia • Friedreich ataxia • Hurler Syndrome • Immunology • Inflammation • Movement Disorders • Oncology

Jupiter Neurosciences, Inc. Announces Journal of Alzheimer's Disease Publication Highlighting use of JOTROL (PRNewswire) - "Jupiter Neurosciences, Inc...announced the publication in the Journal of Alzheimer's Disease of 'JOTROL™, a Novel Formulation of Resveratrol, Shows Beneficial Effects in the 3xTg-AD Mouse Model'....The results showed that JOTROL™ significantly increased bioavailability over non-formulated resveratrol and that treatment resulted in AD-related gene expression changes, as well as changes in inflammatory gene and cytokine levels. JOTROL™ may be effective as a prophylaxis and/or treatment for AD through increased expression and/or activation of neuroprotective genes, suppression of pro-inflammatory genes, and regulation of central and peripheral cytokine levels."

Preclinical • Alzheimer's Disease • CNS Disorders

"JOTROL, a Novel Formulation of Resveratrol, Shows Beneficial Effects in the 3xTg-AD Mouse Model https://t.co/XwO1ZHH6KT" (@ArcticDefenders)

Preclinical

Jupiter Neurosciences, Inc. Announces Completion of Phase I Safety Trial with Enhanced Resveratrol Product, JOTROL (PRNewswire) - “Jupiter Neurosciences, Inc…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.”

Trial completion • Alzheimer's Disease • CNS Disorders

JOTROL, a Novel Formulation of Resveratrol, Shows Beneficial Effects in the 3xTg-AD Mouse Model. (PubMed, J Alzheimers Dis) - "JOTROL may be effective as a prophylaxis and/or treatment for AD through increased expression and/or activation of neuroprotective genes, suppression of pro-inflammatory genes, and regulation of central and peripheral cytokine levels."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Immunology • Inflammation • BDNF

Jupiter Orphan Therapeutics, Inc. Announces New Corporate Name, Jupiter Neurosciences, Inc. (PRNewswire) - "Jupiter Orphan Therapeutics, Inc...today announced a name change to Jupiter Neurosciences, Inc., and a new website, www.jupiterneurosciences.com. The name and branding were chosen to reflect the Company's expanded focus to include CNS disorders, such as Alzheimer's disease, traumatic brain injury (TBI), and concussion....'While orphan diseases like MPS-I and Friedreich's ataxia remain the cornerstone of our pipeline, recent scientific data indicate strong anti-inflammatory effects with our product, JOTROL™.'"

Commercial • Alzheimer's Disease • CNS Disorders

[VIRTUAL] Jupiter Orphan Therapeutics (BIO 2021) - "JOTs unique resveratrol formulation, JOTROLTM, is the first product in the world to allow delivery of safe, therapeutic doses of resveratrol...Less risk, more opportunities and faster to market. Jupiter Orphan Therapeutics is presenting as part of the NIH Innovation Zone."

Alzheimer's Disease • CNS Disorders • Rare Diseases

JOTROL PK, Safety, and Food Effect Assessment (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Marshall A. Hayward, Ph.D.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Jupiter Orphan Therapeutics Announces First Patient Dosed in Phase I Dose Escalation Study of JOTROL (PRNewswire) - "Jupiter Orphan Therapeutics, Inc...today announced that the first patient has been dosed in a Phase I dose escalation study of JOTROL™....Per protocol, the first patient cohort has been dosed and the study is continuing in January and February of 2021. Top line data is expected to be available in March 2021. The initial dose appear well-tolerated...We are assuming positive Phase I results, which will be a Proof Of Concept of our product and have started preparations for Phase II trials in in MPS-1, Friedreich's ataxia and MELAS in addition to MCI study preparation. 'We have presently cash covering us through 2021 and are targeting additional financing through an equity raise, possible partnering as well as utilizing non-dilutive funding sources to be able to start several Phase II trials later in 2021'...'With financing in place, we may have positive clinical results already by mid 2022'..."

Financing • New P2 trial • P1 data • P2 data • Trial status • Alzheimer's Disease • CNS Disorders • Friedreich ataxia

JOTROL PK, Safety, and Food Effect Assessment (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Marshall A. Hayward, Ph.D.

Clinical • New P1 trial

Jupiter Orphan Announces Federal Grant to ADVANCE JOTROL to Phase I Clinical Trial for Alzheimer’s (PRNewswire) - "Jupiter Orphan Therapeutics, Inc....announced today that the National Institute on Aging at the NIH will award it $1.76 million (over 1 year) to support a Phase I clinical study of JOTROL™, for the treatment of early-stage Alzheimer's disease....'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'....Jupiter Orphan Therapeutics' long-term focus is to develop a treatment for Alzheimer's Disease, while in parallel, developing one or more treatments for rare, 'orphan' diseases including Friedreich's ataxia and Mucopolysaccharidosis Type-I..."

Grant • New P1 trial • Alzheimer's Disease • CNS Disorders

[VIRTUAL] Benefits of a novel highly bioavailable resveratrol formulation, JOTROL, for Alzheimers disease (AAIC 2020) - "JOTROL has a strong anti-inflammatory effect in the brain and peripheral organs, promotes non-amyloidogenic processing of the amyloid precursor protein and increases mitochondrial biogenesis. Further investigation is underway to determine prophylactic effects of JOTROL for AD pathogenesis."

Alzheimer's Disease • CNS Disorders • APP • IL6