Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 149

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 149
---
Non-motor symptoms, often
called the “invisible” symptoms, can affect almost every body system and vary in severity. These symptoms can significantly
impact quality of life and include autonomic dysfunctions like constipation, low blood pressure, sexual problems, sweating issues, and
urinary problems. While available therapies can treat some symptoms, there is an urgent need for better treatments to improve quality
of life and slow disease progression. Approved medications for motor symptoms include dopamine replacement therapy (levodopa/carbidopa),
adenosine receptor antagonists, amantadine, anticholinergic medications, COMT inhibitors, decarboxylase inhibitors, dopamine agonists,
and MAO-B inhibitors. Researchers are increasingly recognizing the debilitating nature of non-motor symptoms and are working on new therapies,
while doctors manage these symptoms with current treatments.

Upcoming Phase IIa Study in Parkinson’s Disease Patients

The Company has engaged Zina
Biopharmaceuticals to assist with study design, FDA communications including IND and to manage the execution of the trial. Catalent has
been engaged to manufacture the JOTROL™ clinical trial supplies pursuant to the Manufacturing Agreement between Company
and Catalent dated September 16, 2020, under which Catalent is to provide the Company with clinical batches of JOTROL™ using
a softgel formulation, which will be for active and placebo batches for the Parkinson’s disease study. The preliminary study design
is described below and is subject to final IND approval by the FDA. The Company expects to start the clinical trial in the fourth quarter
of 2025 and have the first study results available within 12 months thereafter.

| 84 |

We are sponsoring a Phase
IIa clinical trial to evaluate the safety, tolerability, and pharmacokinetics of Resveratrol (JOTROL) in individuals
with Parkinson’s Disease. This multicenter, randomized, double-blind, placebo-controlled study involves approximately 30 participants
across three centers in the US. Participants are randomly assigned to one of three groups to receive either a placebo or JOTROL™
at doses of 200mg or 400mg daily for three months. The study aims to explore JOTROL™’s potential to improve energy
metabolism in Parkinson’s Disease. An optional biomarker sub-study will assess cerebrospinal fluid, requiring additional consent.
Each participant will be involved for 4-5 months, with the entire study lasting two years. First readout of results is