Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 154

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 154
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of interested and eligible ADCS sites - with experienced study coordinators, raters, and site PIs.

Description of Study Intervention:
Subjects will be randomized 1:1:1 to receive 500 mg bid (1g/day) resveratrol as JOTROL™; or 200 mg bid (400mg/day) resveratrol
as JOTROL™; or placebo.

Participant Duration:
Treatment phase will be 6 months with a one month follow up safety visit and safety monitoring over a 6-month period to ensure that patients
have no long-lasting treatment related effects.

Rare Orphan Diseases

JNS101 Friedreich’s ataxia direct to Phase II

JNS101 is a project utilizing
JOTROL™, specifically designed to treat Friedreich’s ataxia.

Friedreich’s ataxia
(“FA”) is a rare inherited disease that causes damage to the nervous system as well as mobility dysfunctions. FA usually begins
in childhood and leads to impaired muscle coordination (ataxia) which worsens over time. It is caused by a defect (mutation) in a gene
labeled FXN. Friedreich’s ataxia is recessive, meaning it only occurs in someone who inherits two defective copies of the gene,
one from each parent. Although rare, FA is the most common form of hereditary ataxia, affecting about 1 in 50,000 people in the United
States. EU5 (5 largest European countries) alone has approximately the same amount of FA patients as there are in USA.

In 2014 Murdoch Children’s
Research Institute (“MCRI”) conducted a clinical trial in 27 human subjects where 24 completed the study, resulting in that
a high daily dose (5 grams) of nutritional grade trans-resveratrol had statistically different positive results, see p-values for 5 g
daily dosing in the table below, on established Friedreich’s ataxia measurements. Key markers, such as FARS Score and measurements
of hearing and speech parameters were included in these positive results. The results indicate that an effective dose of resveratrol is
expected to be a meaningful treatment for patients with Friedreich’s ataxia. The data from the MCRI study was used in pre-IND meetings
with the FDA discussing our Phase II study and was also referenced in our application for orphan drug designation (ODD). The ODD, request
#17-5978, was granted to us by the