Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 152

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 152
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igator of our proposed Phase II trial. The study tried 500mg, 1000mg, 1500mg and 2000mg daily doses with each dose taken by the
patients over 13 weeks. Only the highest dose of 2000mg (2 X 1g per day) showed positive results on biomarkers which lead to the conclusion
that this study was most likely underdosed for achieving the best therapeutic effect. PK analysis showed that the average C-Max of resveratrol
in the blood on the highest dose was 181 ng/ml, which is far from the target of 300ng/ml that we believe is needed for reaching therapeutic
effect.

Our team of scientists in
the Alzheimer’s field, Professors Raymond Turner, MD, Ph.D. and Charbel Moussa, Ph.D. from Georgetown University, Rudolph Tanzi,
Ph.D. from Harvard and Li-Huei Tsai, Ph.D. from MIT are assisting in designing our Phase II study to address and explore biomarkers and
areas where the trial results can guide us to a follow-on Phase IIb/Phase III trial, if approved to do so by the FDA, that might generate
meaningful outcomes for MCI/early Alzheimer’s disease patients. The Company has not discussed its ability to rely on and reference
the Phase II trial conducted by Georgetown with the FDA nor has it discussed the design of the planned Phase II study in MCI patients
with the FDA.

Proposed JOTROL™ MCI Phase II Study

The Company prepared a draft
synopsis of an MCI Phase II study. The Company did not receive a grant for this study and it will modify it after the results of the Phase
2a Parkinson’s Disease study are conducted.

STUDY SYNOPSIS Title:
A phase II, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JOTROL™ (micellar resveratrol
solubilisation formulation) in early Alzheimer’s disease (“AD”) patients study description: This study seeks to assess
the safety and efficacy of JOTROL™ (resveratrol) in patients with MCI/early AD. Approximately 105 patients will be enrolled
at study centers across the United States. Patients will be randomized into one of two active treatment arms to receive JOTROL™
200 mg BID or JOTROL™ 500 mg BID or to a placebo group. We hypothesize that JOTROL™ will