Safety, Tolerability, And Efficacy Of NE3107 From A Phase 2, Double-Blind, Placebo-Controlled Study In Levodopa/Carbidopa-Treated Patients With Parkinson's Disease
Clarence Ahlem1, Christopher Reading1, Joseph Djan1, Joseph Palumbo1
1BioVie Inc.
Objective:
To assess the safety, tolerability, and efficacy of NE3107 in levodopa/carbidopa-treated patients with Parkinson’s disease (PD) over 27 days.
Background:
PD is characterized by the loss of dopaminergic neurons and compromised motor control. Levodopa provides pro-motoric relief but lacks disease-modifying potential and can cause motor complications, including levodopa-induced dyskinesia (LID). Inflammatory pathways comprising extracellular signal-regulated kinase (ERK) and nuclear factor-kappa B form a feed-forward loop with oxidative stress to drive neurodegeneration. NE3107 is an oral, blood-brain barrier–permeable molecule that binds ERK and inhibits pro-inflammatory pathways without affecting homeostatic functions. In a marmoset model of PD, NE3107 treatment improved mobility, enhanced levodopa activity, and decreased LID and neuronal death in the substantia nigra.
We initiated a phase 2, double-blind, placebo-controlled study to evaluate the safety, tolerability, efficacy, and pharmacokinetic effects of NE3107 in levodopa/carbidopa-treated patients with PD.
Design/Methods:
Forty patients were planned to be enrolled and randomized 1:1 to receive 20 mg oral NE3107 twice daily or placebo for 27 days. Patients were 30 to 80 years old with a diagnosis of PD, response to levodopa, and bradykinesia. Eligible patients were taking 300 mg levodopa/carbidopa daily and had a history of motor fluctuations with early morning OFF episodes. Safety and tolerability endpoints evaluated treatment-emergent and serious adverse events and suicidality, changes in vital signs, and the percentage of completers. Efficacy endpoints included daily change in The Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III from baseline to post-dose timepoints, MDS-UPDRS Part I and II Scores, and total ON time with or without dyskinesia.
Results:
Outcomes of the efficacy, safety, and tolerability analyses will be presented at the conference.
Conclusions:
Using safety, tolerability, and efficacy analyses, this study aimed to demonstrate the potential therapeutic benefits of NE3107 in levodopa/carbidopa-treated patients with PD.