Clinical Trials in Neurology
For Physicians & Researchers
Semaphorin 4D (SEMA4D) has been found to contribute to driving the neuroinflammation implicated in progression of these disorders, suggesting that blocking SEMA4D has promising potential as a new therapy for neurodegenerative diseases.
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Vaccinex is studying pepinemab in clinical trials of patients with Alzheimer’s & Huntington's disease, and is exploring the potential to treat other neurological disorders.
Note:Â Pepinemab (VX15/2503) is an investigational drug currently in clinical studies. It has not been demonstrated to be safe and effective for any disease indication. There is no guarantee that pepinemab (VX15/2503) will be approved for the treatment of any disease by the U.S. Food and Drug Administration or by any other health authority worldwide.
Neurology Trials
Vaccinex’s approach is to potentially reprogram the underlying disease pathology that is driven by neuroinflammation with concomitant loss of normal important support functions of glial cells, such as astrocytes and microglia.
About the Trial
SIGNAL-AD was a randomized double-blind, placebo-controlled, parallel-group study of pepinemab in early AD dementia defined as MCI and mild Alzheimer’s dementia. The study was 48 weeks in duration.
Key Eligibility Criteria
   MMSE 17-26
   CDR-GS 0.5-1
   Confirmed Amyloid positivity
Clinical Trial Evaluating the Safety and Efficacy of Pepinemab in Patients with Alzheimer’s Disease
In collaboration with the Alzheimer's Association and the Alzheimer's Drug Discovery Foundation
Secondary Outcome Measures
Clinical Dementia Rating (CDR-SB)
Alzheimer's Disease Assessment Scale (ADAS-Cog13)
AD Cooperative Study Activities of Daily Living (ADCS-ADL)
Mini Mental State Examination (MMSE)
Biomarkers of brain metabolism (FDG-PET)
Fluid biomarker assessments
Primary Outcome
Measures
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Safety & Tolerability:
Treatment EmergentÂ
Adverse Events (TEAE)
A Study in Subjects with Late Prodromal and Early Manifest Huntington’s Disease to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Pepinemab
The purpose of this Phase 2 study was to evaluate the safety, tolerability, PK, and efficacy with respect to HD cognitive assessments and Clinical Global Impression of Change of pepinemab (VX15/2503) in participants with late prodromal and early manifest Huntington’s disease. A comprehensive analysis of results was published in Nature Medicine in 2022.
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There are currently no approved disease modifying treatments that impact disease progression in HD.
About the Trial
The SIGNAL trial was a Phase 2 study comparing pepinemab or placebo in Huntington's Disease patients. Throughout the study, participants were assessed for clinical features of Huntington’s disease, as well as brain imaging and PK/PD assessments.Â