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news.US-based clinical-stage immunotherapy firm Vaccinex has started a Phase II clinical trial (SIGNAL) of anti-semaphorin 4D antibody VX15/2503 (VX15) for the treatment of patients with Huntington's disease (HD).
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Around 84 subjects with late-prodromal or early-manifest HD will be included in the Phase III SIGNAL trial.
The trial will be performed with the assistance of the Huntington Study Group and is designed to evaluate the safety, tolerability and efficacy of VX15 antibody in these patients.
HD is a neurodegenerative genetic disorder that typically manifests in mid-adult life.
The trial is based on the company’s prior research of neurodegenerative disease mechanisms, where it showed in preclinical models that semaphorin 4D (SEMA4D) triggers activation of both microglia and astrocytes, the innate inflammatory cells of the central nervous system.
The chronic activation of microglia and astrocytes has been implicated as a potentially important disease mechanism in HD, progressive multiple sclerosis (MS) as well as other neurodegenerative disorders.
The company said that VX15 antibody is designed to block the functional activity of SEMA4D.
Vaccinex president and chief executive officer Dr Maurice Zauderer said: "We are very pleased to have initiated this clinical trial of our novel agent in a disease with such an important unmet need.
"The preclinical data generated with our antibody in an animal model of Huntington’s disease and our understanding of the mechanism of action suggest that this investigational agent may have the potential to delay the onset or slow the progression of HD."
According to the company, the SIGNAL clinical trial will build upon preclinical studies in an animal model of HD and safety data from a Phase I dose-escalation clinical trial of VX15 in MS patients that we completed last November.