Vaccinex has completed subject enrollment for the SIGNAL trial, which is a phase 2, multi-center, randomized, double-blind, placebo controlled study in subjects with early manifest and late prodromal Huntington’s disease (HD) to assess the safety, tolerability, pharmacokinetics, and efficacy of VX15/2503 (pepinemab).
In June 2015, Vaccinex, the Huntington Study Group (HSG), and the University of Rochester’s Clinical Trials Coordination Center (CTCC) launched SIGNAL, the first clinical trial to investigate a monoclonal antibody as a potential treatment for Huntington’s disease (HD).
The SIGNAL study consists of two Cohorts, A and B. Cohort A was completed in February 2017 and consisted of 36 participants who were randomized to receive monthly infusions of either VX15/2503 (pepinemab) or placebo for six months in a double-blind fashion.
All participants in Cohort A subsequently received open-label VX15/2503 (pepinemab) for another five months, followed by a three-month safety follow-up.
No concerning safety signals were identified. VX15/2503 (pepinemab) treatment showed marked effects on FDG-PET imaging, a measure of brain metabolic activity. VX15/2503 (pepinemab) was favored in all brain regions examined, with median increase in FDG uptake from baseline of 8.6 percent (range: 0.5-20.4 percent) compared to placebo control achieving significance (p<0.05) in the majority of frontal and parietal brain regions analyzed.
A number of prior studies have demonstrated that loss of FDG-PET signal correlates with cognitive decline in Alzheimer’s disease. SIGNAL is the first clinical study in HD to investigate potential correlation between FDG-PET and clinical outcomes.
Cohort B, now fully enrolled, includes two cohorts with a total of 265 HD subjects – 179 in group 1 (B1) who have early manifest disease and 86 in group 2 (B2) who are late prodromal. All subjects are randomized to receive monthly infusions of either VX15/2503 (pepinemab) or placebo for 18 months in double-blind fashion without crossover.
“We are gratified to have reached this important milestone of completing enrollment for the SIGNAL trial. Because of the efforts of HSG, CTCC, clinical site investigators and staff, and most importantly subject volunteers and their families, SIGNAL is several years ahead of any other ongoing advanced clinical trial testing possible disease modifying effects in Huntington’s disease. We are excited to be in the lead and hopeful of bringing relief to the patients and families who suffer this devastating disease,” said Maurice Zauderer, president & CEO, Vaccinex.
Source: Company Press Release