United States-based Vaccinex has completed patient recruitment for the SIGNAL trial, a phase two multi-centre, randomised, double-blind, placebo controlled study in subjects with early manifest and late prodromal Huntington's disease to evaluate the safety, tolerability, pharmacokinetics, and efficacy of VX15/2503 (pepinemab), it was reported on Friday.
The SIGNAL study includes two Cohorts, A and B. Cohort A was completed in February 2017 and included 36 participants who were randomised 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.
Cohort B, now fully enrolled, covers two cohorts with a total of 265 Huntington's disease subjects – 179 in group 1 (B1) who have early manifest disease and 86 in group 2 (B2) who are late prodromal. All subjects are randomised to receive monthly infusions of either VX15/2503 (pepinemab) or placebo for 18 months in double-blind fashion without crossover.
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