Vaccinex Provides Update Of Potentially Pivotal SIGNAL Clinical Trial In Huntington’s Disease

Topline data anticipated in October 2020 as previously guided

ROCHESTER, N.Y., July 07, 2020 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in Huntington’s disease (HD) and cancer, today announced that, notwithstanding the challenges posed by the ongoing COVID-19 pandemic, it remains on track to complete the potentially pivotal SIGNAL trial in HD within the anticipated time frame. Primary efficacy data has been collected from all subjects who completed the study except for 2 subjects whose assessments were delayed by the COVID-19 pandemic, but whose clinical sites have now reopened and who are expected to complete efficacy assessments later this month. The Company continues to anticipate that database lock will be completed by September and that topline data may be released by early October as previously guided.

The Company has also completed productive interactions with the FDA Division of Neurology and has identified primary and secondary endpoints for the two randomized arms of the SIGNAL trial as detailed below.

Efficacy Analysis

The efficacy results for the 265 subjects enrolled in the SIGNAL study, all of whom were confirmed to carry the Huntington’s mutation, will be analyzed in two groups: a first group comprising 179 subjects diagnosed with early manifest disease defined by Total Functional Capacity (TFC) ≥ 11, and a second group comprised of all 265 subjects enrolled in the study that represents the continuum of disease before and after conversion to manifest symptoms. In addition to the 179 subjects with early manifest disease, this latter group includes 86 subjects deemed to be at an earlier stage of underlying disease progression, late prodromal (DCL 2 or 3). Co-primary endpoints for the first group are Clinical Global Impression of Change (CGIC) from baseline through 18 months of treatment and a family of selected cognitive assessments from the Huntington’s Disease Cognitive Assessment Battery (HD-CAB). Secondary endpoints for this group include Quantitative Motor assessments (Q-Motor) and TFC. For the consolidated group, the single primary endpoint will be TFC and secondary endpoints are Q-Motor and the selected family of HD-CAB cognitive assessments. A number of brain imaging assessments will be reported including changes in volumetric MRI, a measure of brain atrophy, and changes in FDG-PET, a measure of metabolic activity in major brain regions.

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Susan Miller 7 months ago Member's comment

Sounds promising.