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.
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.
“We are very pleased with continued progress in our potentially pivotal effort to make a disease modifying therapy available to people at risk of this debilitating disease,” said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex. “The data from Cohort A suggest that pepinemab can improve metabolic activity in the brain as detected by FDG-PET imaging, a biomarker that correlates with cognitive decline in other neurodegenerative diseases. At this time, we believe the Vaccinex HD program is two or more years in advance of other programs employing alternative technologies that have not yet achieved clinical proof of concept. Because the Vaccinex strategy addresses a pathogenic mechanism common to different neurodegenerative diseases, we believe pepinemab also has potential application in Alzheimer’s disease (AD), progressive multiple sclerosis, and ALS. A phase 1/2 trial in AD supported by the Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation is expected to begin enrolling patients in September 2020.”
Source: Vaccinex, Inc