Vaccinex Inc. (NASDAQ:VCNX) has announced that it is on track to finalize the potentially vital SIGNAL study in Huntington’s Disease (HD) on time despite the numerous challenges it has faced due to COVID-19.
Vaccinex to finalize evaluation of remaining SIGNAL study subjects
So far, the company has collected primary efficacy data from subjects that finalized the trial except for two participants whose evaluation was curtailed by the coronavirus pandemic. Vaccinex indicated that the remaining subjects’ clinical sites have reopened and are expected to finalize efficacy evaluation towards the end of the month. The company is optimistic that they will complete the database lock by September 2020 with top-line data expected in early October, as previously projected.
Most importantly, Vaccinex has finalized positive interaction with the Neurology Division of the FDA and has already identified both the primary endpoint and secondary endpoint for the two randomized SIGNAL trial arms. The SIGNAL trial evaluated the efficacy and safety of pepinemab as a possible treatment for HD patients. HD is a neurodegenerative condition that currently doesn’t have any effective treatment.
Pepinemab shows enhanced brain metabolic activity in HD patients
Study results from the two arms showed that pepinemab was effective in cohort A which had 179 subjects, and it was well tolerated with an increase in FDG-PET signal relative to the placebo group. Subsequently, cohort B was designed based on Cohort A results, with 265 participants enrolled for treatment for 18 months.
Maurice Zauderer, the CEO and President of Vaccinex, indicated that they are pleased with the progress they have made in the potentially vital effort of producing a disease-modifying therapy for HD patients. Zauderer explained that Cohort A data has shown that pepinemab can enhance brain metabolic activity, as shown by FDG-PET imaging. This is a biomarker that associates with cognitive decline in neurodegenerative diseases. He added that for now believes that its Huntington’s disease program is ahead of other programs by two or more years in using alternative techs that are ready to receive clinical proof of concept.