Vaccinex Update on 1b/2 Alzheimer’s Trial, Plans to Pursue Development Partnership

 Vaccinex recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data related to cognitive effects that may help clarify the goals of this study, how well it succeeded, and how this success supports continued development of pepinemab in AD and other neurodegenerative diseases including Huntington’s Disease (HD), which was the focus of a larger previously completed phase 2 study.

Following completion of its phase 2 study in HD, the Company recognized that a major market and strategic focus of its potential pharmaceutical partners was AD. The Company, therefore, undertook to determine whether pepinemab had similar effects in AD as it had reported for HD. The SIGNAL-AD clinical trial was a smaller, cost-effective study in AD that focused on common features of disease progression in AD and HD, including an important efficacy endpoint, the well-characterized decline in brain metabolic activity reflected by FDG-PET signal in a key brain region that is affected early in disease. For AD, one such region, identified in multiple prior studies, is the medial temporal cortex from which disease manifestations spread to other temporal regions and, over time, to the rest of the brain. In the randomized SIGNAL-AD study, that goal was clearly reached by data showing a statistically significant difference (p=0.0297) in FDG-PET signal in the medial temporal cortex following 12-months of treatment with pepinemab compared to placebo. Pepinemab was well-tolerated in AD, consistent with prior clinical experience in HD.

The Company believes that it has compiled compelling early phase evidence of favorable tolerability and efficacy of pepinemab in neurodegenerative disease and that it is well-positioned to enter into a major partnership for continued development without a need for it to perform additional proof of concept studies. This partnership strategy would greatly reduce the Company’s operating expenses going forward.

https://www.biospace.com/vaccinex-provides-update-on-new-findings-for-signal-ad-phase-1b-2-trial-of-pepinemab-in-alzheimers-disease-and-plans-to-pursue-a-development-partnership