ROCHESTER, N.Y. - Vaccinex, Inc. (NASDAQ:VCNX) announced today that its SIGNAL-AD clinical trial for the treatment of Alzheimer’s disease (AD) with the investigational drug pepinemab met its primary safety endpoint. The trial, focusing on patients with Mild Cognitive Impairment (MCI) due to AD, showed that pepinemab was well-tolerated with no serious treatment-related adverse events reported across 16 clinical sites.
The study also explored a secondary endpoint concerning brain metabolic activity. Over a 12-month treatment period, pepinemab demonstrated a statistically significant increase in FDG-PET imaging signal in the medial temporal cortex, a region affected by AD.
While the trial was not powered to detect cognitive effects with statistical significance, Vaccinex CEO Maurice Zauderer, Ph.D., indicated that early intervention with pepinemab might be beneficial. He noted that identifying and treating people with MCI as early as possible could extend productive life for those at risk of progressing to AD dementia.
The positive results from the SIGNAL-AD trial echo findings from a previous phase 2 study in Huntington’s disease (HD), suggesting mechanistic similarities in the pathology of AD and HD. Vaccinex has previously reported pepinemab's favorable safety profile in over 600 patients across various neurological conditions, including HD and multiple sclerosis (MS).
Amid current concerns about the limitations of approved anti-Aβ amyloid antibodies, pepinemab could present an alternative or complementary option for AD patients. The Alzheimer’s Association estimates that a significant portion of people aged 60 or older live with MCI due to AD, with a risk of developing dementia within five years.
The SIGNAL-AD study was partially funded by the Alzheimer’s Association and the Alzheimer’s Drug Discovery (NASDAQ:WBD) Foundation (ADDF). Vaccinex is actively seeking a pharmaceutical partner for late-stage development of pepinemab in AD.
InvestingPro Insights
As Vaccinex, Inc. (NASDAQ:VCNX) continues to advance its investigational drug pepinemab for Alzheimer’s disease, financial metrics from InvestingPro provide a snapshot of the company's current market standing. With a modest market capitalization of 12.77M USD, Vaccinex is a small player in the biotech industry, which could mean higher volatility and risk for investors. The company's revenue for the last twelve months as of Q1 2024 stands at a mere 0.12M USD, reflecting the early stage of its product development cycle and the challenges faced in generating sales.
InvestingPro Tips reveal that Vaccinex holds more cash than debt on its balance sheet, which is an encouraging sign for financial stability. However, the company is also quickly burning through cash, a common occurrence in the biotech sector where upfront costs are significant. Analysts predict sales growth in the current year and expect net income to grow, indicating potential optimism around the company's pipeline and its prospects for the investigational drug pepinemab.
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