Alzheimer's Drug Flop Sinks Vivoryon Shares

Vivoryon Therapeutics recently reported that its candidate medication for treating Alzheimer's disease did not achieve its main and secondary goals, leading to a significant drop in the company's stock value. The drug in question, varglutamstat, is an oral glutaminyl cyclase inhibitor intended for early-stage Alzheimer's. The Phase IIb clinical trial, known as VIVIAD, did not demonstrate a significant change in cognitive function over time when measured by a combination of various tests.

The trial's secondary objectives, which focused on cognitive function, daily living activities, and brainwave analysis, were also not met. Despite this, Vivoryon is conducting a thorough review of the study's data, including additional exploratory endpoints and factors such as tau protein levels, dosage, and pre-treatment conditions.

The company's CEO, Frank Weber, expressed deep disappointment in the study's outcome, particularly given the urgent need for new, safe, and effective oral treatments for Alzheimer's disease. He emphasized the importance of the VIVIAD study's design and quality, and the company's commitment to analyzing the data to derive insights that could influence the future development of varglutamstat and contribute to the understanding of Alzheimer's.

Vivoryon highlighted that the drug was well-tolerated with low discontinuation rates due to adverse events and no signs of imaging abnormalities related to amyloid. The company plans to release an update in April 2024 alongside its financial results for 2023.

The field of Alzheimer's treatment has faced setbacks, with Otsuka Pharmaceuticals also recently announcing that its candidate, AVP-786, failed to meet its primary endpoint in a Phase III trial. However, several other Alzheimer's treatments are in the pipeline, with data expected to be released this year, including monoclonal antibodies and drugs targeting agitation and amyloid antibodies.

The ongoing search for effective Alzheimer's treatments underscores the complexity and challenges of this devastating disease. Despite the setbacks, the scientific community continues to explore new avenues and approaches in the hope of finding breakthrough therapies.