Varoglutamstat, a drug developed by German biotech Vivoryon Therapeutcs, did not hit its primary and secondary endpoints in a Phase IIb study in Alzheimer’s disease.
Pictured: Alzheimer’s disease illustration/iStock, Artur Plawgo
Vivoryon Therapeutics announced Monday that its drug candidate to treat Alzheimer’s disease failed to reach both its primary and secondary endpoints, causing the company’s stock price to nosedive by almost 90%.
Vivoryon’s drug varglutamstat, an oral glutaminyl cyclase inhibitor, is being developed to treat early Alzheimer’s disease (AD). However, the Phase IIb VIVIAD study did not reach the primary endpoint. The results did not show a statistically significant difference in the change over time in cognition, measured by a combined score of the detection test, identification test, and the ‘one back’ test for attention and working memory.
The results also did not hit the secondary endpoints investigating cognition, instrumental activities of the daily living questionnaire and electroencephalogram global theta power.
Vivoryon said that it is performing an in-depth evaluation of the results, including the analysis of additional exploratory endpoints and other elements of the trial such as tau level, dose level and pre-treatment.
“We are profoundly disappointed by the outcome of the VIVIAD Phase IIb study of varoglutamstat in the early AD patient population given the huge unmet need for new safe and effective oral therapies,” Vivoryon CEO Frank Weber said in a statement. “While these results are not what we had hoped for, VIVIAD is a comprehensive, diligently designed and high-quality study and we are doing all we can to fully analyze the dataset as quickly as possible to gain insights into key findings that might influence varoglutamstat clinical development and help advance the science and understanding of this devastating disease.”
The company also touted that the drug was well tolerated and had low discontinuation rates related to adverse events, along with no evidence of symptomatic amyloid-related imaging abnormalities. Vivoryon said it will provide an update in April 2024 when it posts the company’s 2023 financial results.
Alzheimer’s treatments have been missing the mark as of late, with Otsuka Pharmaceuticals announcing earlier this month that its candidate, AVP-786, did not reach its primary endpoint in a Phase III trial.
However, more data readouts are expected this year for Alzheimer’s treatments such as Alector Therapeutics’ monoclonal antibody, Axsome Therapeutics’ drug designated to treat Alzheimer’s related agitation and Prothena’s fast-tracked anti-amyloid antibody, among others.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
