Vivoryon Therapeutics has reported updates to its Alzheimer’s Disease clinical development programme being conducted in the US and the EU.
The company and the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California have created a new design for Phase IIa trial of PQ912 for Alzheimer’s in the US.
This new proposal will be submitted by the university to the National Institutes of Health.
Set to begin this year, the Phase IIa trial is expected to complete in 2023. The study is designed to enrol 180 patients, who will be given PQ912 or a placebo orally over six months.
The trial will include a drug-titration phase, an early cognitive efficacy read-out, analysis of parallel dose responses, and a composite Neuropsychological Test Battery (NTB) score to determine cognitive efficacy.
Electroencephalography (EEG) and cerebrospinal fluid (CSF) biomarkers data is expected to support the Phase IIb EU trial, named VIVIAD. Vivoryon noted the Phase IIa trial is intended to act as a stage gate to Phase IIb study.
The Phase IIa study is supported by the NIH’s National Institute on Aging (NIA) grant awarded in March last year for the project. Vivoryon will be responsible for the remaining financial needs, manufacturing costs and drug supply chain management of PQ912 and placebo.
Vivoryon Therapeutics CEO Ulrich Dauer said: “The importance of study design, particularly in a disease like Alzheimer’s, cannot be underestimated.
“As such, the opportunity to update the US clinical trial protocol will enable us to further expand the framework in which we evaluate and gather information on PQ912.
“These results ultimately add to the growing body of data on this compound’s potential in patients with Alzheimer’s.”
The company received approval from the World Health Organization (WHO) for PQ912’s International Nonproprietary Name (INN) as varoglutamstat.