BioVie Inc (NASDAQ:BIVI) said the last patient has completed their final visit at week 30 in their Phase 3 study of investigational therapy NE3107 in patients with mild to moderate Alzheimer’s Disease (AD), and it expects to announce topline data from the trial in November or December.
BioVie’s shares moved higher on the news, adding 11.4% to US$3.62 shortly before noon on Tuesday.
“Now that the last patient has completed the last treatment visit, our clinical team can begin the process leading to database lock,” Dr. Joseph Palumbo, BioVie’s head of R&D and chief medical officer, explained.
“We remain on track to announce topline data on the cognitive and functional assessments by approximately the end of November 2023 with additional biomarker data on TNFα, amyloid β, phospho-tau, Neurofilament light (NfL), and others to follow.”
BioVie CEO Cuong Do said the company was “cautiously optimistic” about the study results based on data from its Phase 2 exploratory biomarker trial.
The study’s co-primary endpoints are evaluating cognition using the AD Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the AD Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).
“We do not need to show a reversal of cognitive decline as demonstrated in the Phase 2 trial for the current trial to be considered successful. If NE3107 demonstrates a slowing of cognitive decline equivalent to or better than the various monoclonal antibodies, we win because NE3107 is an oral agent that has been demonstrated to be safe in various trials thus far,” Do said in a statement.
“Furthermore, we do not need to demonstrate efficacy and statistical significance across the board or with all the pre-specified subgroups such as mild- vs. moderate-AD, Aβ positive vs. negative, Hispanics vs. non-Hispanic, insulin-resistant vs. not, etc. A win in one or more subgroups is still a big win for the patient community and the company.”
At this time, BioVie’s clinical monitors are working with each site involved in the trial to ensure that the electronic data capture database reflects the assessments captured during the various clinical visits.
The company said this was the critical first step to creating and locking the database for analyses and eventual submission to the Food and Drug Administration (FDA) for review.
The trial’s Statistical Analysis Plan, which outlines the analyses, treatment populations and subgroups, will be submitted to the FDA before the electronic data capture is locked, BioVie added.
BioVie is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating conditions.
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