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BioVie Announces Completion of Last Patient Treatment Visit in Phase 3 Trial of NE3107 in Mild to Moderate Alzheimer's Disease
Expects to announce topline data expected in the November/December timeframe.Enrolled patients had underlying medical conditions that are known risk factors
About this update from Biovie Inc.
[{"type":"text","content":"Expects to announce topline data expected in the November/December timeframe.Enrolled patients had underlying medical conditions that are known risk factors for dementia that NE3107 has the potential to improve. CARSON CITY, Nev., Sept. 26, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the last patient has completed the last visit at week 30 in its multicenter, randomized, placebo-controlled Phase 3 study (NCT04669028) of NE3107 in patients with mild to moderate Alzheimer’s Disease (AD). “Now that the last patient has completed the last treatment visit, our clinical team can begin the process leading to database lock,” stated Dr. Joseph Palumbo, BioVie’s Head of R&D and Chief Medical Officer. “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.” “We are cautiously optimistic about what to expect later this year based on data previously seen from our Phase 2 exploratory biomarker trial,” commented Cuong Do, BioVie’s President and CEO. “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. 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.” The Company’s clinical monitors have started the process working with each clinical site to ensure that the electronic data capture (EDC) database properly reflects the assessments captured during the various clinical visits. This is the critical first step to creating and locking the database for anal...