BIVI - BioVie Announces Pipeline Update and Near-Term Clinical Priorities | Benzinga
Recently completed financing provides sufficient funds for near-term Parkinson's Disease priority
Plans for Phase 2b trial of NE3107 as first-line monotherapy for Parkinson's Disease being finalized with targeted launch late-summer 2024
Once-daily NE3107 formulation expected to be available early 2025 and will be used for
Phase 3 trial in Alzheimer's Disease
Phase 3 trial for BIV201 in preparation following FDA feedback with guidance on development path; program delayed pending partnership funding
CARSON CITY, Nev., March 11, 2024 (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 its recently completed funding round provides opportunity to further the Company's clinical priorities in Parkinson's Disease (PD), Alzheimer's Disease (AD), and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators.
Parkinson's Disease
As presented at the International Conference on Alzheimer's and Parkinson's Diseases 2024 (AD/PD™ 2024) this past weekend in Lisbon, Portugal, patients with moderate and severe PD treated with NE3107 appear to have experienced significant improvements in non-motor symptoms and motor control while placebo-treated patients worsened.1 Furthermore, previous preclinical studies have shown NE3107 has a neuroprotective signal, whereby marmosets treated with NE3107 retained nearly twice as many dopaminergic neurons at the end of study compared to the untreated controls.2
Based on these findings, the Company is planning a Phase 2b for NE3107 as first-line monotherapy for recently diagnosed PD patients needing symptomatic therapy for the first time. The trial targets enrolling 100-150 patients in a 6-month trial with the Part 3 (motor) score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) as the primary endpoint. The Bayesian trial design allows an independent data monitoring board to stop the trial as soon as the treatment arm achieves the defined 4-5 points advantage compared to placebo on the UPDRS motor score. The Company anticipates initiating this trial in the late summer of 2024.
Alzheimer's Disease
In AD, data presented at AD/PD™ 2024 suggest that NE3107-treated patients saw an advantage compared to placebo of -0.95 (68% slowing of decline) on CDR-SB, -0.94 (26%) on ADAS-COG-12, -0.43 (139%) on ADAS-CGIC, -0.03 (27%) on ADCOMS, +1.02 (40%) on MMSE, and +3.08 (47%) on ADCS-ADL.3 Significant improvements on a number of biomarkers were also observed for treated patients compared to placebo.4 Due to the encouraging trending data, the Company intends to repeat the Phase 3 trial for NE3107 in patients with mild- to moderate-AD in early 2025 to take advantage of progress with a once-daily (QD) formulation of NE3107. The new QD formulation is expected to be ready in early-to-mid 2025, and the Company believes this is the more desirable presentation of the drug to help increase treatment adherence.
Ascites
The Company terminated its Phase 2b trial for BIV201 ...