BioVie announces pipeline update, near-term priorities

BioVie announced that its recently completed funding round provides opportunity to further the Company’s clinical priorities in Parkinson’s Disease, Alzheimer’s Disease, and ascites/liver disease. The Company continues to explore longevity and aging in conjunction with external collaborators. As presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 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. 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 score on the MDS-Unified Parkinson’s Disease Rating Scale 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. In AD, data presented at AD/PD 2024 suggest that NE3107-treated patients saw an advantage compared to placebo of -0.95 on CDR-SB, -0.94 on ADAS-COG-12, -0.43 on ADAS-CGIC, -0.03 on ADCOMS, +1.02 on MMSE, and +3.08 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 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. The Company terminated its Phase 2b trial for BIV201 in refractory ascites after the study enrolled one-half of intended patients as data available showed that BIV201 reduced ascites fluid buildup by over 50% in those that completed treatment. The company has received the feedback needed from the U.S. Food and Drug Administration to finalize the remaining preclinical requirements and design the Phase 3 protocol. Only one Phase 3 trial is potentially needed as BIV201 has already received Orphan and Fast Track designations. The trial will focus on an earlier stage of the disease progression – after cirrhotic patients with ascites have experienced an acute kidney injury – to research whether BIV201 treatment can reduce the number of subsequent complications from cirrhosis and ascites. The Company increased its cash balance by approximately $18.8 million after closing on an equity financing round last week for gross proceeds of $21 million. The funds raised allow the Company to focus on launching the PD trial this summer and completing development of the NE3107 QD formulation for the AD trial in 2025.