BioVie Announces Pipeline Update and Near-Term Clinical Priorities
BioVie Inc. secures funding for Parkinson's Disease and Alzheimer's Disease trials, prepares for Phase 2b trial of NE3107, and plans Phase 3 trial for BIV201. The company aims to focus on clinical priorities in neurological disorders and liver disease, with positive results from NE3107 in PD and AD. Financially, BioVie increased its cash balance by $18.8 million after closing an equity financing round for gross proceeds of $21 million.
BioVie Inc.'s announcement of successfully completing a financing round, securing $18.8 million net, is a strategic capital infusion that bolsters the company's financial runway. With the funds earmarked for advancing clinical trials in Parkinson's Disease (PD) and Alzheimer's Disease (AD), investors should note the potential for increased R&D expenditures in the near term. The pivotal Phase 2b trial for NE3107 in PD, slated for initiation in late summer 2024, is particularly noteworthy as a catalyst for mid-2025 when topline results are anticipated. The company's assertive positioning of NE3107 as a first-line monotherapy for PD could disrupt the current standard of care, which has remained largely unchanged for over fifty years since the introduction of levodopa.
Moreover, the strategic decision to delay the AD program to leverage a new once-daily formulation of NE3107 underscores management's focus on long-term value creation through product differentiation and patient adherence. This could potentially enhance the drug's marketability and competitive edge. However, the delay also implies a longer time-to-market for the AD treatment, which investors should weigh against the near-term PD trial developments. The advancement of BIV201's Phase 3 trial for ascites, pending partnership funding, could represent a diversification of BioVie's pipeline, yet the reliance on external funding introduces uncertainty that must be factored into the company's risk profile.
The clinical data presented on NE3107's efficacy in treating PD and AD is promising, with significant improvements in both motor and non-motor symptoms and a potential neuroprotective effect. The planned use of a Bayesian trial design for the Phase 2b PD trial allows for adaptive decision-making, which could expedite the trial process and reduce associated costs if efficacy is demonstrated early. This innovative approach to clinical trial design is becoming more prevalent in the industry and could be a differentiator for BioVie's PD program.
For AD, the reported slowing of decline across various cognitive and functional scales suggests that NE3107 could be a significant contender in a market with a high unmet need. The focus on a once-daily formulation may improve patient compliance, a common challenge in chronic disease management. The potential implications of these developments on patient outcomes and healthcare costs are substantial, considering the prevalence and impact of neurodegenerative diseases.
The therapeutic landscape for PD and AD is highly competitive, with several major pharmaceutical companies vying for market share. BioVie's strategy to position NE3107 as a first-line monotherapy for PD could capture a significant portion of the market if the drug demonstrates superior efficacy or safety compared to existing treatments. The emphasis on non-motor symptom improvement is a differentiation factor, as these symptoms are often under-addressed by current therapies. Similarly, for AD, the focus on a once-daily formulation could meet a market demand for more convenient treatment regimens.
Regarding BIV201, the focus on early-stage ascites treatment post-acute kidney injury (AKI) could tap into a niche market segment. The Orphan and Fast Track designations by the FDA suggest a streamlined regulatory pathway, which could facilitate quicker market entry and offer a competitive advantage. The company's search for a partnership to fund the Phase 3 trial is a strategic move that could mitigate financial risk while leveraging external expertise in drug development and commercialization.
03/11/2024 - 08:00 AM
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 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 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 50% in those that completed treatment. The company has received the feedback needed from the U.S. Food and Drug Administration (FDA) 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 (AKI) – 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.
“Prioritizing the Parkinson’s program allows us to focus limited resources on the trial that should provide topline results by mid-2025, create a significant catalyst for the Company, and potentially lead the way to the first new therapy for PD since the advent of levodopa over five decades ago,” commented Cuong Do, BioVie’s President and CEO. “We have great hopes for the Alzheimer’s program, but resources and the expected availability of a once-daily version of NE3107 makes delaying a year the best solution for patients and shareholders. BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete. We look forward to partnering this program with a company interested in developing the first potential treatment for ascites and related complications potentially at an earlier stage of cirrhosis.”
About BioVie
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company conducted and reported efficacy data from its randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S. FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit http://www.bioviepharma.com/ .
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. In this press release, forward-looking statements include, but are not limited to, the potential impact of NE3107 on cognition and function among study participants and topline data from the NE3107 trial and the Company’s estimate of clinical trial progress for its product candidates. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
For Investor Relations Inquiries:
Contact: Bruce Mackle Managing Director LifeSci Advisors, LLC bmackle@lifesciadvisors.com
For Media Inquires Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com
1 Palumbo et al. Improvement of Non-Motor Symptoms with NE3107 Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study. Presented at the International Conference on Alzheimer’s and Parkinson’s Diseases 2024 held March 5-9, 2024 in Lisbon, Portugal. 2 Philippens et al. Effects of NE3107 Anti-inflammatory Treatment on Motor Activity and Neurodegenerative Features of Parkinson’s Disease in a Marmoset Monkey Model. Presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders held August 27-31, 2023 in Copenhagen, Denmark. 3 ADAS-Cog12 = 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (lower is improvement); ADCOMS = Alzheimer’s Disease Composite Score (lower is improvement); ADCS-ADL = Alzheimer’s Disease Cooperative Study-Activities of Daily Living (is higher improvement); ADCS-CGIC = Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (lower is improvement); CDR-SB = Clinical Dementia Rating, Sum of Boxes (lower is improvement), MMSE = Mini Mental State Examination (higher is improvement). 4 Reading et al. Clinical Outcomes from a Phase 3, Randomized, Placebo-Controlled Trial of NE3107 in Subjects with Mild to Moderate Probable Alzheimer’s Disease. Presented at AD/PD™ 2024.
What are BioVie Inc.'s plans for NE3107 in Parkinson's Disease?
BioVie Inc. plans to conduct a Phase 2b trial for NE3107 as first-line monotherapy for recently diagnosed PD patients needing symptomatic therapy for the first time.
What data was presented for NE3107 in Alzheimer's Disease at AD/PD™ 2024?
Data presented at AD/PD™ 2024 showed that NE3107-treated patients saw improvements compared to placebo on various measures, including CDR-SB, ADAS-COG-12, ADAS-CGIC, ADCOMS, MMSE, and ADCS-ADL.
What is the status of BIV201 in ascites treatment?
BioVie Inc. terminated its Phase 2b trial for BIV201 in refractory ascites after showing positive results in reducing ascites fluid buildup. The company is preparing for a Phase 3 trial with Orphan and Fast Track designations.
How much did BioVie Inc. increase its cash balance by?
BioVie Inc. increased its cash balance by approximately $18.8 million after closing an equity financing round for gross proceeds of $21 million.
When is the expected launch of the once-daily NE3107 formulation for the Phase 3 trial in Alzheimer's Disease?
The once-daily NE3107 formulation is expected to be available in early-to-mid 2025 for the Phase 3 trial in Alzheimer's Disease.
