|BioVie Issues Letter to Shareholders|
|By: GlobenewsWire - 04 Oct 2022||Back to overview list
CARSON CITY, Nev., Oct. 04, 2022 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today issued the following letter shareholders:
We are very excited about the data from an exploratory study we supported and hope that it will set the stage for what we may see in the Phase 3 trial for NE3107 in mild- to moderate-Alzheimer’s Disease (AD) patients that should read out in mid-2023. Thus, I’ve prepared this shareholders’ letter to explain our excitement and to provide updates on our other programs.
In short, the preliminary data from this study suggests that 82% of MCI and mild AD patients treated with NE3107 over 3 months improved their cognition (as measured by a modified ADAS-Cog12 score). The mean improvement was -2.6 points (p=0.0046) for all MCI and mild AD patients and -3.5 points (p=0.0004) among the 82% responders. We believe these results, and in particular this level of improvement, confirm NE3107’s status as one of the most promising agents in development for AD.
The company financially supported and supplied drug product for an Investigator-Sponsored Phase 2 exploratory biomarker study led by Dr. Sheldon Jordan, founder of the Regenesis Project, to explore NE3107’s impact on inflammation and insulin resistance and how it may affect other biomarkers of interest to the AD research community. NE3107 was administered by an expert neurologist in a “real world” clinical setting to individuals with documented ongoing memory deficits despite medical intervention. This study has been completed, and initial topline results have been released.
BioVie has always held – and the data from thousands of publications suggest – that Alzheimer’s disease pathology is driven by multiple factors. The AD research community has focused on Amyloid Beta (Ab) and phospho-tau (p-tau) for decades, but few Ab and p-tau agents have been shown to have significant impact on cognition. We believe that focusing on any single factor such as Ab and p-tau is insufficient, and that dysregulation in the AD brain is driven by inflammation, insulin resistance, metabolic dyshomeostasis, oxidative stress, and other factors in addition to Ab and p-tau. The common thread among all these factors is neuroinflammation, which is initiated by TNFa. Preclinical and clinical trials have shown that NE3107 modulates the production of TNFa – the major regulator of inflammation – and reduces insulin resistance. This recently completed exploratory biomarker study provides the first glimpse into how the reduction of inflammation and insulin resistance correlates with improvements in cognition, blood flow and metabolism in the brain for some patients, and Ab and p-tau.
You may recall that NE3107 was first brought to the clinic as an anti-inflammatory type 2 diabetes treatment. Phase 1 and 2 trials showed that NE3107 decreased insulin resistance, postprandial glucose and HbA1c compared to placebo – a profile you would want for a potential diabetes drug. Interestingly, patients treated with NE3107 also saw decreased systems dysregulation of inflammatory, hematopoietic and metabolic parameters compared to placebo. Subsequently, others published that this type of inflammation-driven systems dysregulation that NE3107 modulated is associated with Alzheimer’s. Since NE3107’s mechanism of action (MOA) was not fully understood at the time, we couldn’t fully explain why this was observed. Lastly, treated patients showed no differences in adverse events compared to placebo, suggestive of an acceptable safety profile.
Through additional research, we came to learn that NE3107 has a very unique and unexpected MOA. It turns out that NE3107 modulates the activation of the extracellular regulated kinase (ERK) into its active form (called p-ERK), thereby interfering with p-ERK’s activation of inflammatory nuclear factor kappa B (NFkB). Reduced activation of NFkB leads to the reduced production of TNFa. Once our team figured out NE3107’s MOA, we realized that NE3107 potentially plays a critical role in modulating the inflammatory process at a critical juncture right before the production of TNFa and thus has the potential to disrupt the proinflammatory cascade in AD and dementia. With this understanding, the company pivoted from diabetes to Alzheimer’s.
The recently completed open label trial enrolled 23 patients – 17 of whom are considered to have mild cognitive impairment or mild Alzheimer’s while 6 have moderate AD as measured by their Mini Mental State Examination (MMSE) score. The trial used advanced imaging techniques and examined cerebrospinal fluid and blood biomarkers to compare what happened to patients before and after 3 months of treatment with NE3107. I must stress this is a small open label study, thus it cannot detect the magnitude of the placebo effect as a double-blinded, placebo-controlled trial could. But we are encouraged by the totality of the preliminary data and summarize the findings below.
We are encouraged by the data showing that 82% of MCI and mild AD patients had improvements in their modified ADAS-Cog12 score, with a mean improvement of -2.6 points (p=0.0046) or roughly 25% improvement from baseline (p=0.0026). Among this group of the 82% responders, the mean improvement was -3.5 points (p=0.0004) on the ADAS-Cog12 scale. An improvement is represented by a lower disease score while a decline is represented by a higher score.
While it is difficult to make direct comparisons between NE3107’s impact on ADAS-Cog to other agents due to differing study designs, treatment durations and patient populations, the proportion of responders and level of improvements seen for NE3107 in this trial demonstrate that NE3107 shows great potential. For some perspective, below are summaries of the results of the most recent clinical studies for Alzheimer’s disease.
Although additional randomized, controlled studies are required to draw clinically meaningful conclusions, when the data is taken in its totality, it suggests that certain changes may be taking place in the brain that are consistent with NE3107’s mechanism of action and are unlikely to be accounted for by placebo effects.
All of this gives us encouraging signs of what we will hopefully see from our Phase 3 in AD that is expected to read out mid-2023.
You can watch and download the full presentation of the initial findings at: https://bioviepharma.com/topline-results/. Further hypothesis testing and data analysis continue, and all findings will be presented by the Principal Investigator and his team at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference, to be held in San Francisco, CA November 29-December 2, 2022
We also have three other trials underway that should read out over the next 12 months:
Overall, we are very excited with the progress of our clinical programs and the progress towards the potential of advancing meaningful therapies for our patient communities. We expect to provide two significant data updates later this year: 1) the full data presentations from the investigator-sponsored exploratory biomarker study at CTAD; and 2) topline data readout from the Parkinson’s Phase 2 before year-end. We are also looking forward to an exciting 2023 as we finalize the Alzheimer’s Phase 3 and the ascites Phase 2b, both of which are expected roughly mid-year.
I hope you share our enthusiasm for how the programs are advancing and the potential for exciting catalysts over the next year. We thank you for your support.
President & Chief Executive Officer
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating conditions. 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 is conducting a potentially pivotal Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028) and is targeting primary completion in mid-2023. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) is enrolling patients and expects to have topline data readout by the end of 2022. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis with top-line results anticipated in mid-2023. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in about 40 countries for related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information, visit http://www.bioviepharma.com/.
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. 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, 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:
LifeSci Advisors, LLC
Photos accompanying this announcement are available at
1 Cassava Corporate Presentation – September 13, 2022
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