| Item
8.01 |
Other Information. |
On
December 5, 2022, the Company issued the First Press Release announcing positive results
from the investigator-sponsored exploratory Phase 2 trial of NE3107 to study of the interactions between NE3107 and levodopa (the “PD
Trial”) as well as positive results from the investigator-sponsored exploratory biomarker and imaging Phase 2 trial of NE3107 for
treatment of AD (the “AD Trial”). On December 6, 2022, the Company issued the Second Press Release announcing additional findings
from the AD Trial.
PD Trial
The NM201 study (NCT05083260) is a double-blind, placebo-controlled,
safety, tolerability, and pharmacokinetics study in Parkinson's disease (PD) participants treated with carbidopa/levodopa and NE3107.
45 patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. This trial
was launched with two design objectives: 1) the primary objectives are safety and a drug-drug interaction study as requested by the FDA
to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective is to determine if preclinical
indications of pro-motoric activity and apparent enhancement of levodopa activity can be seen in humans.
The results of the PD Trial showed:
| · | Patients treated with the combination of NE3107 and levodopa
saw improvements in their UPDRS Part 3 (motor) score that is 3+ points superior to patients treated with levodopa alone. This level of
superiority is considered to be clinically meaningful by Parkinson’s experts. |
| · | Patients under 70 years of age treated with NE3107/levodopa
experienced roughly 6 points superiority compared to those treated with levodopa alone, suggesting that younger patients with less advanced
disease progression may experience greater impact from treatment with NE3107. |
| · | 88.9% of patients <70 years old treated with NE3107 and
levodopa experienced greater than 30% part 3 score improvements from baseline at the 2-hour mark compared to 63.6% of patients treated
with levodopa alone. |
| · | The study met both of its objectives. |
Full details from this trial will be presented at
the upcoming AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases to be held March 28-April
1, 2023 in Gothenburg, Sweden.
AD
Trial
The
AD Trial— A Phase II Open-Label Study for the Use of Anti-Inflammatory, Insulin-Sensitizing NE3107 for Treatment of Cognitive Decline
Due to Degenerative Dementias (NCT05227820) — was an exploratory biomarker study conducted by Dr. Sheldon Jordan, who served as
principal investigator for the trial. The trial explored NE3107’s potential role in real-world clinical practice as an exploratory
precursor informing the design of subsequent placebo-controlled blinded studies.
The
trial enrolled a total of 23 patients – 18 patients with Mini-Mental State Examination (MMSE) scores greater than or equal to 20
(i.e., mild cognitive impairment (MCI) to mild AD) and 5 patients with MMSE <20 (i.e., moderate AD) – in an open-label, single
arm study. The trial measured changes in cognition through verbal and visual test procedures, changes in biomarkers of Alzheimer’s
disease and inflammation that can be measured in cerebral spinal fluid (CSF) and serum samples, and with functional magnetic resonance
imaging techniques in patients, before and after treatment with 20 mg of NE3107 twice daily for 3 months.
The
results of the AD Trial showed:
| · | Patients treated with NE3107
experienced enhanced cognition as measured by multiple assessment tools, including a 2.1 points improvement on the modified ADAS-Cog12
scale (p=0.0173) among MCI and mild Alzheimer’s Disease (AD) patients. |
| · | NE3107 reduces CSF phospho-tau
levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to Ab42 by -0.0024 (p=0.0401). |
| · | 18 of 22 patients with abnormal
baseline scans showed improvement in one or more brain regions as seen from advanced functional MRI studies. |
| · | No drug-related adverse events
were observed. |
The December 6, 2022 press release discussed the additional findings from
the Phase 2 trial of NE3107 for AD that the blood samples taken from the patients who participated in the Alzheimer’s Phase 2 trial
before and after 3 months of treatment with NE3107, were analyzed to assess NE3107’s potential to reduce inflammation and alter
DNA methylation associated with epigenetic biological clocks. The resulting data for patients treated with NE3107 for three months showed
a reduction of 3.3 years (p=0.0021) on the Horvath DNA methylation SkinBlood clock. Furthermore, 19 out of the 22 patients experienced
this reduction in the SkinBlood clock score. The finding that NE3107 affects the SkinBlood clock provides an impetus for the Company to
explore further the relationship between NE3107 decreasing epigenetic age and improving neurodegeneration and other inflammation-driven
diseases.
Forward-Looking
Statements
This
Current Report on Form 8-K 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 report, forward-looking statements include, but are not
limited to, statements relating to the timing of the completion of enrollment of its clinical trials and timing of date readouts with
respect thereto. 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.