BioVie Inc. (BIVI)
Following the release of data from an investigator-sponsored Phase 2 clinical study of NE3107 in Alzheimer’s Disease, BioVie Inc. (NASDAQ:BIVI), a biotech company focused on neurological and liver illnesses, increased by 21% in pre-market trading on Wednesday (AD).
The open-label trial had 23 patients who took 20 mg of NE3107 twice daily for three months. It was directed by Dr. Sheldon Jordan, an adjunct Clinical Associate Professor of Neurology at UCLA and its principal investigator.
At least 17 individuals had MMSE (Mini-Mental State Examination) scores of at least 20, indicating mild cognitive impairment [MCI] to mild AD. According to preliminary findings, NE3107 improved cognition, inflammatory biomarkers, and AD, with a higher improvement reported in patients with MMCI and mild AD.
A 2.6-point decline in the ADAS-Cog12 rating scale was observed in 82% of the 17 patients with MMSE >=20 (p=0.0046), which is an important finding.
94% of 17 patients with MMSE >=20 demonstrated improvements from baseline as judged by the clinician’s Global Rating of Change, a widely recognized indicator of AD development.
Regarding biomarkers, there was a statistically significant correlation between improvements in ADAS-Cog12 and lower plasma TNF in 62% of 13 MCI/mild AD patients, with a mean reduction of -0.55 pg/mL (p=0.22).
BIVI intends to present the entire dataset at the Clinical Trials in Alzheimer’s Disease (CTAD) annual meeting, which is slated for November 29 to December 2, 2022.
According to BIVI, who provided updates on numerous additional trials the business is conducting, the Phase 2b trial for BIV201 in refractory ascites is taking longer than anticipated due to the impact of COVID on patient enrolment. The business anticipates a data readout by mid-2023 since enrollments have increased recently.
By the end of 2022, full enrolment for the pivotal Phase 3 trial for NE3107 in AD is planned, and topline data is anticipated by the middle of 2023.
Additionally, BIVI expects the Phase 2 trial for NE3107 in Parkinson’s disease (PD) to reach its full enrollment target within the next few months, with a data readout anticipated by the end of the year.
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