BIVI - BioVie jumps 21% after Phase 2 data for Alzheimer's candidate

BioVie Inc. ( NASDAQ: BIVI ), a biotech focused on liver and neurological diseases, added ~21% in the pre-market trading Wednesday following an announcement on results from an investigator-sponsored Phase 2 clinical trial of NE3107 in Alzheimer’s Disease (AD).

Run by Dr. Sheldon Jordan, an adjunct Clinical Associate Professor of Neurology at UCLA as the lead investigator, the open-label trial involved 23 patients who received 20 mg of NE3107 twice daily for three months.

Seventeen patients demonstrated Mini-Mental State Examination (MMSE) scores greater than or equal to 20 indicating mild cognitive impairment [MCI] to mild AD.

The initial results indicate that NE3107 led to improvements in cognition, biomarkers of inflammation, and AD, with a greater change seen in patients with MMCI and mild AD.

Notable findings include a 2.6-point decrease in ADAS-Cog12 rating scale seen in 82% of 17 patients with MMSE >=20 (p=0.0046).

As measured by the Global Rating of Change, a widely used standard of AD progression, scored by the clinician, 94% of 17 patients with MMSE >=20 showed improvements from baseline.

Regarding biomarkers, 62% of 13 MCI/mild AD patients had decreased plasma TNF with a mean change of -0.55 pg/mL (p=0.22) which correlated with improvements in ADAS-Cog12 with statistical significance.

BIVI plans to disclose the complete data set at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference scheduled for Nov. 29 – Dec. 02, 2022.

Updating on several other trials the company is running, BIVI said that the Phase 2b trial for BIV201 in refractory ascites is taking longer than expected amid COVID impact on patient enrollment. With enrollments picking up in recent weeks, the company expects a data readout by mid-2023.

Full enrollment for the pivotal Phase 3 trial for NE3107 in AD is expected by the end of 2022, and topline data is anticipated by mid-2023.

In addition, BIVI anticipates full enrollment of the Phase 2 trial for NE3107 in Parkinson’s disease (PD) to complete within the next couple of months, with a data readout expected by the end of the year.

Read: In October, BIVI shares surged on FDA nod to start the Phase 2 trial for NE3107 in PD.

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