BioVie gets stock bump on small, midphase Alzheimer's data drop

BioVie has drummed up investor enthusiasm for its Alzheimer’s disease prospect NE3107, reporting data from an investigator-initiated phase 2 clinical trial that sparked a 39% increase in its share price. 

Neurological Associates of West Los Angeles primarily designed the clinical trial to look at the effect of taking NE3107 twice a day for three months on five imaging endpoints. The five primary outcomes listed on all relate to changes tracked using functional magnetic resonance imaging. NE3107 is a synthetic derivative of androstenetriol designed to modulate neuroinflammation and insulin resistance.

BioVie focused its statement about the results of the 23-patient study on secondary endpoints, noting that quantitative scoring of imaging data is currently underway. The imaging data detailed in the release are limited to analyses of how the 17 participants with mild cognitive impairment to mild Alzheimer’s fared on three measures.

In the subpopulation, 24% of patients had increased blood flow in the brain while 6% declined. BioVie said “41% to 47% had reduced the hyperactivation associated with cognitive impairment that results when the hippocampus (part of the brain that plays a major role in learning and memory) is stressed while 6% declined.” Levels of glutathione—a regulator of oxidative stress—rose in 41% of patients and declined in 35% of participants.   

BioVie presented the imaging results alongside data from secondary endpoints that looked at cognition and some non-imaging biomarkers. Assessed on the ADAS Cog12 cognition scale, a primary endpoint in BioVie’s ongoing phase 3 trial of the drug, 61% of patients improved over the course of the study with a mean change of -1.04. The result was not significant. 

NE3107 performed better in patients with mild disease on both the ADAS Cog12 and the Global Rating of Change. On the change scale, clinicians saw improvements in 94% of participants with mild disease. Almost 90% of patients scored themselves as improved on the scale. 

Given the small size of the trial and the extensive history of phase 2 improvements failing to translate into pivotal studies, there is scope to question whether the results say anything meaningful about the chances of NE3107 moving the needle in its ongoing phase 3 trial, which is due to read out in mid-2023. Also, BioVie saw the biggest changes in participants with mild disease, while the phase 3 is enrolling mild to moderate patients. 

BioVie’s stock was trading up 39% to $4.70 premarket on Sept. 7.