Biomarkers support subanalysis finding
Dr. Swanson also presented new cerebrospinal fluid biomarker data showing changes in phosphorylated tau, neurogranin, and neurofilament light chain that support the overall 47% slowing of cognitive decline reported last summer. The 10 mg/kg biweekly and monthly groups were again combined to increase the sample size, but it remained quite small, with full data on 16 in the placebo group and 23 in the active group:
- Neurogranin, a synaptic protein that is a marker of neuronal damage, decreased by a median 58 pg/mL (11%), compared with a 13.5-pg/mL increase in the placebo group.
- Phosphorylated tau, a marker of tau pathology in the brain, decreased by a median 12 pg/mL (13%), compared with no change in the placebo group.
- Neurofilament light chain, a neuronal structural scaffold protein that is a marker of axonal degeneration, increased by a median 75 pg/mL in the active group, compared with a 156-pg/mL increase in the placebo group – a 48% difference.
The positive biomarker data bolstered the subanalysis to some extent, researchers felt. But in the end, Study 201 is just a first step for BAN2401, said Laurie Ryan, PhD, chief of the dementias of aging branch in the division of neuroscience at the National Institute on Aging.
“Today’s presentation gave us a new look at the trial data from the summer,” Dr. Ryan said in an interview. “The new analysis supports the findings previously released but is still preliminary. Nothing is definitive in a phase 2 study, so while it appears to suggest a potential positive, beneficial result, it needs further testing.”
Eisai has made its subanalysis presentation slides publicly available.
Dr. Swanson is an employee of Eisai. Dr. Cummings is a consultant for Eisai and Biogen. Dr. Sperling has consulted for numerous pharmaceutical companies. Dr. Rabinovici and Dr. Ryan have no disclosures.
SOURCE: Swanson C et al. CTAD, Symposium 3.