Biogen’s Recent Study Results Support Amyloid Hypothesis

Earlier this month Biogen released results from its recent Phase 2B study of BAN2401. BAN2401 is an anti-amyloid beta protofibril antibody being developed for Alzheimer’s disease in collaboration with Eisai. Efficacy of BAN2401 was analyzed after 18 months of administration. Results were encouraging, showing statistical significance in the slowing of disease progression and in reduction of amyloid in the brain in subjects treated at the highest dose (10mg/kg twice a month).

Efficacy of BAN2401 after 18-month administration was measured using a Alzheimer’s Disease Composite Score (ADCOMS), which combines items from the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog), the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale and the Mini-Mental State Examination (MMSE), while reduction in amyloid accumulation was measured using PET imaging. BAN2401 was also shown to be well-tolerated. The study included 856 subjects and used four dosing levels, including dosing with placebo.

While these results are promising, enthusiasm is tempered somewhat by the fact that results of the same study released at 12 months were less robust. Questions also arise over study design and effect size, but the report did cause a rise in Biogen’s stock.

GliaCure’s leadership is cautiously encouraged by these latest results, especially as they provide support for the amyloid hypothesis, which underlies the second of GC021109’s two-pronged approach to Alzheimer’s disease. This hypothesis, which has at times been called into question, suggests that reduction of amyloid in the brain results in slowing of disease progression. BAN2401 does not address the other aspect of GliaCure’s approach, which is to cause a reduction in inflammation. We also note the ongoing advantage of GliaCure’s program over the programs being developed Biogen and other major players: GC021109 can be administered as an oral dose rather than as an infusion, making it more patient-friendly.

The GliaCure team will continue to watch the Biogen program with interest, waiting for reports of the next assessment at 21 months. At the same time GliaCure is forging ahead with its own program, planning for its Phase 2 study of GC021109 for Alzheimer’s disease.