Alzheimer’s afflicts some 50 million people worldwide. It’s a devastating disease, both to patients and to their caregivers. For drug companies, finding a cure has been the elusive Holy Grail, explains growth stock expert Scott Chan, editor of Investing Daily's The Complete Investor.
While some drugs help manage some of the symptoms, no one has come up with a treatment that cures or stops progression of the disease. But Biogen (BIIB) — a holding in our growth portfolio — and its partner Eisai, however, have just gotten a step closer.
The two companies recently announced new results from their Phase 2 clinical study of BAN2401. Results that had been reported earlier, taken at the 12-month mark, had been unimpressive.
But a recent update at the 18-month mark found that at the highest dosage, BAN2401 showed statistically significant reduction in amyloid beta accumulation in the brain and improvements in cognitive function compared to test subjects on placebo. The 856 patients in the study are all in early stage of the disease.
A buildup of clumps of amyloid beta, a protein, is a telltale sign of Alzheimer’s. One approach in seeking a cure has been to try to reduce buildup of the protein to see if that slows, or even reverses, progression of the disease. BAN2401 is a monoclonal antibody designed to bind to amyloid beta. The hope is that tagging the protein in this way will prompt the patient’s immune system to remove it.
Phase 1 study for BAN2401, which tests for safety and tolerability, showed enough promise to proceed to Phase 2. But last December, Biogen and Eisai announced that the drug did not meet the primary endpoint at the 12-month mark. So the early July announcement was quite a positive surprise, explaining why Biogen shares recently jumped 19 in one day.
We caution that the two companies haven’t yet released the full data for review yet, and devils could lurk in the details. But given that BAN2401 had become essentially an afterthought after the disappointing December data, the surprising development is clearly great news for shareholders.
Biogen and Eisai have an even more advanced candidate for Alzheimer’s, aducanumab. It, too, is a monoclonal antibody that targets amyloid beta, but it is a different antibody than BAN2401.
Data readout isn’t expected until at least late 2019. If aducanumab and/or BAN2401 successfully win FDA approval, Biogen would have a potential monster on its hands. Peak sales could be $10 billion or more per year.
We cannot stress enough that there’s no guarantee either of Biogen’s leading Alzheimer’s candidates will pan out. Especially given drug companies’ long history of failure in finding a cure, we don’t blame anyone who’s skeptical.
After all, so far an estimated 400 clinical trials have been run to test various Alzheimer’s treatments, without success. But if anyone is going to crack the Alzheimer’s code, right now Biogen looks to be the best bet.
