Biogen (BIIB) shares surged higher Wednesday after the drugmaker unveiled promising data from a late-stage trial of its developing Alzheimer's treatment just days after the reported fatality of one of its participants.
Biogen, along with its Japan-based partner Eisai Co Ltd., said the treatment, known as lecanemab, has a success rate of between 23% to 37%, compared with a placebo, in slowing the decline of cognition and daily function in the 1,800-patient trial that lasted for 18 months. The study's main goal, a reduced rate of decline as measured by the clinical dementia scale, showed a 27% success rate compared to placebo.
Side-effects, however, were also observed in some 13% of those involved in the study, which included two fatalities linked to microhemorrhages in a separate study.
Eisai said the deaths were not linked to the use of lecanemab and the Alzheimer's Association has asked the U.S. Food & Drug Administration to approve the treatment, noting it can "meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s."
"These peer-reviewed, published results show lecanemab will provide patients more time to participate in daily life and live independently," the Alzheimer's Association said. "It could mean many months more of recognizing their spouse, children and grandchildren. Treatments that deliver tangible benefits to those living with mild cognitive impairment (MCI) due to Alzheimer’s and early Alzheimer’s dementia are as valuable as treatments that extend the lives of those with other terminal diseases."
Biogen shares were marked 5.2% higher in pre-market trading to indicate an opening bell price of $306.49 each, a move that would extend the stock's year-to-date gain to around 25%.
Earlier this week, reports emerged that a woman participating in a follow-on lecanemab trial died from a brain hemorrhage linked to the drug's side-effects.
Science.org first reported the 65-year-old woman's death, noting deposits of amyloid, a protein targeted by Bigoen's lecanemab, had been found surrounding blood vessels in her brain.
Alzheimer's disease is a progressive brain disorder that affects more than 50 million people around the world. To date, no drug has been found to address the disease, which can accelerate into dementia and other more serious cognitive conditions.
Treatment pricing, however, has been a controversial issue and the U.S. Centers of Medicare and Medicaid Services noted in September that its decision to only cover treatment with Aduhelm -- Biogen's FDA-approved Alzheimer's drug -- if patients are enrolled in a clinical trial as a major factor in lowering overall premiums for Medicare Part B.
Biogen was forced to slash the price of Aduhelm by around 50%, to $28,200 per year, in order to help expand its potential reach following the CMS decision late last year.
Aduhelm, Biogen noted in earlier studies, has been show to erode amyloid beta, a plaque which builds up around the brain and can lead to neuron damage.
The FDA approved Aduhelm for the treatment of Alzheimer’s through its accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments, last year.
