SAN DIEGO — Headlining a top Alzheimer’s conference this week, the pharmaceutical company Biogen will for the first time share the data that led to a decision to reverse itself and seek approval for a highly anticipated experimental drug that it killed earlier in the year.
The drug, aducanumab, was pulled from clinical trials in March after the company and its partners said it had failed a futility analysis. But about six weeks ago, Biogen reversed itself, saying that further data analysis showed that patients who had received high levels of aducanumab “experienced significant benefits” in memory and general cognition.
Biogen will present the results of that data analysis on Thursday morning at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in San Diego. Being Patient is in San Diego to cover CTAD, the Biogen announcement and reports from other researchers and policy makers.
Here are some other conference highlights we’re looking out for:
HARMONY Trial on Pimavanserin Drug
— An update on the HARMONY trial, which is studying the drug Pimavanserin and its impact on Alzheimer’s-related delusions. In September, ACADIA Pharmaceuticals announced that it was ending its phase 3 trials because the drug had proven so effective in combating delusions.
SPRINT-MIND Trial on Blood Pressure
— A symposium focused on the SPRINT-MIND trial looking at the relationship between intensive blood pressure control and cognitive function.
Upcoming NIA Clinical Trials
— A report from Eliezer Masliah, Director of the Division of Neuroscience at the National Institute on Aging (NIA), about potential new targets could be explored in the hunt for an effective Alzheimer’s treatment.
MAPT Trial on Exercise and Cognitive Function
— A five-year update on participants of the Multidomain Alzheimer’s Preventive Trial (MAPT), which is testing whether nutritional counseling, physical exercise and cognitive stimulation, is effective in slowing Alzheimer’s and other dementias.
The report from Biogen and partners, however, is drawing the most attention, turning what STAT News described as a typically “sleepy” conference into a blockbuster that is drawing worldwide attention.
On October 22, Biogen stunned the Alzheimer’s community by announcing that it was reversing itself and seeking approval from the FDA for aducanumab, which targets the build-up of amyloid in the brain.
In addition to memory and general cognition benefits, Biogen said that study participants who had received high levels of the drug “also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping and doing laundry and independently traveling out of the home.”
In the weeks leading up to the conference, Biogen and analysts have been discussing the expected results. Two weeks ago, Biogen’s top scientist dismissed outside criticism and said he fully expected the FDA to approve aducanumab.
“I believe the drug works,” Dr. Al Sandrock, Biogen’s head of research and development and chief medical officer, told a gathering sponsored by STAT News. “I’m very excited about the prospect of getting the drug approved.”
Sandrock told the STAT news forum that Biogen had shared its data on aducanumab with the FDA during two meetings held in June and October. After the second meeting, Sandrock said that the FDA told Biogen it was “reasonable” to file for the drug’s approval.
In contrast, a respected biotech analyst told CNBC that he is skeptical that aducanumab will be approved by federal regulators.
Baird Analyst Brian Skorney told investors that aducanumab “falls really far short” of the FDA’s standards of showing substantial proof that a proposed drug will work. “We do not think that data validates anything near receiving approval from the FDA,” Skorney said.