Biogen to Present New Aduhelm Data at Upcoming Alzheimer’s Conference

The annual Clinical Trials on Alzheimer’s Disease conference (CTAD) is scheduled for November 9-12, and Biogen announced plans to present data on its portfolio, including its controversial Aduhelm (aducanumab).

The U.S. Food and Drug Administration approved Aduhelm on June 7, and it’s been surrounded by controversy ever since. Sales have been disappointing, bringing in only $300,000 in the third quarter, the approval process is being investigated by Health and Human Services’ Inspector General’s Office and the price tag of $56,000 per patient per year threatens to bankrupt Medicare if it were more widely adopted.

As part of their presentations, Biogen will show data including more than 3,000 patients in Phase III clinical trials and about 1,7000 patients in the redosing trial, EMBARK, of Aduhelm. A late-breaking presentation will cover new data from more than 7,000 plasma samples from the ADUHELM Phase III clinical trials that will describe the effect of the drug on plasma phosphorylated tau181 (p-Tau181) and how it correlates to amyloid beta plaques and disease progression. Amyloid beta and tau are abnormal proteins that aggregate in the brains of Alzheimer’s patients.

“We collected an unprecedented sample size—approximately 7,000 plasma samples from more than 1,800 patients—to provide robust answers to questions about the correlation between plasma pTau reduction, amyloid beta plaque levels and clinical decline in Alzheimer’s disease,” said Maha Radhakrishnan, Biogen’s chief medical officer.

“We are eager to engage the scientific community with the findings from this comprehensive dataset. The clinical insights we can derive from our data at CTAD are meaningful. These can help inform clinician, patient and caregiver choice and future treatment decisions, as well as advance the field’s understanding of this devastating disease.”

The company also will present results from more than 1,800 patients screened for the EMBARK re-dosing study with Aduhelm. This, they say will “shed light on the impact of stopping treatment in clinical trials.”

Patients who had been enrolled in the ADUHELM trials when they were halted in 2019 later re-enrolled in the EMBARK study, even though they had been off treatment for an average of 1.7 years. Some of the patients had been receiving treatment in the PRIME Phase Ib long-term extension study for more than four years, in addition to up to 18 months in the Phase III EMERGE and ENGAGE trials.

Biogen notes, “Disease progression and amyloid beta plaque levels during this extended discontinuation of Alzheimer’s disease treatment will be examined in the Virtual Oral Presentation, ‘Baseline EMBARK data from EMERGE, ENGAGE, and PRIME participants in the EMBARK re-dosing study,’ on Tuesday, November 9, at 8:00 a.m. EST.”

Another poster will demonstrate how many people are estimated to advance daily from mild cognitive impairment from Alzheimer’s to mild Alzheimer’s and further from mild Alzheimer’s to moderate Alzheimer’s. This will underline the urgency for earlier detection, diagnosis and treatment.

The study on the effects of halting the study may be particularly interesting, given how unusual it was, despite the devastation to many of the subjects involved. Being Patient writes of one case, Geri Taylor, who had enrolled in a study in 2015 after a diagnosis of mild cognitive impairment.

Geri had seemed to be doing well on the drug. Her husband Jim Taylor told Being Patient, “We really thought the drug was helping. Of course, there’s no way to know that, but her ability to maintain normal daily activities and live and take care of herself was really excellent. We traveled all the time and she managed all that well.”

But when the trials were discontinued in March 2019, Geri Taylor and the other participants were taken off the drug. Her husband says her disease progressed faster than before. “During what I call the interregnum, the period when she wasn’t getting the medication, she started to decline more quickly,” he says. “Now that she’s back on the drug, I kind of doubt it’s helpful. The benefit is really to get started as early as possible.”

This is anecdotal, as are many patient stories, but as another of the trial participants, Phil Gutis, said, “Anecdotally, I believe that aducanumab has helped me. I feel much better than I did five years ago. Truthfully, five years ago, I didn’t expect to still be alive today.”