BIIB080 Study in Healthy Adults

Overseen By Global Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Must not be taking: Prescription medications, Over-the-counter medications

Disqualifiers: Cardiac, Neurologic, Psychiatric, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a new drug, BIIB080, spreads in the brain and spinal cord, potentially aiding in Alzheimer's disease treatment. Researchers use a PET scanner to track a small, radiolabeled dose of the drug after injection into the spine. They also assess the safety of this combination in healthy adults. Participants must be healthy and free of conditions affecting spinal fluid or issues with MRI or PET scans. As a Phase 1 trial, participants will be among the first to receive this treatment, helping researchers understand its effects in people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any prescription medications (except hormone therapy), over-the-counter medications (except acetaminophen), and dietary or herbal supplements at least 28 days before the study and during the study.

Is there any evidence suggesting that BIIB080 is likely to be safe for humans?

Research shows that BIIB080 has been generally well-tolerated in earlier studies, with most side effects reported as mild to moderate. This treatment targets tau, a protein linked to Alzheimer's disease. For those concerned about safety, studies so far mostly report mild side effects, offering some reassurance. However, ongoing research aims to better understand its overall safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BIIB080 because it offers a new approach to treating neurological conditions by using a novel radiolabeled delivery system. Unlike traditional treatments that may not precisely target affected areas, BIIB080 is administered via an intrathecal injection, which delivers the drug directly into the spinal fluid, potentially enhancing its effectiveness. This method allows the radiolabeled compound, [89Zr]Zr-DFO-BIIB080, to accurately track and target specific areas of interest in the central nervous system, offering a more precise treatment option. This targeted delivery could lead to improved outcomes and fewer side effects compared to existing therapies.

What evidence suggests that BIIB080 might be an effective treatment for Alzheimer's?

Research shows that BIIB080 targets tau proteins, which play a role in Alzheimer's disease. Studies have found that this drug lowers tau levels in the brain, offering promise for slowing Alzheimer's progression. In earlier trials, individuals with moderate Alzheimer's showed positive changes in tau biomarkers, indicating disease activity. Patients have also tolerated the drug well, experiencing mostly mild to moderate side effects. These findings suggest that BIIB080 could help manage Alzheimer's symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI of 18-30 kg/m^2. Men must use effective contraception, and women cannot be able to bear children. It's designed to understand how a potential Alzheimer's drug behaves in the body.

Inclusion Criteria

I am a healthy adult with a BMI between 18 and 30.

I am using a highly effective method of birth control.

I cannot become pregnant.

Exclusion Criteria

My MRI does not show any conditions that could risk my safety in the study.

Severe allergic or anaphylactic reactions/systemic hypersensitivity to BIIB080 or any component of the study treatment

Alcohol or substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of a small dose of radiolabeled BIIB080 and a dose of BIIB080 via an intrathecal injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and biodistribution of the radiolabeled drug using PET imaging

8 days

4 visits (in-person) on Days 1, 2, 5, and 8

Long-term safety monitoring

Participants are monitored for adverse events and serious adverse events

Up to 197 days

What Are the Treatments Tested in This Trial?

Interventions

• BIIB080

Trial Overview Researchers are testing BIIB080, an experimental Alzheimer's drug, by tracking its distribution in the brain and spinal cord using PET scans after injecting it alongside a radiolabeled version called [89Zr]Zr-DFO-BIIB080.

How Is the Trial Designed?

Group I: [89Zr]Zr-DFO-BIIB080 + BIIB080 Experimental Treatment 2 Interventions

Participants will receive a single injection of a small dose of radiolabeled BIIB080 (\[89Zr\]Zr-DFO-BIIB080) along with a dose of BIIB080 together via an intrathecal (IT) injection.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05399888

NCT05399888 | A Study to Learn About the Safety of ... In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild ...

2. investors.biogen.com investors.biogen.com/news-releases/news-release-details/biogens-investigational-tau-targeting-therapy-biib080-receives

Biogen's Investigational Tau-Targeting Therapy BIIB080 ... BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11712482/

The First Gene Therapy for Patients with Alzheimer's Disease BIIB080, as a tau synthesis reduction drug, demonstrated promising results on tau biomarkers in individuals with moderate AD, along with favorable tolerability.

4. ir.ionis.com ir.ionis.com/news-releases/news-release-details/biogen-and-ionis-report-positive-topline-clinical-data

Biogen and Ionis report positive topline clinical data on ... All adverse events were mild to moderate in severity with no serious adverse events occurring in any patients that received BIIB080. There were no deaths, dose- ...

5. clinicaltrials.eu clinicaltrials.eu/inn/biib080/

BIIB080: A Promising Drug for Alzheimer's Disease ... This article explores the ongoing research into BIIB080, focusing on its safety, efficacy, and how it may impact symptoms in patients with mild cognitive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06454721

NCT06454721 | A Study to Determine the Biodistribution ... A Study to Determine the Biodistribution, Safety, and Tolerability of a Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults.

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2810958

Exploratory Tau Biomarker Results From a Multiple ... As previously published, BIIB080 was generally well tolerated. The majority of adverse events were mild or moderate in severity, of which the ...

8. humanforschung-schweiz.ch humanforschung-schweiz.ch/de/studiensuche/studien-detail/62704/translate/en/?cHash=fda054b7d37c8567eabb1d9d4c69ca13

A randomized study to assess the efficacy, safety, and ... This study investigates the effect of BIIB080 on mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia. Beta-amyloid- ...