BIIB076 / Biogen, Neurimmune - LARVOL DELTA

Results of A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB076 in Healthy Volunteers and Subjects With Alzheimer’s Disease (CTAD 2021) - P1 | "A single dose of BIIB076 was demonstrated to be tolerated, had a dose-dependent PK profile and reduced unbound mid-region tau in CSF in HVs and Alzheimer’s disease participants."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Immunology • Pain • Psychiatry

Biogen Announces Late Breakers and Additional New Data Presentations at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting (GlobeNewswire) - “Biogen Inc…announced the company will present a variety of new data from its Alzheimer’s disease product portfolio and clinical development pipeline at the upcoming annual Clinical Trials on Alzheimer’s Disease conference (CTAD), held November 9-12 virtually and in Boston, Massachusetts…A late breaking presentation will highlight important new data from over 7,000 plasma samples from the ADUHELM Phase 3 trials that, for the first time, examines the effect of ADUHELM on plasma phosphorylated tau181 (p-Tau181) and its correlation to amyloid beta plaques and disease progression, as measured by clinical decline endpoints, in patients with early Alzheimer’s disease.”

Late-breaking abstract • P1 data • P2 data • P3 data • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease (clinicaltrials.gov) - P1; N=56; Active, not recruiting; Sponsor: Biogen; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2019 ➔ May 2019; Trial primary completion date: Apr 2019 ➔ May 2019

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • Biosimilar • CNS Disorders

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease (clinicaltrials.gov) - P1; N=46; Completed; Sponsor: Biogen; Active, not recruiting ➔ Completed

Clinical • Trial completion

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease (clinicaltrials.gov) - P1; N=46; Active, not recruiting; Sponsor: Biogen; Recruiting ➔ Active, not recruiting

Enrollment closed

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: Biogen; Trial completion date: Jul 2019 ➔ Feb 2020; Trial primary completion date: Jul 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date