J&J Halts Alzheimer's Trial After Drug Fails To Slow Clinical Decline
On Friday, Johnson & Johnson (NYSE:JNJ) said that the Phase 2b AuTonomy proof-of-concept study of posdinemab did not achieve statistical significance in slowing clinical decline in patients with early Alzheimer's disease.
The company said the study was a first-of-its-kind precision approach to evaluating targeted intervention in early Alzheimer's disease.
Following a scheduled review that determined posdinemab did not achieve statistical significance in slowing clinical decline, the Auτonomy study will be discontinued.
A full evaluation of the data will be shared with the scientific community in due course.
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In January, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to posdinemab.
Then the company said in the press release that the internally discovered mAb showed potential to target disease-associated phosphorylated tau in cerebrospinal fluid (CSF) from treated Alzheimer's disease patients and to block the development and spread of tau aggregates in non-clinical models of disease.
Posdinemab was the second Fast Track designation granted in 2024 for the company's Alzheimer's disease portfolio.
Johnson & Johnson's anti-tau active immunotherapy, JNJ-2056, the first active immunotherapy targeting tau in a preclinical AD population, was also granted Fast Track designation in July 2024.
The mid-stage study enrolled over 500 participants.
STAT News said the setback for posdinemab could cloud prospects for a wave of next-generation Alzheimer's drugs aiming to improve on current standards.
Biogen Inc. (NASDAQ:BIIB), UCB SA (OTC:UCBJY) (OTC:UCBJF), and Voyager Therapeutics Inc. (NASDAQ:VYGR) are advancing similar programs.
On Monday, Novo Nordisk A/S (NYSE:NVO) released topline results from the 2-year primary analysis of evoke and evoke+ phase 3 trials in early-stage symptomatic Alzheimer's disease.
The evoke and evoke+ trials did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer's disease, as measured by the change in Clinical Dementia Rating – Sum of Boxes (CDR-SB) score compared to baseline.
JNJ Price Action: Johnson & Johnson shares were up 0.46% at $206.99 at the time of publication on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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