Building on decades of the Company's
Alzheimer's research, two differentiated investigational therapies
aim to slow pathological tau in distinct populations
Fast Track designations reinforce J&J's
commitment to Alzheimer's disease development and the potential of
its precision approach
TITUSVILLE, N.J., Jan. 8, 2025
/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation to posdinemab, a phosphorylated tau-directed
monoclonal antibody (mAb) being investigated to treat patients with
early Alzheimer's disease (AD) in the Phase 2b "AuTonomy" study. The internally
discovered mAb has shown the potential in targeting
disease-associated phosphorylated tau in cerebrospinal fluid (CSF)
from treated AD patients, and in blocking the development and
spread of tau aggregates in non-clinical models of disease.
"As the average age of the global population increases, the
number of people impacted by this debilitating progressive disease
continues to rise. Alzheimer's disease places a substantial
emotional and financial burden on patients and their loved ones and
has a significant economic and societal impact. At J&J, we
envision a future where we can help stop the progression of AD the
moment it's detected," said Bill
Martin, Ph.D., Global Therapeutic Area Head, Neuroscience,
Johnson & Johnson Innovative Medicine. "Posdinemab has the
potential to slow the spread of tau pathology in the brain - which
may slow cognitive decline. The FDA's Fast Track designation
reflects the urgent unmet need for new treatment options for the
millions living with AD."
Posdinemab is the second Fast Track designation granted in 2024
for the Company's AD portfolio. J&J'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 Phase
2b "ReTain" trial, which is actively
enrolling, will evaluate the potential of JNJ-2056 to activate the
immune system to help generate antibodies against pathological
phosphorylated tau, with the goal of delaying or preventing onset
of symptoms, and ultimately disease progression.
Fast Track is a process designed by the FDA to expedite the
review of therapies that treat serious conditions with a high unmet
need, with the aim of getting therapies to patients earlier.
Globally, 55 million people live with dementia, with AD
accounting for 60–80 percent of cases.1 AD is a
neurodegenerative disorder marked by progressive memory loss and
other cognitive decline that disrupts daily life, leaving patients
requiring around-the-clock care and ultimately, leading to
death.
ABOUT ALZHEIMER'S DISEASE & DEMENTIA
Alzheimer's disease (AD), the most common form of dementia
worldwide, is a fatal neurodegenerative disorder characterized by
progressive memory loss and a decline in other cognitive abilities
severe enough to significantly interfere with daily
life.1 Diagnostic criteria for AD are based on
established classifications but continue to evolve as research
advances. Preclinical AD refers to individuals with detectable
Alzheimer's disease pathology (amyloid and tau) who are
cognitively unimpaired. Early Alzheimer's disease includes
individuals with mild cognitive impairment due to Alzheimer's
disease (also known as prodromal AD) and mild Alzheimer's
dementia.
As AD advances, patients experience worsening cognitive decline,
eventually losing the ability to perform basic tasks, communicate
or recognize loved ones, ultimately leading to death.1
There is no cure for AD, and despite several new advancements,
significant unmet need remains across the spectrum of this
devastating disease.
ABOUT POSDINEMAB
Posdinemab is an investigational monoclonal antibody that targets
the mid-domain of Alzheimer's disease-specific phosphorylated tau.
Posdinemab is designed to bind to pathological phosphorylated tau
when it is released from neurons and neutralize it before it can
seed/spread to another neuron. The internally-discovered compound
has shown promise in reducing tau seeding—the process by which
toxic tau spreads through the brain—in both in vitro and in vivo
non-clinical studies.
The Phase 2b "AuTonomy" study
investigating posdinemab in participants with early Alzheimer's
disease is fully enrolled and ongoing
(NCT04619420).
ABOUT JNJ-2056
JNJ-2056 (formerly known as ACI-35.030,
in collaboration with AC Immune) is an investigational anti-tau
active immunotherapy targeting the c-terminal region of
pathological phosphorylated tau. It is designed to inhibit the
seeding and spreading of pathological tau, with the goal of
delaying or preventing the onset of clinical symptoms in
preclinical Alzheimer's disease (AD).
The Phase 2b "ReTain" study is
evaluating JNJ-2056 in participants with preclinical AD who have
tau pathology in their brains but have not yet developed cognitive
impairment. The trial is actively enrolling and will be the
first active immunotherapy targeting tau tested in a preclinical AD
population (NCT06544616).
ABOUT JOHNSON & JOHNSON
At Johnson &
Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where
complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and where solutions
are personal. Through our expertise in Innovative Medicine and
MedTech, we are uniquely positioned to innovate across the full
spectrum of healthcare solutions today to deliver the breakthroughs
of tomorrow and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ or
at www.innovativemedicine.jnj.com.
Follow us at @JanssenUS and @JNJInnovMed.
Janssen Research & Development, LLC is a Johnson &
Johnson company.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of posdinemab and JNJ-2056. The reader is
cautioned not to rely on these forward-looking statements. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or known or unknown risks
or uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products, and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of healthcare
products and services; changes to applicable laws and regulations,
including global healthcare reforms; and trends toward healthcare
cost containment. A further list and descriptions of these risks,
uncertainties, and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the U.S. Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com, or
on request from Johnson & Johnson. Janssen Research &
Development, LLC nor Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments.
© Johnson & Johnson 2025. All rights reserved.
Media contact:
Allie
Prull
aprull2@its.jnj.com
Investor contact:
Lauren
Johnson
investor-relations@its.jnj.com
- Alzheimer's Association. 2024 Alzheimer's Disease Facts and
Figures. Accessed August 2024.
https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf
View original content to download
multimedia:https://www.prnewswire.com/news-releases/johnson--johnsons-posdinemab-and-tau-active-immunotherapy-receive-us-fda-fast-track-designations-for-the-treatment-of-alzheimers-disease-302345029.html
SOURCE Johnson & Johnson