Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease
Johnson & Johnson (NYSE: JNJ) has received FDA Fast Track designations for two Alzheimer's disease treatments: posdinemab and JNJ-2056. Posdinemab, a phosphorylated tau-directed monoclonal antibody, is being investigated in the Phase 2b 'AuTonomy' study for early Alzheimer's disease treatment. The antibody has demonstrated potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated AD patients.
JNJ-2056, the first active immunotherapy targeting tau in a preclinical AD population, received its Fast Track designation in July 2024. It is currently being evaluated in the Phase 2b 'ReTain' trial to assess its potential in generating antibodies against pathological phosphorylated tau, aiming to delay or prevent symptom onset.
These developments are significant as Alzheimer's disease affects approximately 55 million people globally, accounting for 60-80% of dementia cases.
Johnson & Johnson (NYSE: JNJ) ha ricevuto le designazioni Fast Track dalla FDA per due trattamenti per l'Alzheimer: posdinemab e JNJ-2056. Posdinemab, un anticorpo monoclonale diretto contro la tau fosforilata, è attualmente in fase di studio nella sperimentazione di fase 2b 'AuTonomy' per il trattamento precoce della malattia di Alzheimer. L'anticorpo ha dimostrato un potenziale nel mirare alla tau fosforilata associata alla malattia nel liquido cerebrospinale di pazienti con AD trattati.
JNJ-2056, la prima immunoterapia attiva mirata alla tau in una popolazione con AD preclinica, ha ricevuto la sua designazione Fast Track nel luglio 2024. Attualmente è in fase di valutazione nella sperimentazione di fase 2b 'ReTain' per valutare il suo potenziale nella generazione di anticorpi contro la tau fosforilata patologica, con l'obiettivo di ritardare o prevenire l'insorgenza dei sintomi.
Questi sviluppi sono significativi poiché la malattia di Alzheimer colpisce circa 55 milioni di persone in tutto il mondo, rappresentando il 60-80% dei casi di demenza.
Johnson & Johnson (NYSE: JNJ) ha recibido designaciones de Fast Track por parte de la FDA para dos tratamientos de la enfermedad de Alzheimer: posdinemab y JNJ-2056. El posdinemab, un anticuerpo monoclonal dirigido contra la tau fosforilada, está siendo investigado en el estudio de fase 2b 'AuTonomy' para el tratamiento temprano de la enfermedad de Alzheimer. Este anticuerpo ha demostrado potencial para dirigirse a la tau fosforilada asociada a la enfermedad en el líquido cefalorraquídeo de pacientes con AD tratados.
JNJ-2056, la primera inmunoterapia activa dirigida a la tau en una población de AD preclínica, recibió su designación de Fast Track en julio de 2024. Actualmente se está evaluando en el ensayo de fase 2b 'ReTain' para evaluar su potencial en la generación de anticuerpos contra la tau fosforilada patológica, con el objetivo de retrasar o prevenir la aparición de síntomas.
Estos desarrollos son significativos, ya que la enfermedad de Alzheimer afecta a aproximadamente 55 millones de personas en todo el mundo, representando el 60-80% de los casos de demencia.
존슨앤존슨 (NYSE: JNJ)는 두 가지 알츠하이머 병 치료제 포스디네맙과 JNJ-2056에 대해 FDA의 패스트트랙 지정을 받았습니다. 포스디네맙은 인산화된 타우를 표적으로 하는 단클론 항체로, 초기 알츠하이머 치료를 위한 2b 단계 'AuTonomy' 연구에서 조사되고 있습니다. 이 항체는 치료 받은 알츠하이머 환자의 뇌척수액에서 질병 관련 인산화된 타우를 표적하는 데 잠재력을 보여주었습니다.
JNJ-2056은 전임상 알츠하이머 집단을 대상으로 하는 첫 번째 능동 면역 요법으로, 2024년 7월에 패스트트랙 지정을 받았습니다. 현재는 병리학적 인산화 타우에 대한 항체 생성 가능성을 평가하기 위해 2b 단계 'ReTain' 시험에서 평가되고 있으며, 증상 발생을 지연시키거나 예방하는 것을 목표로 하고 있습니다.
이러한 개발은 알츠하이머 병이 전 세계 약 5,500만 명에게 영향을 미치며, 이는 치매 사례의 60-80%를 차지하기 때문에 중요합니다.
Johnson & Johnson (NYSE: JNJ) a reçu des désignations Fast Track de la FDA pour deux traitements de la maladie d'Alzheimer : posdinemab et JNJ-2056. Le posdinemab, un anticorps monoclonal dirigé contre la tau phosphorylée, est en cours d'étude dans l'essai de phase 2b 'AuTonomy' pour le traitement précoce de la maladie d'Alzheimer. Cet anticorps a montré un potentiel pour cibler la tau phosphorylée associée à la maladie dans le liquide céphalorachidien de patients traités pour l'AD.
JNJ-2056, la première immunothérapie active ciblant la tau dans une population AD préclinique, a reçu sa désignation Fast Track en juillet 2024. Il est actuellement évalué dans l'essai de phase 2b 'ReTain' pour évaluer son potentiel à générer des anticorps contre la tau phosphorylée pathologique, dans le but de retarder ou de prévenir l'apparition des symptômes.
Ces développements sont significatifs car la maladie d'Alzheimer touche environ 55 millions de personnes dans le monde, représentant 60 à 80 % des cas de démence.
Johnson & Johnson (NYSE: JNJ) hat von der FDA Fast-Track-Designationen für zwei Behandlungen der Alzheimer-Krankheit erhalten: posdinemab und JNJ-2056. Posdinemab, ein phosphoryliertes Tau-gerechtes monoklonales Antikörper, wird in der Phase 2b-Studie 'AuTonomy' zur Behandlung der frühen Alzheimer-Krankheit untersucht. Der Antikörper hat das Potenzial gezeigt, phosphoryliertes Tau im Liquor cerebrospinalis bei behandelten AD-Patienten zu targetieren.
JNJ-2056, die erste aktive Immuntherapie, die auf Tau in einer präklinischen AD-Population abzielt, erhielt seine Fast-Track-Designierung im Juli 2024. Es wird derzeit in der Phase 2b-Studie 'ReTain' bewertet, um sein Potenzial zur Erzeugung von Antikörpern gegen pathologisches phosphoryliertes Tau zu untersuchen, mit dem Ziel, den Symptombeginn zu verzögern oder zu verhindern.
Diese Entwicklungen sind bedeutend, da die Alzheimer-Krankheit weltweit etwa 55 Millionen Menschen betrifft und 60-80% der Demenzfälle ausmacht.
- FDA Fast Track designation received for two Alzheimer's treatments
- Positive preliminary results showing posdinemab's effectiveness in targeting tau in cerebrospinal fluid
- Active enrollment in Phase 2b trials for both treatments
- None.
Insights
The dual Fast Track designations for J&J's tau-targeting therapies represent a pivotal advancement in Alzheimer's treatment landscape. Posdinemab, as a phosphorylated tau-directed monoclonal antibody, targets a important mechanism in AD progression - the spread of toxic tau proteins. The Phase 2b "AuTonomy" study's focus on early AD patients is particularly strategic, as intervening before extensive neurodegeneration occurs typically yields better outcomes.
The second candidate, JNJ-2056, employs an innovative active immunotherapy approach in preclinical AD populations. This preventive strategy could be groundbreaking - by stimulating the immune system to generate antibodies against pathological tau before symptom onset, it may effectively delay or prevent disease progression. This dual-pronged approach, targeting both symptomatic and pre-symptomatic populations, demonstrates sophisticated pipeline diversification.
For context, successful tau-targeting therapies could address limitations of current amyloid-based treatments, potentially offering better efficacy and broader patient applicability. The market opportunity is substantial, considering AD affects 33-44 million people globally.
These Fast Track designations significantly enhance J&J's competitive position in the lucrative Alzheimer's market, estimated to reach
The dual-program strategy minimizes development risk while maximizing market potential - targeting both early-stage patients (posdinemab) and pre-symptomatic individuals (JNJ-2056) could capture different market segments. If successful, these programs could generate peak annual sales of
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
"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
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- Alzheimer's Association. 2024 Alzheimer's Disease Facts and Figures. Accessed August 2024. https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf
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