INmune Bio Inc. Announces New Phase 1 Study Data Demonstrating Dose-Dependent Effect of XPro™ on Proteins that Regulation Synapses in Alzheimer’s Patients
INmune Bio (NASDAQ: INMB) presented new Phase 1 study data at the Alzheimer's Association International Conference, demonstrating XPro's™ dose-dependent effect on synaptic proteins in Alzheimer's patients. The 12-week treatment resulted in significant changes to proteins essential for neuron communication. This aligns with preclinical models and supports the restoration of normal immune function.
The company's VP of Neuroscience, CJ Barnum, emphasized the importance of these findings, as synaptic loss is an early and devastating consequence of Alzheimer's. CEO RJ Tesi highlighted that this cellular-level evidence supports recent EEG data showing improved synaptic function. INmune Bio is currently conducting a Phase 2 trial for mild to moderate Alzheimer's, with top-line results expected in early 2025.
INmune Bio (NASDAQ: INMB) ha presentato nuovi dati dello studio di Fase 1 alla Conferenza Internazionale dell'Associazione Alzheimer, dimostrando l'effetto dose-dipendente di XPro™ sulle proteine sinaptiche nei pazienti affetti da Alzheimer. Il trattamento di 12 settimane ha portato a cambiamenti significativi nelle proteine essenziali per la comunicazione neuronale. Questo è in linea con i modelli preclinici e sostiene il ripristino della normale funzione immunitaria.
Il VP Neuroscienze dell'azienda, CJ Barnum, ha sottolineato l'importanza di questi risultati, poiché la perdita sinaptica è una conseguenza precoce e devastante dell'Alzheimer. Il CEO RJ Tesi ha evidenziato che queste evidenze a livello cellulare supportano i recenti dati EEG che mostrano un miglioramento della funzione sinaptica. INmune Bio sta attualmente conducendo una prova di Fase 2 per l'Alzheimer da lieve a moderato, con risultati principali attesi all'inizio del 2025.
INmune Bio (NASDAQ: INMB) presentó nuevos datos del estudio de Fase 1 en la Conferencia Internacional de la Asociación de Alzheimer, demostrando el efecto dependiente de la dosis de XPro™ en proteínas sinápticas en pacientes con Alzheimer. El tratamiento de 12 semanas resultó en cambios significativos en proteínas esenciales para la comunicación neuronal. Esto se alinea con modelos preclínicos y apoya la restauración de la función inmune normal.
El VP de Neurociencia de la empresa, CJ Barnum, enfatizó la importancia de estos hallazgos, ya que la pérdida sináptica es una consecuencia temprana y devastadora del Alzheimer. El CEO RJ Tesi destacó que esta evidencia a nivel celular apoya los datos recientes de EEG que muestran una función sináptica mejorada. INmune Bio está llevando a cabo actualmente un ensayo de Fase 2 para el Alzheimer leve a moderado, con resultados clave esperados a principios de 2025.
INmune Bio (NASDAQ: INMB)는 알츠하이머 협회 국제 회의에서 1상 연구 데이터의 새로운 결과를 발표하며 알츠하이머 환자에서 XPro™의 용량 의존적 효과가 시냅스 단백질에 미친 영향을 보여주었습니다. 12주 치료 결과 신경 세포 간의 소통에 필수적인 단백질에 중요한 변화가 있었습니다. 이는 전임상 모델과 일치하며 정상 면역 기능의 회복을 뒷받침합니다.
회사의 신경 과학 담당 VP인 CJ Barnum은 이러한 발견의 중요성을 강조하며 시냅스 손실이 알츠하이머의 조기이자 파괴적인 결과임을 언급했습니다. CEO RJ Tesi는 이러한 세포 수준의 증거가 개선된 시냅스 기능을 보여주는 최근 EEG 데이터와 일치한다고 강조했습니다. INmune Bio는 현재 경미한에서 중간 정도의 알츠하이머에 대한 2상 시험을 진행 중이며 주요 결과는 2025년 초에 예상됩니다.
INmune Bio (NASDAQ: INMB) a présenté de nouvelles données d'étude de Phase 1 lors de la Conférence Internationale de l'Association Alzheimer, démontrant l'effet dose-dépendant de XPro™ sur les protéines synaptiques chez les patients atteints d'Alzheimer. Le traitement de 12 semaines a entraîné des changements significatifs dans les protéines essentielles à la communication neuronale. Cela est conforme aux modèles précliniques et soutient la restauration de la fonction immunitaire normale.
Le VP des neurosciences de l'entreprise, CJ Barnum, a souligné l'importance de ces résultats, car la perte synaptique est une conséquence précoce et dévastatrice de la maladie d'Alzheimer. Le PDG RJ Tesi a souligné que ces preuves au niveau cellulaire soutiennent les données d'EEG récentes montrant une fonction synaptique améliorée. INmune Bio mène actuellement un essai de Phase 2 pour l'Alzheimer léger à modéré, avec des résultats principaux attendus au début de 2025.
INmune Bio (NASDAQ: INMB) hat auf der Internationalen Alzheimer-Konferenz neue Daten aus der Phase-1-Studie präsentiert, die den dosisabhängigen Effekt von XPro™ auf synaptische Proteine bei Alzheimer-Patienten demonstrieren. Die 12-wöchige Behandlung führte zu signifikanten Veränderungen bei Proteinen, die für die neuronale Kommunikation entscheidend sind. Dies stimmt mit präklinischen Modellen überein und unterstützt die Wiederherstellung der normalen Immunfunktion.
Der VP für Neurowissenschaften des Unternehmens, CJ Barnum, betonte die Bedeutung dieser Erkenntnisse, da der synaptische Verlust eine frühe und verheerende Folge von Alzheimer ist. CEO RJ Tesi hob hervor, dass diese zellulären Beweise die kürzlichen EEG-Daten unterstützen, die eine verbesserte synaptische Funktion zeigen. INmune Bio führt derzeit eine Phase-2-Studie für leicht bis mäßig ausgeprägtes Alzheimer durch, deren Ergebnisse für Anfang 2025 erwartet werden.
- XPro™ demonstrated significant effects on synaptic proteins in Alzheimer's patients
- Treatment aligns with preclinical models and supports restoration of normal immune function
- Evidence of treatment effect at cellular level in proteins affected by Alzheimer's pathologies
- Phase 2 trial for mild to moderate Alzheimer's ongoing with results expected in early 2025
- None.
The new data from INmune Bio's Phase 1 study of XPro™ in Alzheimer's disease (AD) patients is highly significant for several reasons:
- It demonstrates a dose-dependent effect on synaptic proteins, which are important for neuronal communication and cognitive function.
- The results show XPro™'s impact on a broad range of proteins and pathways involved in synapse regulation, suggesting a comprehensive approach to addressing AD pathology.
- This data provides a mechanistic link between XPro™'s known anti-inflammatory effects and potential cognitive benefits in AD patients.
The observed changes in the cerebrospinal fluid proteome after just 12 weeks of treatment are particularly encouraging. This rapid effect on synaptic proteins could translate to faster clinical improvements compared to other AD therapies, which often take months or years to show benefits.
However, it's important to note that while these results are promising, they are still from a Phase 1 study. The ongoing Phase 2 trial will be important in determining whether these biological changes translate to measurable cognitive improvements in patients with mild to moderate AD.
Overall, this data strengthens the scientific rationale behind XPro™ and positions INmune Bio as a potential leader in the development of immune-modulating therapies for neurodegenerative diseases.
The new Phase 1 data for XPro™ presents a positive outlook for INmune Bio (NASDAQ: INMB) and its investors:
- The results provide strong biological evidence supporting XPro™'s mechanism of action, potentially de-risking the ongoing Phase 2 trial.
- This data could attract increased interest from institutional investors and potential partners in the pharmaceutical industry, potentially leading to collaborations or licensing deals.
- If XPro™ continues to show promise, it could position INmune Bio as a significant player in the lucrative Alzheimer's disease market, estimated to be worth over
$12 billion annually by 2028.
However, investors should consider several factors:
- The company's cash position and burn rate will be critical, as late-stage clinical trials in AD are expensive and time-consuming.
- While the Phase 1 data is encouraging, the Phase 2 results expected in early 2025 will be the true test of XPro™'s potential.
- The AD drug development landscape is highly competitive, with several large pharmaceutical companies also pursuing novel therapies.
In the short term, this news may lead to increased investor interest and potential stock price appreciation. Long-term value will depend on the success of the Phase 2 trial and the company's ability to advance XPro™ through late-stage development and potential commercialization.
AAIC Poster Presentation Highlights XPro's™ Significant Effects on a Wide Range of Synaptic Proteins and Pathways
BOCA RATON, Fla., July 29, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease is pleased to be presenting results of a new and advanced proteomic analysis at this year’s annual Alzheimer’s Association International Conference (AAIC) in Philadelphia, PA. The poster summarizes dose-related changes in the cerebrospinal fluid (CSF) proteome in patients with Alzheimer’s disease (AD) treated with XProTM in the company’s phase 1b study.
| Monday, July 29 | Poster #95343 | Dose-related modulation of the synaptic proteome after short-term treatment with XPro1595 for Alzheimer's disease |
The new analysis revealed that a 12-week treatment with XPro™ resulted in a significant change in synaptic proteins, which are essential for communication between neurons.
“The loss of synapses begins early in Alzheimer’s disease and has devastating consequences as the disease progresses,” stated CJ Barnum, PhD, VP of Neuroscience at INmune Bio. “The robust effect of XProTM on a broad number of proteins and pathways that regulate the formation of synapses is consistent with what we have observed in preclinical models and what we expect to happen when normal/healthy immune function is restored.”
The formation and elimination of synapses is executed by cells of the innate immune system such as astrocytes. When these cells are in a dysregulated inflammatory/immune state, synapse formation is reduced and synapse elimination is increased, resulting in loss of communication between neurons which, in the case of AD, results in cognitive impairment. Restoring synapses requires a normally functioning innate immune system.
“We are encouraged by this new evidence of a treatment effect at the cellular level in proteins known to be affected by AD pathologies,” said Company CEO RJ Tesi, MD. “XPro’s direct impact on synaptic proteins provides further support to the improvement in synaptic function we recently observed with EEG data and provides further evidence that we are having a significant effect on restoring the immune system. This is yet another biological precursor to what we believe will result in a cognitive benefit which we are currently testing in our ongoing Phase 2 trial.”
INmune Bio is currently running a phase 2 clinical trial in mild to moderate Alzheimer’s patients. Top-line results from that trial are expected in early 2025.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation without immunosuppression. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation and immunology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.
Forward-Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contact:
David Moss
Chief Financial Officer
(858) 964-3720
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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