INmune Bio, Inc. Completes Blinded Interim Analysis of Phase II Alzheimer’s Disease Trial
INmune Bio (NASDAQ: INMB) has completed a blinded interim analysis of its Phase II Alzheimer’s Disease (AD) trial, AD02. The trial uses the Early Mild Alzheimer’s Cognitive Composite (EMACC) as its primary endpoint. The analysis, conducted by third-party statisticians and neuropsychologists, confirmed the trial’s design, operational execution, and data management are of high quality. The interim results showed no need to change the trial design or sample size, reinforcing the EMACC's suitability in measuring cognitive changes in early AD. EMACC was chosen for its objective and validated cognitive measures, previously demonstrated in Biogen studies, and its strong association with biological markers of inflammation. Dr. CJ Barnum, VP of Neuroscience, endorsed the positive findings, along with consultants Dr. Paul Maruff and Dr. Judith Jaeger, citing the EMACC’s high acceptability and reliability in detecting cognitive changes in patients with early AD.
- The interim analysis confirmed no need to alter the trial design or sample size, indicating robust initial planning.
- The trial's operational execution, data collection, and management are high quality, as validated by third-party evaluators.
- EMACC was found suitable for detecting cognitive changes and strongly associated with biological markers of inflammation.
- Low rates of missing data indicate high acceptability of EMACC in the symptomatic AD sample.
- Estimates of group means and standard deviations were consistent with trial planning assumptions.
- None.
The interim analysis of INmune Bio’s Phase II Alzheimer’s Disease trial is a notable milestone. From a clinical trial design perspective, confirming the sample size calculations and statistical power using the Early Mild Alzheimer’s Cognitive Composite (EMACC) is significant. This ensures that the trial is well-positioned to detect meaningful differences between the treatment and control groups if they exist.
EMACC’s validation as an endpoint in this context is a critical aspect. The use of an objective measurement tool, designed to capture cognitive changes in early Alzheimer’s, aligns well with the need for precision in detecting subtle cognitive declines. The low rates of missing data indicate robust data collection and participant compliance, which are key for the integrity of trial outcomes.
Moreover, the interim analysis' confirmation of consistent estimates with prior assumptions reinforces the trial's methodological rigor. This gives confidence that the trial is appropriately designed to meet its primary objectives, reducing the risk of underpowered results which can lead to inconclusive outcomes.
From a financial perspective, the completion of a successful interim analysis can be viewed favorably. This event can increase investor confidence as it indicates that the trial is proceeding according to plan without unexpected issues necessitating changes in design or sample size, which could be costly or delay timelines.
Additionally, the company’s approach of using a validated, objective measure like EMACC and having it confirmed by a third party, underscores a commitment to rigorous scientific methodology. This can be particularly reassuring for investors who are wary of the high risks associated with clinical trials, especially in the challenging field of Alzheimer’s research.
In the short term, this can lead to a positive sentiment and potential stock price appreciation due to reduced uncertainty. In the long term, demonstrating progress and adherence to clinical and regulatory expectations is essential for maintaining investor trust and facilitating further funding rounds or partnerships.
Considering market implications, the use of EMACC, particularly its emphasis on targeting inflammation rather than amyloid burden, differentiates INmune Bio from other companies in the Alzheimer’s space. This could position the company as a leader in a potentially underexplored therapeutic pathway.
The data-driven approach noted by experts in the analysis speaks volumes in a market often fraught with high-profile trial failures. Investors could see this as a strategic advantage, positioning INmune Bio’s candidate as a novel and potentially more effective treatment option.
The absence of floor and ceiling effects and the high acceptability of the test among participants, are promising. They suggest that the EMACC can reliably detect cognitive changes, bolstering the credibility of any positive trial outcomes.
The planned interim analysis confirms the accuracy of the sample size calculations and statistical power for EMACC, the primary endpoint.
The interim analysis, performed by a third-party, demonstrated no need to change trial design or size.
BOCA RATON, Fla., June 27, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today confirmed the Phase II Alzheimer’s Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial’s primary endpoint, the Early Mild Alzheimer’s Cognitive Composite (EMACC). The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality.
INmune Bio commissioned a third-party group of statisticians and neuropsychologists to evaluate the interim data of patients who completed the 6-month trial. The main goal of the blinded analysis was to evaluate the power and performance characteristics of the primary endpoint, the EMACC.
The EMACC is an empirically validated cognitive measure composed of standardized and widely used neuropsychological tests that are ideally suited for use in clinical trials in Early Alzheimer’s Disease (AD). Compared to CDR-SB and ADAS-Cog for example, the EMACC is an objective measure of cognitive function that accurately captures cognitive changes that occur during early AD. The performance characteristics of the EMACC in early AD were first reported by Biogen at CTAD in 2021 (LBR05) where it was successfully applied to measure cognitive decline in the Biogen Tango Study of the gosenuremab program (BIIB092). Notably, EMACC was also found to be strongly associated with biological markers of inflammation in the Alzheimer’s Diesase Neuroimaging Initiative (ADNI) AD study; which was used to compute the statistical power for AD02.
“As this is the first trial to feature the EMACC as a primary endpoint, this interim analysis by a third party was critical to ensure that the EMACC is performing as intended,” says CJ Barnum, PhD, VP of Neuroscience at INmune Bio. “The results presented to the Company from this blinded analysis were extremely encouraging.”
“As a neuropsychologist that has worked in industry for more than three decades, it is refreshing to work with a company that uses a data driven approach to cognitive testing,” said Paul Maruff PhD, a senior consultant on the AD02 program. “Unlike the anti-amyloid therapies, XPro™ targets inflammation, a completely different mechanism. We should not expect that the same cognitive test will work for all mechanisms. INmune Bio’s approach optimizes the measurement of cognition for a therapy that targets inflammation. As part of a scientific committee reviewing data from the first interim analyses, I was reassured to see the very low rates of missing data in the study, which indicate that the EMACC has high acceptability in the symptomatic AD sample enrolled to date. Furthermore, estimates of group means and standard deviations, computed on the blinded data from AD02, showed these estimates to be consistent with those used for planning the trial, confirming that assumptions made during planning are being met in the conduct of the trial itself.”
Dr. Judith Jeager PhD, the neuropsychologist that worked closely with INmune Bio to identify the most appropriate cognitive test to evaluate XPro™ was similarly pleased with the result of the interim analysis: “We believe the EMACC is the optimal tool for detecting cognitive change and differentiating an effective drug from placebo in inflamed patients with early AD. This interim analysis confirmed once again its excellent suitability for this population as indicated by normally distributed data, paucity of outliers and absence of floor and ceiling effects. The blinded review of EMACC’s critical psychometric parameters exceed my expectations and reinforces that the EMACC is the appropriate test to measure cognition in INmune Bio’s AD02 clinical trial.”
About the Expert Consultants
Paul Maruff, PhD, is the Chief Innovation Officer of Cogstate, a global leader in supporting clinical trials that use cognition as a clinical endpoint. He is recognized as a leader in testing of cognition in clinical trials with more than 30 years of experience.
Judith Jaeger, PhD, is the principal developer of the EMACC. Judith Jaeger PhD is founder of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades’ experience.
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. 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 biotechnology 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, CFO (858) 964-3720
info@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
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