8-K: INmune Bio Confirms Phase II Alzheimer's Trial is Adequately Powered After Interim Analysis

INmune Bio's Phase II Alzheimer's trial, AD02, is confirmed to be appropriately powered following a blinded interim analysis of the primary endpoint, EMACC.

Summary

• INmune Bio completed a blinded interim analysis of its Phase II Alzheimer's disease trial, AD02.
• The analysis focused on the trial's primary endpoint, the Early Mild Alzheimer's Cognitive Composite (EMACC).
• A third-party group of statisticians and neuropsychologists conducted the analysis.
• The results confirmed the accuracy of the sample size calculations and statistical power for the EMACC.
• The analysis showed no need to change the trial design or size.
• The EMACC was found to be performing as intended, with data consistent with trial planning assumptions.
• The EMACC is considered an optimal tool for detecting cognitive change in early Alzheimer's patients.
• The trial data showed low rates of missing data, indicating high acceptability of the EMACC.

Sentiment

Score: 8

Explanation: The document presents positive results from the interim analysis, confirming the trial's design and the suitability of the EMACC. The tone is optimistic and reassuring, indicating a positive outlook for the trial.

Positives

• The interim analysis confirmed the trial's design and statistical power are appropriate.
• The EMACC is performing well and is suitable for measuring cognitive change in early Alzheimer's.
• The trial data is of high quality with low rates of missing data.
• The EMACC is an objective measure of cognitive function, unlike some other cognitive tests.
• The EMACC has been successfully used in other studies, including by Biogen.

Risks

• Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved.
• The company's ability to produce more drug for clinical trials is a risk.
• The availability of substantial additional funding is a risk to the company's operations.
• There is no guarantee that the company's products will be approved by the FDA or any regulatory body.

Future Outlook

The company will continue with the clinical trials for XPro and INKmune, but there is no assurance of specific outcomes or regulatory approvals.

Management Comments

• CJ Barnum, PhD, VP of Neuroscience at INmune Bio, stated that the interim analysis was critical to ensure the EMACC is performing as intended.
• Paul Maruff PhD, a senior consultant on the AD02 program, said it is refreshing to work with a company that uses a data-driven approach to cognitive testing.
• Dr. Judith Jeager PhD, the neuropsychologist that worked closely with INmune Bio, stated that the EMACC is the optimal tool for detecting cognitive change in inflamed patients with early AD.

Industry Context

The announcement highlights the importance of using appropriate cognitive tests for different mechanisms of action in Alzheimer's treatments, contrasting the approach of targeting inflammation with anti-amyloid therapies. This is relevant as the industry is exploring various approaches to treating Alzheimer's beyond amyloid reduction.

Comparison to Industry Standards

• The document references Biogen's use of the EMACC in their Tango Study of the gosenuremab program (BIIB092), indicating a benchmark for the EMACC's application in clinical trials.
• The document mentions that the EMACC is more objective than other cognitive tests like CDR-SB and ADAS-Cog, suggesting a higher standard for cognitive measurement in early AD trials.
• The document highlights the EMACC's association with biological markers of inflammation in the Alzheimer's Disease Neuroimaging Initiative (ADNI) study, indicating a strong correlation with relevant disease markers.

Stakeholder Impact

• The positive results of the interim analysis are likely to be viewed favorably by shareholders.
• The confirmation of the trial's design and the suitability of the EMACC may increase confidence in the company's approach to treating Alzheimer's.
• The potential success of the trial could lead to new treatment options for patients with early Alzheimer's.

Next Steps

• The company will continue with the Phase II clinical trial for AD02.
• The company will continue with clinical trials for XPro and INKmune.

Key Dates

Keywords

Alzheimer's disease, clinical trial, EMACC, cognitive function, neuroinflammation, XPro, interim analysis, INmune Bio, neuropsychology, innate immune system