8-K: INmune Bio's Alzheimer's Trial Shows Strong Correlation Between Novel Cognitive Measure and Standard Endpoint

INmune Bio announced that additional analysis of its Phase II Alzheimer's trial data demonstrated a strong correlation between its novel cognitive measure, EMACC, and the standard clinical endpoint, CDR-SB.

Summary

• INmune Bio has released results from an additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease trial.
• The analysis focused on the performance of a novel cognitive measure called EMACC.
• The results showed a highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), which is the accepted endpoint for Alzheimer's trials.
• The correlation between EMACC scores at baseline and CDR-SB was statistically significant with a p-value of less than 0.001.
• EMACC also showed high reliability, with a correlation of 0.93 when measured during screening and at the first study visit.
• The difference in EMACC performance between patients with prodromal AD (CDR global rating of 0.5) and mild dementia (CDR global rating of 1.0) was large, with an effect size of 0.87 (p<0.0001).
• The company expects to complete enrollment in the trial near the end of the current quarter and announce topline data approximately six months after the last patient is enrolled.

Sentiment

Score: 8

Explanation: The document presents very positive results from the analysis of the EMACC measure, with strong statistical significance and high reliability. The management commentary is also positive, and the company is moving forward with the trial. However, there are still risks associated with clinical trials and funding.

Positives

• The EMACC measure shows a strong correlation with the standard CDR-SB endpoint, validating its use in Alzheimer's trials.
• EMACC demonstrates high reliability and precision in measuring cognitive changes.
• The study design using EMACC as the primary endpoint is considered less risky than traditional designs.
• EMACC is able to differentiate between different stages of Alzheimer's disease effectively.
• The results support the decision to use EMACC as the primary endpoint in the AD02 trial.

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 for the company to continue operations is a risk.
• There is no guarantee that the company's products will be approved by the FDA or any regulatory body.

Future Outlook

The company looks forward to completing enrollment near the end of the current quarter and to announcing topline data approximately six months from the last patient enrolled. The company is also continuing to develop other product platforms.

Management Comments

• Judith Jaeger, Ph.D., stated that the analysis validates the selection of the cognitive endpoints measured in the AD02 trial.
• C.J. Barnum, Ph.D., stated that the novel design elements used in the AD02 Phase 2 trial significantly de-risk the clinical program compared to traditional trial designs.

Industry Context

The announcement is significant as it highlights the potential of a novel cognitive measure, EMACC, to improve the efficiency and accuracy of Alzheimer's clinical trials. The use of EMACC, which is empirically derived and more objective than traditional measures, could lead to more reliable results and faster drug development in the field of Alzheimer's research.

Comparison to Industry Standards

• The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is the most used clinical rating scale in AD registration studies, making the correlation with EMACC highly relevant.
• The development of EMACC by Judith Jaeger, a prominent neurocognition expert, adds credibility to the measure.
• Biogen's previous reporting of EMACC's performance characteristics in early AD at CTAD in 2021 provides a benchmark for comparison.
• The use of a novel cognitive measure like EMACC is a departure from traditional methods, potentially offering a more precise and reliable approach to assessing cognitive change in early AD patients.

Stakeholder Impact

• Shareholders may view the positive results as a positive sign for the company's clinical program.
• Patients with Alzheimer's disease may benefit from the development of more effective treatments.
• The scientific community may find the results of the EMACC measure to be valuable for future research.

Next Steps

• The company will complete enrollment in the AD02 Phase 2 trial near the end of the current quarter.
• Topline data from the trial is expected approximately six months after the last patient is enrolled.

Key Dates

Keywords

Alzheimer's Disease, EMACC, CDR-SB, Cognitive Measure, Clinical Trial, Neuroinflammation, INmune Bio, Phase II Trial, Biomarkers, Neuropsychology