BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05318976 (XPro1595 in Early Alzheimer's Disease With Biomarkers of…): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial partial success for this trial. The 30 Jun 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05318976
Acronym
MINDFuL
Drug Name
XPro1595
Drug MoA
biologic soluble TNFalpha neutralizer
Drug Modality
recombinant protein biologic
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Early Alzheimer's Disease With Biomarkers of Inflammation
Human Patients
208
Sponsor
Inmune Bio
Phase
Phase 2

Prediction of , index 1300

Prospective Prediction
Prediction Index
1300
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in CDR/ADCS-ADL at most numerically superior to lecanemab for neuroinflammation-biomarker-stratified mild AD patients)
Technical Prediction
partial SUCCESS (statistically maybe significant yet moderate clinical benefit in EMACC for neuroinflammation-biomarker-stratified mild AD patients)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
313 days in advance
Readout Data Interpretation
XPro1595 did not meet the primary cognitive endpoint EMACC in the mITT population; yet a clinical benefit in EMACC (effect size 0.27) is observed for early Alzheimer’s patients with two or more biomarkers of inflammation at baseline
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
Phase
Phase 2
Status
Completed
Enrollment
207
Lead sponsor
Inmune Bio, Inc.
Conditions
Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Mild Cognitive Impairment
Interventions
DRUG: XPro1595; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-02-28
Primary completion
2025-05-12
Completion
2025-05-12
Results first posted
2026-06-29
Primary outcomes
  • Change in Early and Mild Alzheimer's Cognitive Composite (EMACC) (24 Weeks)

NCT05318976 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials