Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XPro1595 · 2 trials · 10 indications
Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency \[D-KEFS\]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement.
Adverse events will be assessed by clinical and laboratory measures
Adverse events will be assessed by clinical and laboratory measures
| Arm | Type | Description |
|---|---|---|
| 1.0 mg/kg XPro1595 | EXPERIMENTAL | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. |
| 1.0 mg/kg Placebo | PLACEBO_COMPARATOR | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. |
| 0.3 mg/kg XPro1595 | EXPERIMENTAL | 0.3 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| 0.6 mg/kg XPro1595 | EXPERIMENTAL | 0.6 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| XPro1595 | DRUG | XPro1595 will be delivered by subcutaneous injection once a week |
| Placebo | DRUG | Placebo will be delivered by subcutaneous injection once a week |
The screening window for this trial is 45 days. Inclusion Criteria: To be eligible for study entry, patients must satisfy all of the following criteria: * Adult patients 50 years to ≤ 85 years of age at the time of consent; * Meets the diagnostic criteria of MCI of probable Alzheimer's disease (J...
Top 20 of 24 competitors
XPro1595 is an investigational small molecule being studied for the treatment of Alzheimer Disease. It is being developed by INmune Bio Inc. (INMB) and has received Fast Track designation from the FDA. The drug is currently in Phase 2 clinical development, though both completed trials were for Alzheimer's patients.
XPro1595 is a small molecule designed to target inflammation in Alzheimer's disease. It is being studied specifically in patients with biomarkers of inflammation, as seen in the Phase 2 trial NCT05318976, which enrolled early Alzheimer's patients with inflammatory biomarkers.
XPro1595 is being developed by INmune Bio Inc., a biopharmaceutical company traded on the NASDAQ under the ticker INMB. The company is conducting clinical trials of XPro1595 for Alzheimer Disease.
XPro1595 is in Phase 2 clinical development for Alzheimer Disease. The drug has completed two clinical trials, including a Phase 1 study and a Phase 2 study, and has received Fast Track designation from the FDA. It remains investigational and is not yet approved.
XPro1595 has completed two clinical trials: NCT03943264, a Phase 1 biomarker-directed study in 20 Alzheimer's patients in Australia, and NCT05318976, a Phase 2 study in 207 early Alzheimer's patients with biomarkers of inflammation across multiple countries. Both trials are completed.
XPro1595 is the sole name provided for this investigational drug. It is being studied under this name in clinical trials for Alzheimer Disease, and no alternative names have been associated with it in the available data.