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Also known as XENP1595, DN-TNF
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...
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XPro1595 is an investigational small molecule developed by INmune Bio Inc. (ticker INMB) for Alzheimer disease. It is a Phase 2 candidate that has been studied in biomarker-selected patients with early Alzheimer disease and evidence of inflammation. It has received FDA Fast Track designation.
XPro1595 is being developed for Alzheimer disease, specifically in patients selected for biomarkers of inflammation. Clinical testing has focused on early Alzheimer disease and related conditions including mild cognitive impairment. It is investigational and has not been approved for any indication.
XPro1595 targets TNF, a cytokine involved in inflammatory signaling. By acting on this cytokine target, the small molecule is designed to address neuroinflammation, which is the rationale for testing it in biomarker-selected Alzheimer disease patients.
XPro1595 is being developed by INmune Bio Inc., which trades under the ticker INMB. The company is the sponsor of the clinical program evaluating the drug in Alzheimer disease.
XPro1595 is in Phase 2 development. Two completed trials have evaluated it: a Phase 2 study in early Alzheimer disease with biomarkers of inflammation and an earlier Phase 1 biomarker-directed study. It is investigational and has not been approved by the FDA.
XPro1595 has been studied in two completed trials. NCT05318976 was a Phase 2 trial in early Alzheimer disease with biomarkers of inflammation that enrolled 207 patients across eight countries. NCT03943264 was a Phase 1 biomarker-directed study in Alzheimer disease that enrolled 20 patients in Australia.