Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Latozinemab
AL001 · 2 trials · 2 indications
Number of TEAEs categorized by severity
Number of treatment-related TEAEs categorized by severity
Number of TEAEs leading to study drug discontinuation
Titer values of antidrug antibodies (ADAs) in participants receiving latozinemab at week 97/Part 1 end of study
Presence of confirmatory antidrug antibodies (ADAs) in participants who test positive for ADA at week 97 (Part 1 End of Study).
The Sheehan Suicidality Tracking Scale (S-STS) is a structured assessment tool used to evaluate the presence, severity, and frequency of suicidal ideation and behavior. It includes items that address passive thoughts of death, active suicidal ideation, intent, planning, suicide attempts, and non-suicidal self-injury. The S-STS total score ranges from 0 to 64, based on 16 items each rated from 0 (not at all) to 4 (extremely), with higher scores indicating greater severity of suicidal ideation, intent, or behavior. The total score provides a quantitative measure of suicidality severity and is sensitive to change over time, making it suitable for clinical monitoring and research use.
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
| Arm | Type | Description |
|---|---|---|
| Granulin and C9orf72 | EXPERIMENTAL | IV administration of AL001; 60 mg/kg, every 4 weeks \[q4w\] |
| AL001 | EXPERIMENTAL | Up to six single ascending doses of AL001 |
| Saline Solution | PLACEBO_COMPARATOR | Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects |
| Name | Type | Description |
|---|---|---|
| AL001 | DRUG | 60 mg/kg of AL001 every 4 weeks |
| Placebo | OTHER | Saline solution administered as a single infusion as palcebo. |
Inclusion Criteria: * At screening, female participants must be nonpregnant and nonlactating * In good physical health on the basis of no clinically significant findings from medical history, physical examinations (PEs), laboratory tests, ECGs, and vital signs. * Participant is a carrier of a loss ...
AL001 is an investigational monoclonal antibody developed by Alector, Inc. for frontotemporal dementia. It is designed to target progranulin, a gene-linked protein, and is being studied in biomarker-selected patients. AL001 has completed Phase 2 clinical development and is not approved for any indication.
AL001 is being developed for frontotemporal dementia, a neurological condition. The clinical program includes patients with frontotemporal dementia, including those with a granulin (GRN) mutation. AL001 is investigational and has not been approved for the treatment of frontotemporal dementia or any other condition.
AL001 targets progranulin, a gene-linked protein. By binding progranulin, the monoclonal antibody is designed to modulate progranulin levels in patients with frontotemporal dementia. The target class is a gene, and the drug is being evaluated in biomarker-selected patients.
AL001 is being developed by Alector, Inc., which trades under the ticker ALEC. Alector is the sponsor of the clinical program for AL001 in frontotemporal dementia.
AL001 has completed Phase 2 clinical development. Two trials have been completed, including a Phase 1 first-in-human study and a Phase 2 long-term dosing study. AL001 is investigational and has not been approved by the FDA for any indication.
AL001 has been studied in two completed trials: NCT03987295, a Phase 2 study of long-term AL001 dosing in frontotemporal dementia (INFRONT-2), and NCT03636204, a Phase 1 first-in-human study in healthy volunteers and participants with frontotemporal dementia with a granulin (GRN) mutation. Both trials are completed.