Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule being developed for frontotemporal dementia (FTD), specifically in participants with a granulin (GRN) mutation, and has also been studied in healthy volunteers. It is in clinical development for neurology, with completed Phase 1 and Phase 2 trials.
AL001 is being developed by Alector, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ALEC. The company has conducted clinical trials of AL001 in the United States, Canada, the United Kingdom, Germany, Italy, and the Netherlands.
AL001 is in Phase 2 clinical development. It has completed a Phase 1 first-in-human study and a Phase 2 long-term safety study in frontotemporal dementia patients. AL001 is investigational and not yet approved by regulatory authorities.
AL001 has been studied in two completed trials: NCT03636204, a Phase 1 first-in-human study in healthy volunteers and FTD participants with GRN mutations, and NCT03987295, a Phase 2 study (INFRONT-2) evaluating long-term safety of AL001 dosing in FTD patients.
AL001 is the primary name for this investigational small molecule developed by Alector. No alternative names have been reported in the clinical trial records, which reference it consistently as AL001 across both the Phase 1 and Phase 2 studies.