Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACI-24 low dose · 1 trial · 1 indication
All subjects who received at least 1 dose of the study treatment of either ACI-24 300 μg, ACI-24 1000 μg or placebo are considered. The measure is expressed in Arbitrary Units per mL (AU/mL). AU/mL in a sample is obtained by back-calculation towards the standard curve.
| Arm | Type | Description |
|---|---|---|
| ACI-24 low dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| ACI-24 high dose | ACTIVE_COMPARATOR | Vaccine formulation will be administrated s.c. 7 times. |
| Placebo | PLACEBO_COMPARATOR | The placebo is ready-to-use solution for injection, administrated s.c. 7 times. |
| Name | Type | Description |
|---|---|---|
| ACI-24 low dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| ACI-24 high dose | BIOLOGICAL | ACI-24 administered as a sterile suspension in PBS via s.c. injection. |
| Placebo | BIOLOGICAL | Placebo is a standard PBS sterile solution administrated via s.c. injection. |
Inclusion Criteria: * Males or females with Down Syndrome aged ≥25 to ≤45 years, with a cytogenetic diagnosis being either Trisomy 21 or Complete Unbalanced Translocation of the Chromosome 21. * Subjects and their study partner/legal representative in the opinion of the investigator able to underst...
Top 2 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Vadadustat |
| Rigel Pharmaceuticals, Inc. | RIGL | 1 | PHASE2 | Fostamatinib |
ACI-24 low dose is an investigational monoclonal antibody developed by AC Immune SA for adults with Down syndrome. It was evaluated in a Phase 1 clinical trial focused on safety, tolerability, and immunogenicity. The low dose refers to a specific dose level studied in that trial, which has been completed.
ACI-24 low dose was studied in adults with Down syndrome. The Phase 1 trial assessed its safety, tolerability, and immunogenicity in this population. It is an investigational product and has not been approved for any indication.
ACI-24 low dose is developed by AC Immune SA, a clinical-stage biopharmaceutical company. The company's ticker symbol is ACIU. AC Immune SA is responsible for the development and clinical evaluation of ACI-24 low dose.
ACI-24 low dose has been evaluated in a Phase 1 clinical trial. The trial is completed. It is an investigational product and has not been approved by the FDA or any regulatory authority.
ACI-24 low dose was studied in one clinical trial: NCT02738450, titled "Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome." This Phase 1 trial enrolled 20 participants in the United States and is completed. It was randomized, double-blind, and placebo-controlled.