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ALN-6457 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | - |
| Cohort Expansion | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALN-6457 | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Participant must meet all of the criteria under either: 1. sporadic CJD as described in the protocol or 2. genetic PrD, as described in the protocol 2. Has a Body Mass Index (BMI) \<35 kg/m2 (inclusive) at the screening visit 3. Able to understand and complete tria...
ALN-6457 is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN) for the treatment of prion disease. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program is focused on adult participants with symptomatic prion disease.
ALN-6457 is being studied for the treatment of prion disease, a rare and progressive neurodegenerative condition. The only registered trial enrolls adult participants with symptomatic prion disease. Because the drug remains in Phase 1 testing, it is investigational and is not available as an approved therapy for prion disease or any other indication.
Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN, is the developer of ALN-6457. The company is running the Phase 1 program for the asset in prion disease. Regeneron is the sponsor of record for the trial listed on ClinicalTrials.gov.
ALN-6457 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The program currently consists of a single Phase 1 trial in adult participants with symptomatic prion disease, and that trial has not yet begun recruiting.
ALN-6457 is being evaluated in one registered clinical trial, NCT07832370, titled A Trial of ALN-6457 in Adult Participants With Symptomatic Prion Disease (PrD). The Phase 1 study is controlled, is not yet recruiting, and plans to enroll 60 participants aged 18 years and older, with no healthy volunteer enrollment.
The Phase 1 trial of ALN-6457, NCT07832370, plans to enroll 60 adult participants with symptomatic prion disease. Enrollment has not started because the study status is not yet recruiting. The trial is controlled and enrolls participants aged 18 years and older of any sex.