Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALN-HSD · 1 trial · 1 indication
Change in the continuous qFibrosis score measured by second harmonic generation/two-photon excitation microscopy
| Arm | Type | Description |
|---|---|---|
| ALN-HSD | EXPERIMENTAL | Randomized 1:1 |
| Placebo | PLACEBO_COMPARATOR | Randomized 1:1 |
| Name | Type | Description |
|---|---|---|
| ALN-HSD | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5....
ALN-HSD is an investigational small molecule being developed for Metabolic Dysfunction-Associated SteatoHepatitis (MASH), a chronic liver disease. It is being studied in adult participants who are at increased genetic risk for this condition. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
ALN-HSD is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with Metabolic Dysfunction-Associated SteatoHepatitis (MASH).
ALN-HSD is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The ongoing Phase 2 trial is recruiting participants and is designed to evaluate the drug in adults with Metabolic Dysfunction-Associated SteatoHepatitis (MASH) who have an increased genetic risk for the condition.
ALN-HSD is being studied in one active Phase 2 clinical trial with the identifier NCT05519475. This randomized, double-blind, placebo-controlled trial is recruiting 120 participants across the United States, Japan, Puerto Rico, and South Korea. The study is evaluating the drug in adults aged 18 years and older with Metabolic Dysfunction-Associated SteatoHepatitis (MASH).
ALN-HSD is a small molecule designed to treat Metabolic Dysfunction-Associated SteatoHepatitis (MASH) through a gene silencing approach. The drug targets the underlying genetic factors that increase a person's risk for developing this chronic liver condition. By silencing specific genes, ALN-HSD aims to address the disease process in genetically susceptible individuals.