Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INS1202 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants with sporadic amyotrophic lateral sclerosis (sALS) will be administered INS1202, IT injection at dose level 1 on Day 1. |
| Cohort 2 | EXPERIMENTAL | Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 2 on Day 1. |
| Cohort 3 | EXPERIMENTAL | Participants with either sALS or SOD1-ALS, will be administered INS1202 via IT injection at dose level 3 on Day 1. |
| Name | Type | Description |
|---|---|---|
| INS1202 | GENETIC | Suspension for injection. |
Key Inclusion Criteria: - * Participant with body mass index (BMI) ≥18 kilograms per square meter (kg/m\^2). * Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria. * Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS. * SOD1...
INS1202 is an investigational gene therapy being developed for amyotrophic lateral sclerosis (ALS). It is designed for patients with ALS and is administered as a single intrathecal injection. The therapy is biomarker-selected, meaning it targets a specific patient population. It is currently in Phase 1 clinical development and has not been approved by the FDA.
INS1202 targets SOD1, a gene that encodes the superoxide dismutase 1 enzyme. Mutations in SOD1 are associated with certain forms of amyotrophic lateral sclerosis. By targeting the SOD1 gene, INS1202 aims to address the underlying genetic cause of the disease in biomarker-selected patients.
INS1202 is being developed by Insmed Incorporated, a biopharmaceutical company traded on the Nasdaq under the ticker symbol INSM. Insmed is responsible for the clinical development of this gene therapy candidate for amyotrophic lateral sclerosis.
INS1202 is in Phase 1 clinical development. The only trial to date is a Phase 1 study that is currently recruiting participants. As an investigational therapy, INS1202 has not been approved by the FDA for any indication.
INS1202 is being evaluated in a single Phase 1 clinical trial, NCT07290062, titled "A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)." The trial is recruiting in the United States and plans to enroll 23 participants.