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BIIB115 · 1 trial · 2 indications
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort 1: BIIB115 Dose 1 | EXPERIMENTAL | Participants will receive a single dose of BIIB115, Dose 1, via IT bolus injection, on Day 1. |
| Part A: Cohort 2: BIIB115 Dose 2 | EXPERIMENTAL | Participants will receive a single dose of BIIB115, Dose 2, via IT bolus injection, on Day 1. |
| Part A: Cohort 3:BIIB115 Dose 3 | EXPERIMENTAL | Participants will receive a single dose of BIIB115, Dose 3, via IT bolus injection, on Day 1. |
| Part A: Cohort 4: BIIB115 Dose 4 | EXPERIMENTAL | Participants will receive a single dose of BIIB115, Dose 4, via IT bolus injection, on Day 1. |
| Part A: Cohorts 1-4: BIIB115-Matching Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of BIIB115-matching placebo, via IT bolus injection, on Day 1. |
| Part B: Cohort 5: BIIB115 Dose 3 | EXPERIMENTAL | Pediatric SMA participants previously treated with onasemnogene abeparvovec will receive two doses of BIIB115, Dose 3, via IT bolus injection at two separate time points. |
| Part B: Cohort 6: BIIB115 Dose 4 | EXPERIMENTAL | Pediatric SMA participants previously treated with onasemnogene abeparvovec will receive two doses of BIIB115, Dose 4, via IT bolus injectionat two separate time points. |
| Part B: Long Term Extension (LTE): BIIB115 Dose 4 | EXPERIMENTAL | Pediatric SMA participants previously treated with onasemnogene abeparvovec who have completed Part B and are eligible will receive five doses of BIIB115, Dose 4, via IT bolus injection at separate time points for up to 60-month duration. |
| Name | Type | Description |
|---|---|---|
| BIIB115 | DRUG | Administered as specified in the treatment arm |
| BIIB115-Matching Placebo | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: Part A: * Male healthy participants aged 18 to 55 years, inclusive * Have a body mass index of 18 to 30 kilograms per meter square (kg/m\^2), inclusive * Must be in good health as determined by the investigator, based on medical history and screening evaluations Part B: *...
BIIB115 is an investigational small molecule being developed by Biogen for neurology. It is currently in Phase 1 clinical trials studying its safety and how it is processed in healthy adult male volunteers and pediatric participants with spinal muscular atrophy who previously took onasemnogene abeparvovec.
BIIB115 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The drug is currently in Phase 1 clinical development.
BIIB115 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
BIIB115 is being studied in a Phase 1 clinical trial with the identifier NCT05575011. This randomized, double-blind, placebo-controlled trial has an enrollment of 62 participants and is being conducted in Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Korea, and the United Kingdom.
Yes, BIIB115 is a small molecule drug. It is being developed by Biogen for the treatment of spinal muscular atrophy, a neurological condition. The drug is currently in Phase 1 clinical trials.