Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB094 · 1 trial · 1 indication
An 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 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); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Part A (SAD): BIIB094 Dose 1 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A \[Single Ascending Dose (SAD)\]. |
| Part A (SAD): BIIB094 Dose 2 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 3 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 4 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 5 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 6 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part B (MAD): BIIB094 Dose 1 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 on multiple days during Part B \[Multiple Ascending Dose (MAD)\]. |
| Part B (MAD): BIIB094 (Non LRRK2) Dose 2 | EXPERIMENTAL | Participants \[Non leucine-rich repeat kinase 2 (Non LRRK2)\] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (LRRK2) Dose 2 | EXPERIMENTAL | Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (Non LRRK2) Dose 3 | EXPERIMENTAL | Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (LRRK2) Dose 3 | EXPERIMENTAL | Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part A (SAD): Matching Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo during Part A \[Single Ascending Dose (SAD)\]. |
| Part B (MAD): Matching Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo on multiple days during Part B (MAD). |
| Name | Type | Description |
|---|---|---|
| BIIB094 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * Diagnosed with PD within 7 years at the ...
BIIB094 is an investigational small molecule being developed for the treatment of Parkinson's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in adults with Parkinson's Disease.
The molecular target of BIIB094 has not been disclosed in available information. The drug is being studied for its effects in Parkinson's Disease, but its specific mechanism of action is not publicly detailed. Clinical trials are focused on assessing safety, tolerability, and how the drug is processed in the body.
BIIB094 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IONS. The company is conducting clinical research on this investigational drug for Parkinson's Disease, with the drug currently in Phase 1 development.
BIIB094 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for Parkinson's Disease.
BIIB094 has one completed clinical trial registered as NCT03976349, titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease." This Phase 1 trial enrolled 62 participants across the United States, Canada, Israel, Norway, Spain, and the United Kingdom.
No alternative names for BIIB094 have been disclosed. The drug is identified solely by its development code BIIB094 in clinical trial registrations and public information. It is being studied as a distinct investigational compound for Parkinson's Disease.