Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB122 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BIIB122 225 mg | EXPERIMENTAL | Oral 225 mg dose, once daily (QD) |
| BIIB122 Matching Placebo | PLACEBO_COMPARATOR | Oral BIIB122 matching placebo, once daily (QD) |
| Name | Type | Description |
|---|---|---|
| BIIB122 225 mg | DRUG | Administered as specified in the treatment arm |
| BIIB122-Matching Placebo | OTHER | Administered as specified in the treatment arm |
Inclusion Criteria: * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years * For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years * Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant. * Have a clinical diagnosis of PD meeting the Mov...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
BIIB122 is an investigational small molecule being studied for the treatment of Parkinson disease, specifically in people with LRRK2-associated Parkinson's disease. It is not yet approved for any indication and remains in clinical development. The ongoing Phase 2 study enrolls participants with this genetically defined form of Parkinson disease.
BIIB122 targets LRRK2, a protein encoded by the leucine-rich repeat kinase 2 gene. LRRK2 is a protein target, and the drug is a small molecule designed to act on it. The Phase 2 trial is specifically testing BIIB122 in participants whose Parkinson disease is associated with LRRK2.
BIIB122 is being developed by Denali Therapeutics Inc., which trades under the ticker DNLI. The company is running the clinical program for this LRRK2-targeted small molecule in Parkinson disease.
BIIB122 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulator. The Phase 2 study is currently active but not recruiting, with 50 participants planned and enrollment completed.
BIIB122 is being studied in one Phase 2 trial, NCT06602193, titled Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease. The trial is active but not recruiting, is randomized, double blind, and placebo controlled, with 50 participants across the United States, Germany, Israel, and Spain.