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Also known as BIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151), DNL151
BIIB122 · 2 trials · 2 indications
Time to confirmed worsening is defined as a worsening event sustained over 2 consecutive assessments. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be completed by the participant. Part III assesses the motor signs of PD and is administered by the rater (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Part II and III combined score equals the sum of Parts II and III (Range 0-184). A higher score indicates more severe symptoms of PD.
| Arm | Type | Description |
|---|---|---|
| BIIB122 225 mg | EXPERIMENTAL | Participants will receive BIIB122, 225 mg tablets, by mouth, once daily (QD) for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received BIIB122 and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122, 225 mg tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. |
| BIIB122 Matching Placebo | PLACEBO_COMPARATOR | Participants will receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. Participants who received placebo and completed the ET visit of study 283PD302 (NCT05418673) will continue to receive BIIB122 matching placebo tablets, by mouth, QD for up to a minimum of 48 weeks and a maximum of 144 weeks. |
| DNL151 Low Dose | EXPERIMENTAL | - |
| DNL151 Mid Dose | EXPERIMENTAL | - |
| DNL151 High Dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BIIB122 | DRUG | Administered as specified in the treatment arm |
| BIIB122-Matching Placebo | DRUG | Administered as specified in the treatment arm |
| DNL151 | DRUG | Oral repeating dose |
| Placebo | DRUG | Oral repeating dose |
Key Inclusion Criteria: * Clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria within 2 years of the Screening Visit, inclusive, and at least 30 years of age at the time of diagnosis * Modified Hoehn and Yahr scale stages 1 to 2 (in OFF state), inclusive, at s...
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 |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| 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. It is designed to slow the worsening of early-stage Parkinson disease in adults between the ages of 30 and 80. It is not approved for any indication and remains in clinical development.
BIIB122 targets LRRK2, a gene that encodes leucine-rich repeat kinase 2. LRRK2 is a gene target, and the drug is a small molecule directed at it. Targeting LRRK2 is being explored as an approach to slow the worsening of early-stage Parkinson disease.
BIIB122 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating the drug in Parkinson disease.
BIIB122 is in Phase 2 clinical development. It is an investigational drug and is not FDA approved. The Phase 2 study has been completed, and no trials are currently active.
BIIB122 has been studied in one Phase 2 trial, NCT05348785, titled a study to learn about the safety of BIIB122 tablets and whether they can slow the worsening of early-stage Parkinson disease in adults aged 30 to 80. The trial enrolled 650 participants, was randomized, double-blind, and placebo-controlled, and is completed.
Yes. BIIB122 is also known as DNL151, and the carbon-14 labeled form is referred to as [14C] BIIB122 or [14C] DNL151. These names refer to the same investigational LRRK2-targeted small molecule being developed by Biogen for Parkinson disease.