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Also known as BIIB122
DNL151 · 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 |
DNL151 is an investigational small molecule drug being developed by Biogen Inc. for Parkinson's disease. It is designed to inhibit LRRK2, a gene-linked target implicated in the disease. DNL151 has completed a Phase 1 clinical trial and is not approved for any indication.
DNL151 is being studied as a potential treatment for Parkinson's disease. It is an oral small molecule that targets LRRK2. The drug has been evaluated in a Phase 1 trial in participants with Parkinson's disease, but it is not yet approved for clinical use.
DNL151 targets LRRK2, a gene associated with Parkinson's disease. By inhibiting LRRK2 activity, the drug aims to modulate a pathway implicated in the disease. LRRK2 is a validated genetic target in Parkinson's research, and DNL151 is a small molecule inhibitor of this target.
DNL151 is being developed by Biogen Inc., a biotechnology company traded on the Nasdaq under the ticker BIIB. Biogen is responsible for the clinical development of DNL151 for Parkinson's disease.
DNL151 is in Phase 1 clinical development. It has completed one Phase 1 trial in Parkinson's disease. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
DNL151 has been evaluated in a Phase 1 clinical trial, NCT04056689, titled "Study to Evaluate DNL151 in Subjects With Parkinson's Disease." The trial was completed and enrolled 36 participants across the United States, Belgium, Netherlands, and United Kingdom. It was randomized, double-blind, and placebo-controlled.