TABLE 1.
Agent | Sponsor | Type of Therapy | Phase of Development | Clinical Trial Identifier | Status/Findings |
---|---|---|---|---|---|
Active immunization | |||||
AFFITOPE PD01A, (AFF008 Series of studies) |
Affiris | Specific active immunotherapy (a synthetic peptide) | Phase 1 | 2011–002650–31, 2013–001774–20, 2014–002489–54, and 2015–004854–16 (EuraCT numbers) | Measurable humoral antibody response Reduced CSF oligomeric α-Syn; adequate safety and tolerability (Volc et al., 2020) |
NCT02270489 for patients with MSA | Measurable immune response; adequate safety and tolerability (Meissner et al., 2020) | ||||
NCT02618941; NCT01885494; NCT02216188; NCT01568099 | Completed, results pending | ||||
NCT02758730 | Withdrawn | ||||
PD03A (AFF011) | Affiris | Specific active immunotherapy (a synthetic peptide) | Phase 1 | NCT02270489 for patients with MSA | Measurable immune response; adequate safety and tolerability (Meissner et al., 2020) |
NCT02267434 | Completed, results pending | ||||
UB-312 | United Neuroscience Ltd. | Synthetic peptide vaccine | Phase 1 | NCT04075318 | Active, not recruiting |
Passive immunization | |||||
Prasinezumab (RO7046015/PRX002) | Hoffmann-La Roche-Prothena | Humanized IgG1 monoclonal antibody | Phase 1b | NCT02095171 | Adequate safety and tolerability; lowering of free α-Syn in the serum (Schenk et al., 2017) |
NCT02157714 | CSF-serum ratio 0.3% (Jankovic et al., 2018) | ||||
Phase 2 | NCT03100149 | Active not recruiting | |||
NCT04777331 | Recruiting | ||||
BIIB054 (Cinpanemab) |
Biogen | Human IgG1 monoclonal antibody | Phase 1 | NCT03716570 | CSF-serum ratio ranged from 0.13% to 0.56% (Brys et al., 2019) |
Phase 2 | NCT03318523 | Missed primary and secondary endpoints | |||
MEDI1341 | Takeda/AstraZeneca | Monoclonal antibody | Phase 1 |
NCT03272165 NCT04449484 |
Recruiting |
Lu AF82422 | H. Lundbeck A/S | Monoclonal antibody | Phase 1 | NCT03611569 | Recruiting |
ABBV-0805 | AbbVie | Monoclonal antibody | Phase 1 | NCT04127695 | Withdrawn |
ATV: α-Syn | Denali | Antibody | Preclinical | ||
AC Immune | Antibody | Preclinical |