Tridem Bioscience enrols first patients in phase Ib study of Parkinson’s disease vaccine
Tridem Bioscience, a clinical-stage biopharmaceutical company pioneering active immunotherapy for neurodegeneration, inflammatory skin diseases and atherosclerotic cardiovascular disease (ASCVD), has enrolled the first patients in a Phase Ib clinical study of its lead vaccine candidate, TRB-001, in Parkinson’s disease. The Vienna-based company also reported encouraging data from its named-patient-use (NPU) programme with TRB-001 and said it has completed recruitment for a small proof-of-concept-type Phase I study.
Phase Ib study design
The study will evaluate the safety, immunogenicity and preliminary efficacy biomarkers of Tridem’s intradermal therapeutic vaccine against misfolded alpha-synuclein, with top-line results expected in mid-2027. Parkinson’s disease affects approximately 10 million people worldwide, and current therapies remain symptomatic, with no approved disease-modifying treatment.
“Dosing the first patient in our Phase Ib study is a pivotal moment for Tridem Bioscience and for the patients we aim to serve,” said Markus Mandler, chief executive officer of Tridem Bioscience. “We believe that our TRB-001 WISIT vaccine has the potential to address the underlying pathology of Parkinson’s disease in a way that neither small molecules nor other immunotherapies have been able to achieve thus far. We look forward to reporting clinical results in the coming months.”
Named-patient-use data
Over more than 80 weeks of follow-up in the NPU programme, Tridem has observed a favourable safety profile, high and sustained target-specific antibody levels and encouraging signs of clinical activity. The company reported that antibody
levels measured in humans reflected those achieved in mice and were in the range of monoclonal antibody therapy, indicating an absence of a translational gap, which it describes as a key differentiating attribute of its WISIT platform. It added that the durability of the antibody response supports the feasibility of a practical long-term dosing regimen.
Proof-of-concept study fully recruited
The smaller Phase I study, which applies a boost with TRB-001, is designed to yield first data on potential central target engagement. A lowering of aggregated alpha-synuclein in the cerebrospinal fluid would confirm the mode of action of TRB-001 in humans. Top-line results are expected in January 2027.
Wider pipeline and partnering
Beyond Parkinson’s disease, Tridem has generated promising in vivo proof-of-concept data in Alzheimer’s disease, inflammatory skin diseases and ASCVD. If the absence of a translational gap proves to be a general feature of the technology, the company says, these results indicate meaningful platform potential across multiple chronic diseases, and it plans to advance the programmes to Phase I readiness. Tridem is also seeking strategic co-development and licensing partnerships across its pipeline, is open to a range of deal structures and will be available for partnering meetings at upcoming scientific and industry conferences.