Biotechnology company Vaxxinity, whose focus is developing vaccines to treat chronic diseases, announced the results of Part B of a Phase 1 study of its experimental vaccine for Parkinson’s disease, UB-312. UB-312 contains a synthetic piece of alpha-synuclein, a protein implicated in neurodegeneration in diseases like Parkinson’s and other synucleinopathies, and stimulates the body to produce antibodies against it.
In a preclinical trial, UB-312 prevented the accumulation of alpha-synuclein and improved motor function in a mouse model of synucleinopathies. Part A of the Phase 1 trial tested the vaccine in 40 healthy volunteers and showed that UB-312 was safe and well tolerated and that it effectively crossed the blood-brain barrier.
Part B tested 100- and 300-mg doses of UB-312 in patients with early to moderate Parkinson’s disease for 20 weeks plus a 24-week follow-up period. Study results demonstrated that UB-312 broke immune tolerance in 12 of the 13 patients who completed dosing and reduced levels of aggregated alpha-synuclein compared to placebo. “We have observed clear target engagement with aggregated alpha-synuclein in patient CSF, indicating that UB-312-induced antibodies cross the blood-brain barrier and engaged the toxic pathology of Parkinson’s disease,” said Vaxxinity CEO Mei Mei Hu.
Vaxxinity is studying UB-312 for the treatment of dementia with Lewy bodies and multiple system atrophy and has published results from a Phase 2a study of UB-311, which targets aggregated amyloid-β in mild Alzheimer’s disease.
