Vaxxinity Announces UB-312 Successfully Met Primary Objectives of Phase 1 Clinical Trial in Parkinson’s Disease

UB-312 was immunogenic in patients with early Parkinson’s disease.

UB-312 was generally safe and well-tolerated.

Results are consistent with conclusions from Phase 1 Part A and preclinical studies, and support advancement of UB-312 into further clinical development.

CAPE CANAVERAL, Fla., June 22, 2023 (GLOBE NEWSWIRE) --  Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines today announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson’s disease (PD), demonstrating UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the primary objectives of the trial.

“These positive Phase 1 results demonstrate several important features necessary for an immunotherapy against Parkinson’s disease and other synucleinopathies to be successful, and represent a further proof-of-principle for Vaxxinity’s platform in chronic disease,” said Mei Mei Hu, CEO of Vaxxinity. “UB-312 was observed to safely break immune tolerance, inducing antibodies against toxic aggregated forms of alpha-synuclein. Importantly, these antibodies crossed the blood brain barrier, and the data also suggest potential target engagement in the periphery, where pathological alpha-synuclein is known to be concentrated. Together these results support the further development of UB-312 in a Phase 2 clinical trial. We continue to view UB-312 as a promising candidate for the prevention or disease modification of Parkinson’s disease globally.”

UB-312 is an investigational synthetic peptide vaccine that targets toxic forms of aggregated aSyn to address PD and other synucleinopathies. Alpha-synuclein plays a central role in synaptic functions and regulation of neurotransmitter release. The accumulation and aggregation of misfolded aSyn in the brain is considered to be a key factor in the development and progression of PD.

The Phase 1 placebo-controlled, double-blind clinical trial of UB-312 consisted of two parts: Part A tested escalating doses of UB-312 versus placebo in 50 healthy volunteers aged 40 to 85 years, and Part B tested two doses of UB-312 versus placebo in 20 age-matched subjects with early PD (Hoehn & Yahr stage ≤ III), both conducted at the Centre for Human Drug Research (CHDR), an independent institute in the Netherlands. Results from Part A, published in Movement Disorders in 2022, suggested that UB-312 is highly immunogenic, with all individuals in the target dose group showing detectable anti-aSyn antibodies in both serum and cerebrospinal fluid (CSF).