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United Neuroscience Touts Positive Phase 1 Results for Active Vaccine UB-311 in Alzheimer's Disease.

M2 PHARMA-May 24, 2017-United Neuroscience Touts Positive Phase 1 Results for Active Vaccine UB-311 in Alzheimer's Disease

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- US-based biotechnology company United Neuroscience has posted positive Phase 1 data for UB-311, its novel synthetic peptide vaccine targeting beta amyloid in the treatment of AD, the company said.

The Phase 1 data, which was published in the Alzheimer's and Dementia: Translational Research and Clinical Interventions journal from the Alzheimer's Association, showed that UB-311 was safe and well-tolerated with a 100% response rate and high anti-A? antibody titers across patients.

The insidious, decades-long buildup of misfolded A? oligomers, fibrils and amyloid plaques is believed to play a pivotal role in brain cell injury leading to dementia and is a major focus for drug development efforts.

Several late stage clinical trials are currently testing passive immunotherapy with monoclonal antibodies targeting A? with some reporting encouraging results.

Active vaccination of human individuals against A? has also long been pursued but has yet to be effectively achieved.

Most active vaccine efforts have either reported low antibody titers and responder rates or significant safety issues such as T-cell mediated encephalitis. UB-311 is a novel UBITh active vaccine targeting the N-terminus of A?, designed to induce high B-cell specific responses while avoiding T-cell inflammation.

UB-311 was previously shown to generate considerable site-specific antibodies across mice, guinea pigs, macaques and baboons and to also reduce A?1-42 oligomers, protofibrils, and plaque load in the transgenic hAPP751 mouse model of AD.

In the UB-311 first-in-human trial reported TODAY, 19 patients with mild-to-moderate AD were immunized with three doses of the vaccine at enrollment, four weeks and 12 weeks, and monitored until week 48.

No major adverse events were reported in the study, including absence of ARIA-E, a treatment emergent safety issue that has plagued other anti-A? mAbs in development, the company said.

Injection site swelling and agitation were the most common adverse events reported. Immunogenicity results showed that UB-311 vaccination had a 100% responder rate and induced strong anti-A? antibody titers that preferentially recognized the aggregated forms of A?.

In a small subgroup of patients with mild AD over 60 years of age, stabilization or improvement in three cognitive scales from baseline to week 48 was observed.

UNS' ongoing Phase 2 active immunotherapy trial of UB-311 in early-to-mild AD patients is fully enrolled. Results from the Phase 2 trial are expected in mid-2018.

United Neuroscience is a clinical-stage biotech company dedicated to the development of immunotherapeutics for the brain.

UNS was founded to address the social and economic burden of Alzheimer's and other neurodegenerative diseases and seeks to rapidly advance candidates into and through clinical trials with the goal of delivering breakthrough treatments to patients.

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Publication:M2 Pharma
Date:May 24, 2017
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