A vaccine being tested in human patients by Dublin-based company United Neurosciences has shown promising results, according to a statement released by the company.
A number of biotechs have aimed to resolve Alzheimer’s via a vaccine over recent years, only to call it off due to nasty side effects like brain swelling. But this drug, which the company has dubbed UB-311, is offering hope after wrapping up a Phase 2a Clinical Study. Next, the drug will begin a 2b study, which will further determine efficacy, before going on to a Phase 3 study if all is successful. Phase 3 is the necessary trial before drug approval and is tested on large groups of patients.
96 percent of patients responded to the drug and showed improved cognition and a lower level of beta-amyloid, the toxic plaque that accumulates in Alzheimer’s patients and the target of the vaccine.
For the Phase 2a study, the drug was tested amongst a group of 42 patients with mild cognitive impairment who were likely in the early stages of Alzheimer’s. The group was divided in three; one was given a placebo and the other two were given the vaccine, administered via shots, three times and then followed up with booster shots either every three or six months.
Of the patients, 96 percent responded to the drug and showed improved cognition and a lower level of beta-amyloid, the toxic plaque that accumulates in Alzheimer’s patients and the target of the vaccine.
“The positive results show that we can safely raise and maintain anti-[beta-amyloid] antibody titers in a predictable and sustained manner,” said Peter Powchik, executive vice president of research and development at United Neurosciences. “High response rates, reproducibility of response and generation of antibodies directed to relevant toxic protein species are key elements of an effective therapeutic vaccine for neurodegenerative conditions. The UNS platform is proving that it can deliver on these requirements.”
And while the results are encouraging enough for United Neurosciences to continue pursuing the vaccine with the same patients, the small number of patients tested means the results are not statistically significant. Additional results will likely be announced in March at the 14th International Conference on Alzheimer’s and Parkinson’s Diseases in Lisbon, Portugal.
“These early results suggest a clinical response and support the continued and rapid development of UB-311. The intent of this Phase 2a study was to acquire directional information on the safety, tolerability and therapeutic potential of UB-311 in patients with Alzheimer’s disease,” said Chief Executive Officer Mei Mei Hu.
A similar vaccine was tested with success on mice by scientists at the University of Texas Southwestern Medical Center and announced in November 2018. Both that vaccine and UB-311 operate under the assumption that beta-amyloid is the cause of the debilitating symptoms of Alzheimer’s, though it’s not an assumption everyone agrees with. In fact, other clinical trials targeting beta-amyloid have recently been called off by drug companies, calling the origin of Alzheimer’s into question.
Regardless, both vaccines would require that older adults get access to early diagnostic tools that could determine who is most at risk for Alzheimer’s and would benefit from a vaccine.