WASHINGTON--(BUSINESS WIRE)--Biotech firm AXON Neuroscience has presented encouraging results from a Phase 1 study with a vaccine designed to target diseased tau proteins in Alzheimer’s patients. AXON is not only the first company to successfully complete a Phase 1 study with an active tau vaccine, but the first to show excellent safety profile with an active treatment in Alzheimer’s research.
AADVAC1 TAU VACCINE PHASE I RESULTS
In July 2013, AXON Neuroscience initiated a Phase I study, evaluating its immunotherapy against diseased tau protein that causes neural degeneration in Alzheimer’s patients. The vaccine is designed to be active--meaning that it stimulates patients‘ immune systems to attack the dysfunctional tau proteins, and halts the progress of Alzheimer’s disease. The primary goal of the Phase I study was to assess safety and tolerability of this compound. The study was performed on 30 patients suffering from Alzheimer’s disease in four different clinical sites in Austria and successfully completed in March of this year.
According to coordinating investigator Professor Reinhold Schmidt from Medical University Graz, who presented the results at the at the Alzheimer’s Association International Conference 2015 (AAIC) in Washington D.C., the vaccine is safe and well tolerated in all assessed parameters. Additionally, the treatment induced robust immune response in vast majority of the study participants and the average cognition of patients remained stable over 6 months. These promising results lead to big expectations in the upcoming Phase II study.
TAU AS A DRIVING FORCE IN ALZHEIMER’S
The researchers at AXON Neuroscience have extensively worked on tau hypothesis for more than 25 years. Through the years, they have proven in various experiments that tau is the driving force in Alzheimer’s disease. This was also recently confirmed by the researchers at Mayo Clinic, USA, who have found by examining more than 3,600 postmortem brains that the progression of dysfunctional tau protein drives the cognitive decline and memory loss seen in Alzheimer's disease.
NEXT DEVELOPMENT OF AADVAC1 VACCINE
The promising results have provided a strong basis for further development of the vaccine clinical program, So this year, AXON Neuroscience is beginning a Phase II study, where the primary goal is to confirm these positive results by assessing safety and immunogenicity on a larger sample of patients with mild Alzheimer’s disease. As a second objective, the study will evaluate the effect of the AADvac1 vaccine in slowing down or halting the cognitive decline in patients over the period of 24 months.
“Having seen the robust immune response and stabilized cognition in Phase I, this makes us to expect the same effect in Phase II” said Prof. Michal Novak, AXON’s CSO.
MISSION OF AXON NEUROSCIENCE
AXON Neuroscience is a clinical-stage biotech company developing disease-modifying therapeutics for Alzheimer's disease and other tauopathies.
“By successfully validating step-by-step the clinical development pathway, we believe that our vaccine can reach the market in early 2020’s and deliver the relief to millions of patients over the world” said Roman Sivak, AXON’s CEO. He added “we can feel the high unmet need not only of the AD sufferers, but mainly the affected closest relatives, and even the economic burden of the nations-- therefore our duty is to translate the 30 years of excellent science into a successful therapy.”
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