Immungenetics AG initiates 'DrainAD' - a Phase II Clinical Study in Alzheimer's Disease
ACCESS Newswire
ROSTOCK, GERMANY / ACCESSWIRE / November 24, 2017 / Immungenetics AG, a German based biopharmaceutical company focusing on innovative treatments that address unmet medical needs in the field of neurodegenerative, autoimmune diseases and aging, announces the initiation of DrainAD, a Phase II proof-of-concept study for the diagnosis and therapy of Alzheimer's disease.
The purpose of the study, which is partly funded by the German Federal Ministry of Research (BMBF) within the Neuroallianz programme, is to confirm a novel mechanism of action using thiethylperazine as a first-in-class drug. This known drug is approved for the prevention and treatment of nausea, vomiting, and vertigo in Europe since the sixties, and has a well-established safety profile. For the first time, thiethylperazine will be applied for the treatment of Alzheimer's.
As demonstrated in preclinical studies led by Prof Dr. Jens Pahnke (University of Oslo), thiethylperazine activates transporter proteins at the blood-brain-barrier capable of exporting toxic Beta-amyloid from the brain to the bloodstream. 1) This leads to a reduction of the brain's Beta-amyloid burden and may be key to diagnosis and treatment of the disease at early stages.
There is substantial evidence that not overproduction, but impaired clearance of Beta-amyloid from the brain may be responsible for the onset and progression of Alzheimer's disease. 2) Thiethylperazine could help to reduce toxic waste in the brain and support retardation of disease progression.
The prestigious Scientific Advisory Board of the non-profit organization GiveToCure selected DrainAD as one of the top-3 most promising clinical studies to combat the Alzheimer's challenge. The open-label, multicenter, controlled pharmaco-dynamic clinical trial will explore the Amyloid beta draining effect of thiethylperazine in up to 60 evaluable subjects between 55 and 75 of age with early-to-mild dementia due to Alzheimer's Disease in comparison to healthy volunteers. Two different treatment paradigms will be studied. The seven patients and controls of the first group will receive either 26 mg or 52 mg thiethylperazine daily for four consecutive days. Besides the assessment of the safety and tolerability of the drug, primary objective here is to demonstrate a significantly increased efflux of Amyloid beta peptides off the brain into the bloodstream. The second group of 16 patients and controls will be treated with 26mg thiethylperazine daily for 54 days and undergo a standard follow-up period. Among other secondary objectives, changes in cognition due to the thiethylperazine treatment will be assessed.
"The first part of the study will confirm the mechanism of action and determine the diagnostic use. There is an urgent need for a blood-based diagnostic method able to identify people at risk of Alzheimer's disease very early in the process. At a certain age, this test should be part of every regular blood screening. Lumbar puncture and PET scans are advanced and costly procedures that can be selectively conducted afterwards," resumed Antonio Martinez Arbizu, Immungenetics' CEO. "The diagnostic study will be conducted by leading biomarker expert Prof Dr. Jens Wiltfang at the University of Göttingen. In the second part of the study, headed by Prof Lutz Frölich (University Heidelberg-Mannheim) - founder and Board member of the European Alzheimer's Disease Consortium - we will assess cognitive benefits after a three months' administration of thiethylperazine and determine its therapeutic benefits."
Science:
1) Krohn et al. 2011. "Cerebral amyloid-β proteostasis is regulated by the membrane transport protein ABCC1 in mice." J Clin Invest. 2011 Oct 3; 121(10): 3924-3931. 2) Mawuenyega et al. 2010. "Decreased clearance of CNS beta-amyloid in Alzheimer's disease." Science. 2010; 5:1774.
About Neuroallianz
The Neuroallianz Consortium has created a novel strategic partnership where various academic institutions and companies are working jointly on innovative diagnostic and therapeutic research projects. The aim is to efficiently transform research into benefits for the patients.
Main focuses are diagnostic and therapy of neurodegenerative diseases such as Parkinson's Disease or Alzheimer's Dementia, and Epilepsy. The BMBF contributes with 40 million EUR funds from 2009 to 2018. For further information please visit http://www.neuroallianz.de
About cooperating scientists
Prof. Pahnke, neuropathologist and biologist located in Oslo (Norway) focuses on basic molecular mechanisms and new treatment options for neurodegenerative diseases with special emphasis on Alzheimer's disease. He and his team investigate clearance mechanisms of toxic peptides via the blood-brain barrier, new imaging techniques, mitochondrial functions, and neuroimmunological mechanisms. For further information please visit http://pahnkelab.eu/
Prof. Wiltfang (University of Göttingen), director of the clinic for psychiatry and psychotherapy and deputy coordinator of clinical research at the DZNE in Göttingen, is leading expert for biomarkers in Alzheimer's disease and frequently contributing in initial biomarker studies. For further information please visit http://www.psychiatrie.med.uni-goettingen.de/
Prof. Frölich, head of geriatric psychology at the central institute for mental health, Mannheim, mainly focusses on the development and evaluation of novel therapies as well as diagnostic for dementia and imaging methods for psychiatric diseases of the elderly. For further information please visit https://www.zi-mannheim.de/forschung/personen/person/382.html and http://www.eadc.info
About GiveToCure
Give To Cure is the world's first non-profit organization that accelerates drug development by empowering individuals to directly and transparently fund clinical trials. For further information please visit http://www.givetocure.org/members
About Immungenetics AG
Immungenetics AG is a clinical-stage biopharmaceutical company, developing effective treatments for the devastating diseases of aging: for both, major therapeutic areas as well as orphan/rare indications. Current programs involve neurodegeneration, mitochondrial dysfunctions, metabolic syndromes, autoimmune diseases, inflammation, and lifespan.
Headquartered in Rostock (Germany) and with labs in Lübeck and Oslo, the company has created proprietary drug discovery and development platforms which are leading to first-in-class therapies for novel mechanisms of action.
