Avraham Pharmaceuticals Announces Commencement of a Phase 2 Study of Ladostigil for the Treatment of Mild Cognitive Impairment
ENROLLMENT HAS BEEN COMPLETED IN A PHASE 2 STUDY OF LADOSTIGIL FOR THE TREATMENT OF ALZHEIMER’S DISEASE AND RESULTS EXPECTED IN Q4 2012
Avraham Pharmaceuticals Ltd. has announced the commencement of a Phase 2 clinical trial to evaluate the safety and efficacy of ladostigil in patients diagnosed with MCI. This 36-month, multi-centre, randomized, double-blind, placebo-controlled trial will include at least 200 patients in 16 centers in Europe and Israel.
In parallel, Avraham Pharmaceuticals has also completed the enrollment of 200 patients in a Phase 2 trial of ladostigil, a novel molecule for the treatment of mild to moderate Alzheimer’s disease. The Phase 2 study is a double-blind, closed-label, placebo-controlled trial taking place at 20 sites in five countries across Europe. In January 2012, the Company performed an interim analysis of this Phase 2 trial, which indicated that the drug is safe and well tolerated, as well as shows a positive trend toward efficacy. Final results of the 26-week trial are expected in the fourth quarter of 2012.
Ladostigil was developed out of the pioneering research into neurodegeneration of Technion Prof. Moussa Youdim.
“We are pleased that another Phase 2 clinical trial in patients with MCI has begun in parallel, and look forward to the final results of the Phase 2 study for the treatment of Alzheimer’s disease expected at the end of this year,” said Yaacov Michlin, Chairman of Avraham Pharmaceuticals.
“I am delighted to lead Avraham in these exciting times for the company, as we advance ladostigil in 2 Phase 2 clinical trials simultaneously. We believe that this unique drug candidate has the potential to transform the treatment of various neurodegenerative diseases,” said Dr. Yona Geffen, Avraham Pharmaceuticals Chief Executive Officer.
Ladostigil is a novel cholinesterase and brain-selective monoamine oxidase inhibitor, and neuroprotective agent for the treatment of Alzheimer’s disease, mild cognitive impairment and other neurodegenerative diseases. The drug, which was exclusively licensed to Avraham Pharmaceuticals by Yissum Research Development Company Ltd., and by the Technion Research and Development Foundation Ltd. (TRDF), has proven to be safe and well tolerated in Phase 1 and Phase 2 clinical trials.
Like other cholinesterase inhibitors currently on the market, ladostigil targets symptomatic relief in Alzheimer’s disease patients. But unlike these drugs, ladostigil, which also causes brain selective inhibition of monoamine oxidase (MAO) provides the potential to improve the behavioral and psychological symptoms of dementia such as depression and anxiety.
Moreover, ladostigil has the potential to slow progression of clinical symptoms of Alzheimer’s disease for sustained periods of time and to modify the pathology associated with the disease. In addition, the neuroprotective activity of ladostigil provides a drug candidate that may have the potential to slow progression to Alzheimer’s disease in patients diagnosed with MCI. This potential has been amply demonstrated in animal models, especially in studies of ageing rats.
Ladostigil was designed by Professor Marta Weinstock-Rosin of the Hebrew University of Jerusalem, inventor of Exelon(R) and Professor Moussa B.H. Youdim of the Technion Israel Institute of Technology, inventor of Azilect(R). The drug substance was first synthesized by Professor Michael Chorev of the Hebrew University, who is now based at Harvard University. All three distinguished scientists act as scientific advisors to Avraham Pharmaceuticals.
About Alzheimer’s Disease
Alzheimer’s disease is the most common cause of dementia worldwide, affecting about one in 20 people 65 years of age or older, accounting for 60-80% of dementia cases. In 2010, 5.4 million people were affected by Alzheimer’s disease in the U.S., where it is the 6th leading cause of death. In Europe, more than 6 million are living with the disease. Approximately half of Alzheimer’s patients also suffer from depression, and up to 40% also exhibit Parkinson-like symptoms.
About Mild Cognitive Impairment
Mild cognitive impairment (MCI) is a syndrome defined as an intermediate stage between the expected cognitive decline of normal aging and the more pronounced decline of dementia. It involves problems with memory, language, thinking and judgment that are greater than typical age-related changes. Although MCI can present with a variety of symptoms, when memory loss is the predominant symptom it is termed “amnestic MCI” and is frequently seen as a prodromal stage of Alzheimer’s disease. Prevalence in population-based epidemiological studies ranges from 3% to 19% in adults older than 65 years. There is no proven treatment or therapy for MCI.
About Avraham Pharmaceutical
Founded in 2010, Avraham Pharmaceuticals has raised more than $12 million to advance the development of its unique, multi-functional drug substance, ladostigil, currently undergoing two Phase 2 clinical trials for the treatment of Alzheimer’s disease and mild cognitive impairment.
SOURCE: Avraham Pharmaceuticals Ltd.
PRESS RELEASE May 17, 2012, 11:36 a.m. EDT