YAVNE, Israel -- (BUSINESS WIRE) -- Avraham Pharmaceuticals Ltd. announced today successful interim results in a Phase 2b clinical trial for the evaluation of the safety and efficacy of ladostigil in patients diagnosed with mild cognitive impairment (MCI).
The on-going Phase 2b trial is a 3 years, multi-center, randomized, double-blind, placebo-controlled trial and includes approximately 200 patients in 16 centers in Europe and Israel. An independent expert committee evaluated the safety data on all patients participating in the trial and that have completed at least 1 year of treatment. The expert committee concluded that there are no safety issues preventing continuation of the trial. There were no serious or unexpected adverse events related to the drug.
In addition, the interim results point to a positive trend as to the efficacy of the drug, as evident by various clinical parameters and relevant biomarkers. This includes reduced loss of brain volume as determined by MRI, improved immune system parameters and trends in improvement of cognitive parameters.
Yaacov Michlin, Chairman of Avraham Pharmaceuticals and Chief Executive Officer of Yissum, said, “MCI often progresses to dementia, and in particular to Alzheimer's disease. It is, therefore, a high medical and human interest to be able to delay this progression. This Phase 2 trial is intended to assess the ability of ladostigil, a drug with neuroprotective activity, to slow the cognitive deterioration of people with MCI. We are thus very pleased with the favorable interim results, and look forward to the next interim results, expected at Q3 2015 and the final results at Q3 2016.”
Yona Geffen, Ph.D., Chief Executive Officer of Avraham Pharmaceuticals, said, "Currently there is no treatment for MCI, and we are very encouraged from the positive interim results of the Phase 2b study and previous clinical and pre-clinical data, and believe that ladostigil might be a disease modifying drug that will alleviate MCI symptoms and will prevent progression to Alzheimer's disease.”
Ladostigil was designed by Professor Marta Weinstock-Rosin of the Hebrew University of Jerusalem, inventor of Exelon® and Professor Moussa B.H. Youdim of the Technion Israel Institute of Technology, inventor of Azilect®. 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.
Ladostigil was originally designed as a cholinesterase and brain-selective monoamine oxides inhibitor. However, in low doses that do not inhibit the enzymes, ladostigil has neuroprotective activity, by reducing oxidative stress, reducing microglial activation and inhibiting proinflamtory cytokines. Therefore, 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 aging rats. 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 I and Phase II clinical trials.
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 15% in adults older than 65 years. There is no proven treatment or therapy for MCI.
About Avraham Pharmaceutical
Founded in 2010, Avraham Pharmaceuticals develops ladostigil, a unique, multi-functional drug substance for the treatment of mild cognitive impairment, currently undergoing a Phase IIb clinical trial. Investors in the Company include Yissum Research Development Company Ltd., the technology transfer arm of the Hebrew University Clal Biotechnology Industries Ltd., the Pontifax Fund, Integra Holdings and the Technion Research and Development Foundation Ltd.