Avraham Pharmaceuticals Ltd. has announced the 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.”