Date: 2014-07-08
Type of information: Interim results
phase: 2b
Announcement: interim results
Company: Avraham Pharmaceuticals (Israel)
Product: ladostigil [(N-propargyl-(3R) aminoindan-5yl)-ethyl methyl carbamate]
Action
mechanism: Ladostigil is a multimodal drug. It combines neuroprotective effects with monoamine oxidase-A and -B and cholinesterase inhibitory activities in a single molecule. 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.adostigil 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. 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.
Disease: mild cognitive impairment
Therapeutic area: CNS diseases - Neurodegenerative diseases
Country: Europe, Israel
Trial
details: 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.
Latest
news: * On July 8, 2014, Avraham Pharmaceuticals announced 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). These 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. Next interim results are expected at Q3 2015 and the final results at Q3 2016.
