Capital to be used for completion of on-going Phase 2b study of ladostigil, for treatment of mild cognitive impairment, and preparations for pivotal Phase 3 trial
YAVNE, Israel, February 25, 2016 /PRNewswire/ --
Avraham Pharmaceuticals Ltd. announced today that it has closed an investment round of approximately $4.0 million. Investors in the round include Yissum Research Development Company Ltd., the technology transfer arm of the Hebrew University of Jerusalem, Pontifax, Clal Biotechnology Industries, Integra Holdings, Yissum’s biotech holdings company, the Technion Research and Development Foundation Ltd. (TRDF) and others.
Avraham Pharmaceuticals will use the capital to complete the on-going Phase 2b study of its lead product, ladostigil, a novel molecule designed for the treatment of mild cognitive impairment (MCI) and early stages of Alzheimer’s disease, results of which are expected in the third quarter of 2016. The investment will also support activities in preparation for the next Phase 3 study of ladostigil. These include the establishment of a clinical advisory board which includes key opinion leaders in the fields of MCI and Alzheimer’s disease and a steering committee that will assist the Company in the design of the Phase 3 study. In addition, the capital will be used for preparations for a future pre-IND meeting with the FDA.
“This additional investment is a further vote of confidence from our existing investors in Avraham and ladostigil and will enable us to complete our on-going Phase 2 study with patients suffering from MCI, that is advancing on schedule, and to make the necessary preparations for the next clinical trial, a Phase 3 pivotal study,” commented Dr. Yona Geffen, Avraham Pharmaceuticals Chief Executive Officer. “We believe that ladostigil holds the potential of a disease modifying drug that will alleviate MCI symptoms and prevent progression to Alzheimer’s disease.”
Ladostigil’s on-going Phase 2b trial, for the evaluation of its safety and efficacy in MCI patients, is a 3 years, multi-center, randomized, double-blind, placebo-controlled trial and includes 210 MCI patients in 16 centers in Europe and Israel. In July 2015, following two years of treatment, the Company announced successful interim results, pointing to a positive trend of the ladostigil treated group in comparison to the placebo treated group in the number of patients who did not progress from MCI to Alzheimer’s disease. In addition, an independent expert committee concluded that there are no safety issues preventing continuation of the trial after evaluating safety data on all patients participating in the trial and that have completed at least two years of treatment.
“MCI often progresses to dementia, and in particular to Alzheimer’s disease. Currently there is no treatment for MCI, and there is a high medical need to be able to delay this progression and to slow the deterioration of people with MCI,” Yaacov Michlin, Chairman of Avraham Pharmaceuticals and Chief Executive Officer of Yissum, said. “We are very encouraged from the favorable efficacy trends of the interim results of the Phase 2b study and the excellent safety profile of the drug, and look forward to the final results expected by the end of the year.”
About Ladostigil
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.
For further information please visit our website at http://www.avphar.com/
Media Contact:
Tsipi Haitovsky
Media Liaison, Yissum Ltd.
Tel: +972-52-598-9892
E-mail: tsipih@yissum.co.il
SOURCE Avraham Pharmaceuticals Ltd
