Allon Therapeutics Inc. (TSX: NPC) yesterday announced that the Phase IIa clinical trial of its lead candidate davunetide achieved measurable positive treatment effects in schizophrenia patients with cognitive impairment.
Allon's share rose 9.4% at the opening on the Toronto Stock Market today to C$0.29, after rising 5% yesterday. Its market cap is C$22.6 million, less than half it market cap when it released preliminary results of the trial in July.
In a presentation to a US neuropsychopharmacology scientific conference in Florida, Allon said that the trial did not achieve statistical significance on the primary endpoint, which was the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) composite battery of tests. However, numerical positive treatment effects were seen in specific tests that measured visual learning and working memory. A change was observed in verbal learning favoring placebo.
The trial achieved a statistically significant positive treatment effect on a secondary endpoint, which was the University of California at San Diego Performance-based Skills Assessment (UPSA) test. The UPSA scale assesses the functional capacity of skills for daily living and has been recognized by drug regulators as an appropriate co-primary endpoint in patients suffering from schizophrenia-related cognitive impairment.
Vancouver-based Allon Therapeutics is based on a product developed by Prof. Illana Gozes at the Weizmann Institute of Science and Tel Aviv University, and commercialized by Ramot at Tel Aviv University Ltd. The trial was mainly funded by US National Institutes of Health unit National Institute of Mental Health (NIMH). Dr. Daniel Javitt of the Nathan Kline Institute for Psychiatric Research in Orangeburg, New York, is the lead study investigator. He said that the results supports and augments preliminary results published in July.
BiolineRX Ltd. (TASE:BLRX) is also developing a treatment for schizophrenia-related cognitive impairment. The company is in talks with several international drug companies to commercialize its product, after it obtained statistically significant results in its clinical trial.
Allon Therapeutics and BiolineRX could find themselves in direct competition. However, Allon may decide to initially focus on its treatment for Alzheimer's disease, which it has shown similar results in Phase IIa clinical trials. BiolineRX's product is primarily a treatment for controlling psychotic schizophrenia episodes, but with fewer side effects than current drugs on the market, whereas Allon's drug is presented as a supplementary treatment targeting patients' cognitive functioning.
Published by Globes [online], Israel business news - www.globes-online.com - on December 8, 2009
© Copyright of Globes Publisher Itonut (1983) Ltd. 2009