Allon Therapeutics Inc. (NPC.TO) announced today that its pivotal clinical trial evaluating its lead product candidate davunetide as a treatment for progressive supranuclear palsy (PSP) failed to demonstrate efficacy in this population.
The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale (PSPRS), and the Schwab and England Activities of Daily Living (SEADL). Data analysis failed to detect an effect on either the PSPRS or the SEADL. The company said it would undertake further analysis to determine if there was any evidence of an effect or explanation for the absence of an effect.
Following the announcement, the share price of the company, which is traded in Toronto, fell 95%. It now has a market cap of just $3.5 million, after about $70 million were wiped off its value in a matter of minutes. To finance the trial, Allon raised $10 million in a bond offering.
Allon, which specializes in treatments for Alzheimer's disease and other degenerative brain diseases, was founded on the basis of research by Prof. Illana Gozes of Tel Aviv University, and is partly financed by Israeli investors, among them Efi Gildor.
Only a month ago, Allon was chosen as one of the ten most interesting companies for agreements with Big Pharma in neurological diseases at an Elsevier Business Intelligence biomed conference.
Allon president and CEO Gordon McCauley said, "This is a very sad day for patients, family members, and caregivers living with PSP because so many of them held out great hope that these results would define a drug that has an impact on their disease. Sadly these results have not fulfilled these hopes but we are deeply grateful to them for their unrelenting support of this study. While this outcome is not at all what we anticipated, we do believe that we designed the correct study and executed that study well."
Allon said that it would evaluate its strategic options going forward, but it would not allocate any additional capital to research and development activities for davunetide at this time. It will also take immediate action to reduce its ongoing operating expenses including a reduction in staff.
Published by Globes [online], Israel business news - www.globes-online.com - on December 19, 2012
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