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news.Allon Therapeutics has recruited almost 75% of the stipulated number of subjects in its Phase 2/3 pivotal trial investigating neuroprotective drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP).
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The trial is being organized in Australia, Canada, France, the UK and the US under a special protocol assessment (SPA) granted by the US Food and Drug Administration (FDA).
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP).
Allon’s human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication between cells, and central to the tau pathway.
Allon said the new imaging data are consistent with the neuroprotective effect of davunetide seen in previous clinical data sets and provide further confirmation of the strategy behind the Company’s Phase 2/3 pivotal trial.
President and CEO Gordon McCauley said they remain hopeful that this pivotal study will provide the data they need to ask for approval in this debilitating neurodegenerative disease.
"We are on track to complete enrolment by the end of 2011 and to report data about a year later," McCauley said.