Allon Therapeutics has completed the enrolment of 300 patients in a Phase II/III pivotal trial to evaluate neuroprotective drug candidate Davunetide as a treatment for progressive supranuclear palsy, a rapidly progressing and fatal degenerative brain disease.
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein.
Earlier human clinical and pre-clinical data suggested that Davunetide has shown significant impacts on memory, activities of daily living, and a biomarker of brain cell function and integrity.
The Phase II/III trial is being conducted under a special protocol assessment, which is based on efficacy demonstrated in patients with amnestic mild cognitive impairment and cognitive impairment associated with schizophrenia.
Allon president and CEO Gordon McCauley said the company expects to complete the treatment phase of the study and release data by the end of 2012.
"We expect that this pivotal study will provide the data sufficient for a regulatory submission for marketing approval," McCauley added.