Pilot clinical trial meets primary endpoint with Allon’s davunetide
Allon Therapeutics Inc. announced that a pilot clinical trial successfully met its primary endpoint of safety and tolerability, with the Company’s lead neuroprotective drug candidate davunetide, in patients with progressive supranuclear palsy (PSP) and other types of frontotemporal dementia (FTD) like corticobasal syndrome, and progressive non-fluent aphasia. FTD is a group of rapidly progressive and fatal degenerative brain diseases, often misdiagnosed as Parkinson’s or Alzheimer’s disease.
The new clinical data were presented by Adam Boxer, MD, PhD, the principal investigator of the trial, to the International Conference on Frontotemporal Dementias in Indianapolis, Indiana. Dr. Boxer is an Associate Professor of Neurology at the University of California San Francisco and director of the Alzheimer disease and frontotemporal dementia clinical trials program at the UCSF Memory and Aging Center.
“In this study, davunetide met the primary endpoint of safety over 12 weeks of treatment,” Dr. Boxer said. “This pilot study was small and enrolled three different clinical syndromes of frontotemporal dementia, including progressive supranuclear palsy.”
In addition to the positive safety data, Dr. Boxer reported that the trial also provided the perspectives of PSP patients and their caregivers on the battery of tests proposed for Allon’s efficacy trial. This feedback from patients and caregivers will help Allon and its clinical collaborators conduct the efficacy trial. “The results on the secondary outcome measures, some of which will be used in the Phase 2/3 efficacy trial in progressive supranuclear palsy, are consistent with our expectations,” he said.
Dr. Bruce Morimoto, Allon’s Vice President of Drug Development, said that despite the size and duration of the pilot clinical trial, the investigators noted a positive trend on a secondary outcome, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), a cognitive measure of memory, language, and attention.
“The results from this pilot study are quite encouraging, and support the rationale, design, and duration of our larger Phase 2/3 clinical trial in progressive supranuclear palsy,” Dr. Morimoto said.
Allon intends to develop davunetide as the first approved treatment for PSP, a type of frontotemporal dementia (FTD). The new data confirm earlier clinical safety results in patients with other neurodegenerative diseases and supports the Company’s plans to begin a robust efficacy trial with PSP patients in the near future.
The pilot clinical trial was a 12-week randomized, double-blind, placebo-controlled study of davunetide in 12 patients. During the trial, patients were given 15 milligrams of intranasal davunetide or placebo twice daily.
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