Allon Therapeutics Inc. announced Wednesday it has reached agreement with the U.S. Food and Drug Administration (USFDA) on what will be the next big step for its product davunetide.
Allon and the USFDA agreed to a special protocol assessment (SPA) for pivotal Phase 2 and 3 clinical trials to evaluate Allon’s (TSX:NPC) lead neuroprotective drug candidate, davunetide, as a potential treatment for progressive supranuclear palsy, a rapidly progressing and fatal degenerative brain disease.
That SPA is a mechanism through which the USFDA and Allon reach agreement on the design, size and clinical endpoints and data analysis of a clinical trial intended to support an efficacy claim in a new drug application for regulatory approval.
Business in Vancouver has previously reported that Allon was awarded US$500,000 in grants from the U.S. government to fund development of davunetide. (See “U.S. government providing US$500,000 to Allon Therapeutics” – BIV Business Today, November 4, 2010.)
Allon’s CEO Gordon McCauley said the SPA agreement gives Allon a clear path to develop davunetide for the treatment of progressive supranuclear palsy and provides a foundation for further development in other brain diseases.