Allon Therapeutics Inc. has updated the progress of a Phase 2/3 clinical trial that is evaluating the company’s lead neuroprotective drug candidate, davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.
Gordon McCauley, Allon’s president and chief executive officer, said the trial has enrolled approximately 50% of the 300 patients specified in the protocol. Enrollment began in the fourth quarter of 2010.
The trial is being conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA’s expectations for a pivotal study. The company expects to complete enrollment by the end of 2011.
McCauley said the trial’s Data Safety and Monitoring Board (DSMB) approved the continuation of the trial. The multi-national study is being conducted at medical institutions in the United States, Canada, the United Kingdom, France, Germany, and Australia.
Release Date: May 18, 2011
Source: Allon Therapeutics Inc.
Filed Under: Drug Discovery