On January 4, 2011, the Company announced that the study will be conducted under a Special Protocol Assessment (SPA), granted by the United States Food and Drug Administration (FDA). Enrollment in the study began in the fourth quarter of 2010.
Bruce Morimoto, Allon's Vice President of Drug Development, said this trial is a critical step forward in executing the Company's approval strategy for davunetide. "We believe this pivotal trial will generate data in about 2 years, helping form the basis for approval of davunetide in PSP."
"There is a strong scientific rationale for the development of davunetide in this disease. The extensive preclinical data suggests that davunetide works by reducing the tau pathology which is found in PSP and also present in Alzheimer's disease as well as other frontotemporal dementias. Our clinical data also confirms that davunetide can have a positive impact on various clinical outcomes," Morimoto continued.
Matthew Carlyle, Allon's Chief Financial Officer, commented that Allon is in a strong financial position to execute the pivotal study.
"With the closing of a $10.2 million investment in the fourth quarter, we have the resources available to complete the study as agreed upon in the SPA and are able to move forward aggressively," Carlyle said.
The pivotal Phase 2/3 double-blinded, placebo controlled trial in PSP will enroll approximately 300 patients randomized 1:1 to receive either placebo or 30 mg of davunetide twice a day for 12 months. The primary outcome measures will be the Progressive Supranuclear Palsy Rating Scale (PSPRS) and the Schwab and England Activities of Daily Living (SEADL) scale.
Secondary measures will include Clinical Global Impression (CGI) and brain imaging by magnetic resonance tomography (MRI). Additional exploratory endpoints include cognitive and executive function as well as cerebrospinal fluid (CSF) biomarkers.