Allon enrolling patients in pivotal davunetide Phase 2/3 trial
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.
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.
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