Debio 9902 SR (ZT-1) for Alzheimer Patients Debiopharm Starts Tablet Formulations Bridging Study Under IND
News Oct 21, 2008
This study aims to compare the tolerability, safety and pharmacokinetic profiles of a single dose of two different Debio 9902 tablet formulations in healthy elderly subjects. This open label, randomized, crossover bioequivalence bridging study seeks to compare a new tablet formulation with the one used in the Phase IIb BRAINz trial (Better Recollection for Alzheimer's patients with the ImplaNt of ZT-1), which has now completed patient enrolment.
“Our primary objective is to provide a safe, comfortable and effective treatment for Alzheimer patients and the initiation of this bioequivalence trial brings us one step closer to our goal,” said Kamel Besseghir, CEO of Debiopharm S.A. “Indeed, prior to receiving the Debio 9902 SR monthly implant, patients will receive the oral tablet formulation during a run-in period. The new tablet formulation will provide enhanced stability necessary to meet market requirements. ”
Debio 9902 SR is a novel acetylcholinesterase (AChE) inhibitor, administered monthly. It is transformed non-enzymatically into its active compound, huperzine A (hup A). Hup A has been used in China for centuries to treat distinct disorders such as memory loss, schizophrenia and hypertension, and is widely used in North America and Europe as a food additive to enhance cognition and neuroprotection. In addition to the inhibition of acetylcholinesterase by Debio 9902 SR, its potential neuroprotective effects as an N-methyl-D-aspartate receptor antagonist position this product as a third generation treatment for Alzheimer’s disease.