Debiopharm begins phase II study for Alzheimer's cure
Enrols first patient in phase II study with Debio-9902 SR implants (formerly ZT-1)
Independent biopharmaceutical development company Debiopharm has enrolled its first patient in the phase II study with DEBIO-9902 SR implants (formerly ZT-1), the first monthly sustained-release acteylcholinesterase (AChE) inhibitor being developed for Alzheimer's patients.
The study will measure the safety and efficacy of DEBIO-9902 SR implants, in comparison with oral donepezil, in a clinical trial named "BRAINz" (Better Recollection for Alzheimer's patients with ImplaNts of ZT-1).
"This is a promising new therapeutic approach," said David Wilkinson, MARC, Moorgreen Hospital, Southampton, England and Principal Investigator in the UK. "The DEBIO-9902 SR implant provides a new treatment alternative with the potential for better tolerance through a progressive, steady release of the active compound. This becomes an important factor in terms of compliance and efficacy for Alzheimer's patient who may find taking regular oral medication difficult or distressing."
The phase II, double blind, double dummy clinical trial with DEBIO-9902 SR will be conducted on three continents. Results are expected during the first half of 2008.
Headquartered in Lausanne, Switzerland, Debiopharm is seeking a partner for further development and commercialisation of DEBIO-9902.Current estimates show that approximately four million people suffer from AD in the US and 15 million worldwide.
An AChE inhibitor with a better tolerance profile than existing treatments and with an easier dosing schedule could improve patient compliance and therefore optimise the patient's treatment.
DEBIO-9902 SR is a novel AChE inhibitor that 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.
The dual mode of action of DEBIO-9902 SR as a N-methyl-D-aspartate receptor antagonist and an AChE inhibitor, positions it as a third generation anti-Alzheimer's product by improving the general condition and cognitive functions of affected patients as well as having the potential of being a neuroprotectant.