DSMB gives go-ahead to Ph II BRAINz study

Lausanne, Switzerland-based drugmaker Debiopharm says that an independent Data Safety Monitoring Board has received a recommendation to continue its Phase II BRAINz study with Debio 9902 SR (sustained-release) for the treatment of Alzheimer's disease, without modification. "This recommendation by the DSMB authorizing Debiopharm to continue the BRAINz study confirms the safety profile of Debio 9902 SR," said David Wilkinson, of the Moorgreen Hospital, Southampton, and principal trial investigator in the UK, who presented this recommendation at the 10th International Hong Kong Springfield Symposium on Advances in Alzheimer Therapy.

The agent is a novel acetyl cholinesterase inhibitor which is administered once every four weeks. It is transformed non-enzymatically into its active compound, huperzine A (hup A), which 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 the N-methyl-D-aspartate receptor antagonist and 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, Debiopharm noted.