Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced that the first healthy elderly subjects have been randomised in a clinical bioequivalence bridging study, conducted in the United States under IND (Investigational New Drug).

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 SA. "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.

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates.