LAUSANNE, Switzerland, October 21 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today 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 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."
About Debio 9902 SR (ZT-1)
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.
About Alzheimer's Disease
AD is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. AD is characterised by the progressive destruction of brain cells leading to a decline in mental function and eventually, Alzheimer patients need complete care.
Current estimates show that approximately four million people suffer from AD in the US and 15 million worldwide. Most available treatments produce an increase of the acetylcholine levels by inhibiting AChE, the enzyme responsible for its breakdown. Currently used therapies have significant side-effects which can occur with a frequency of up to 50% for nausea for instance. These treatments generally require complicated titration schemes in order to minimise these cholinergic side-effects, which is a challenge when dealing with memory deficient patients.
An AChE inhibitor with a better tolerance profile than existing treatments and with an easierdosing schedule could improve patient compliance and therefore optimise the patient's treatment.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. It develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing. Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.65 billion in 2007.
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|SOURCE The Debiopharm Group|
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