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 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.
For more information on Debiopharm Group, please visit:
debiopharm.
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