TORONTO, Nov. 24, 2014 /PRNewswire/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX:TTH) today announced
results from a thorough QT (tQT) study in which no QT effects were
observed at supra-therapeutic single doses of neuropsychiatric drug
candidate, ELND005. A tQT study is a specialized clinical trial
required by the United States Food and Drug Administration ("FDA") for
the approval of most drugs in development. Transition's wholly-owned
subsidiary, Transition Therapeutics Ireland Limited ("TTIL") presented
the tQT study data at the Clinical Trials in Alzheimer's Disease
conference on November 21, 2014.
From a safety perspective, drugs that have no QT prolongation effects
are particularly desirable for administration to an elderly Alzheimer's
disease ("AD") population. AD patients are especially challenging for
novel drug development, since they typically have multiple medical
co-morbidities and receive multiple medications. The use of some
anti-psychotics and anti-depressants may increase the risk of QT
prolongation, arrhythmias, and sudden death in AD patients.
Single doses, 2000mg and 7000mg of ELND005, appeared to be safe and
well-tolerated by healthy subjects in this study. ELND005 exposures in
this study are five-fold higher than the loading dose of 1000mg BID in
the current Agitation and Aggression in AD clinical study (AG201).
These ELND005 doses did not have any clinically relevant effects on
electrocardiogram ("ECG") parameters and the study represents a clearly
negative thorough QT (tQT) study.
About the ELND005 tQT Study
The QT interval represents the amount of time the heart's electrical
system takes to repolarize, or recharge, after each beat. As
prolongation of the QT interval may increase the risk for cardiac
arrhythmias, the FDA requires a tQT study for most new drugs in
development. A tQT study is a specialized clinical trial designed to
assess whether an investigational medication has the potential to
prolong the QT interval.
Study Design
The tQT study was a partially double-blind (in regard to ELND005
treatment), randomized, placebo- and active controlled, 4-arm crossover
trial in 52 healthy male and female subjects using single doses during
separate treatment periods, and undergoing intensive ECG monitoring.
Each subject received a single oral dose of the following 4 treatments:
2000 mg ELND005, 7000 mg ELND005, placebo as a negative control, and
400 mg moxifloxacin as a positive control. The central ECG
laboratory was blinded to subjects, time, and all treatments (including
positive control) when performing the ECG reading.
About ELND005
ELND005 is an orally bioavailable small molecule that is being
investigated for multiple neuropsychiatric indications on the basis of
its proposed dual mechanism of action, which includes β-amyloid
anti-aggregation and regulation of brain myo-inositol levels. An
extensive clinical program of Phase 1 and Phase 2 studies has been
completed with ELND005 to support clinical development, including the
published Phase 2 study ELND005-AD201 in Alzheimer's disease ("AD").
ELND005 is also being studied as a potential treatment of agitation and
aggression in Alzheimer's disease (Study ELND005-AG201), and as a
therapy for those with Down syndrome (Study ELND005-DS-201). ELND005
has received fast track designation from the psychiatry division of the
United States Food and Drug Administration for its potential as a
treatment of Neuropsychiatric Symptoms (including Agitation) in AD.
About Transition
Transition is a biopharmaceutical development company, advancing novel
therapeutics for CNS and metabolic disease indications. The Company's
wholly-owned subsidiary, Transition Therapeutics Ireland Limited is
developing CNS drug candidate ELND005 for the treatment of Alzheimer's
disease and Down syndrome. Transition's lead metabolic drug candidate
is TT401 (LY2944876) for the treatment of type 2 diabetes and
accompanying obesity. The Company's shares are listed on the NASDAQ
under the symbol "TTHI" and the Toronto Stock Exchange under the symbol
"TTH". For additional information about the Company, please visit www.transitiontherapeutics.com.
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SOURCE Transition Therapeutics Inc.