TORONTO, Oct. 28, 2015 /PRNewswire/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (NASDAQ:
TTHI, TSX: TTH) announced today that data from the Phase 2/3
clinical study of ELND005 in Alzheimer's disease patients with
moderate and severe agitation and aggression will be presented at
the Clinical Trials in Alzheimer's Disease (CTAD) meeting on
November 5th, 2015 in Barcelona, Spain. The following oral
presentation will cover the safety and efficacy data from the Phase
2/3 clinical study in the overall study and in the severe agitation
and aggression population.
Oral Presentation # OC-20:
ELND005 for agitation
and aggression in Alzheimer's Disease (HARMONY-AD Study): Phase 2/3
design and clinical outcomes
Authors: A. Porsteinsson
et al.
About ELND005
ELND005 is an orally bioavailable small molecule that is being
investigated for Alzheimer's disease ("AD") and Down syndrome on
the basis of its proposed dual mechanism of action, which includes
β-amyloid anti-aggregation and regulation of brain myo-inositol
levels. A Phase 2/3 study in 350 Alzheimer's disease patients with
moderate or severe agitation and aggression was recently completed.
A review of the study data demonstrated that ELND005
provided a clinically meaningful improvement in agitation and
aggression in a severe patient population. Transition's
subsidiary, TTIL, is seeking guidance from regulators on the design
of Phase 3 clinical studies for the ELND005 program in severe
agitation and aggression in AD patients.
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 and Aggression) in AD. There are no FDA approved
medications for severe agitation and aggression in Alzheimer's
disease.
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 ("TTIL") 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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forward-looking statements, relating to expectations, plans or
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are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
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factors beyond Transition's control and the risk factors and other
cautionary statements discussed in Transition's quarterly and
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SOURCE Transition Therapeutics Inc.