Transition Therapeutics Announces Dosing of the First Patient in Phase 2a Study of ELND005 in Down Syndrome
TORONTO, Sept. 4, 2013 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX: TTH) announced the
first patient dosing in a Phase 2a study of ELND005 in Down syndrome.
Study ELND005-DS201 will evaluate the safety and pharmacokinetics of
two doses of ELND005 and placebo in young adults with Down syndrome
without dementia, and will also include select cognitive and
behavioural measures. Information on the study design and protocol for
ELND005-DS201 can be found at http://clinicaltrials.gov/. The first person was dosed at the site of Dr. Ira Lott, Professor of
Neurology and Pediatrics and Down syndrome expert at the University of
Transition’s licensing partner, Elan Corporation, plc (“Elan”), is
responsible for all development and commercialization activities and
costs of ELND005.
About Down Syndrome
Down syndrome (DS, Trisomy 21), caused by an extra copy of chromosome
21, is the most common genetic form of intellectual disability with a
prevalence of approximately 1 in 700 live births in the US. Children
with DS exhibit developmental delay and various degrees of intellectual
disability, while adults are at increased risk of Alzheimer’s dementia.
There are currently no drugs approved for the treatment of cognitive
dysfunction in DS.
Excess activity of genes on chromosome 21, such as amyloid precursor
protein (APP) and sodium-myo-inositol active transporter (SMIT), are
thought to play a role in the cognitive dysfunction of DS. Life-long
exposure to increased amyloid and myo-inositol levels in the brain are
thought to lead to synaptic dysfunction and cognitive disability.
ELND005 may have the potential to improve cognition in persons with DS
by decreasing amyloid levels and regulating myo-inositol-dependent
ELND005 is an orally bioavailable small molecule that is being
investigated by Transition’s licensing partner, Elan, for multiple
neuropsychiatric indications on the basis of its proposed dual
mechanism of action, which includes b-amyloid anti-aggregation and
regulation of brain myo-inositol levels. An extensive clinical program
of Phase 1 and Phase 2 studies have been completed with ELND005 to
support clinical development, including the published Phase 2 study
ELND005-AD201 in AD. ELND005 is also being studied as a potential
treatment of agitation and aggression in Alzheimer’s disease (Study
ELND005-AG201) and as a maintenance therapy of Bipolar Disorder Type I
Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. The Company’s lead CNS drug
candidate is ELND005 for the treatment of Alzheimer’s disease and
bipolar disorder. Transition’s lead metabolic drug candidate is TT-401
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.
Notice to Readers: Information contained in our press releases should be
considered accurate only as of the date of the release and may be
superseded by more recent information we have disclosed in later press
releases, filings with the OSC, SEC or otherwise. Except for historical
information, this press release may contain forward-looking statements,
relating to expectations, plans or prospects for Transition, including
conducting clinical trials and potential efficacy of its products.
These statements are based upon the current expectations and beliefs of
Transition’s management and are subject to certain risks and
uncertainties that could cause actual results to differ materially from
those described in the forward-looking statements. These risks and
uncertainties include factors beyond Transition’s control and the risk
factors and other cautionary statements discussed in Transition’s
quarterly and annual filings with the Canadian commissions.
SOURCE Transition Therapeutics Inc.