TORONTO, July 17, 2013 /CNW/ - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) announced that
the US Food and Drug Administration (FDA) has granted Fast Track
Designation to the development program for ELND005 which was submitted
for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's
disease (AD). The FDA concluded that the development program for
ELND005 for the treatment of NPS in AD meets their criteria for Fast
Transition's licensing partner, Elan Corporation, plc ("Elan"), is
responsible for all development and commercialization activities and
costs of ELND005.
About Study AG201
The objectives of Study AG201 are to evaluate the efficacy, safety and
tolerability of ELND005 over 12 weeks of treatment in patients with
moderate to severe AD, who are experiencing at least moderate levels of
agitation/aggression. The study is expected to enroll approximately 400
patients at multiple sites in the US, Canada and other selected
regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease
the emergence and severity of specific NPS, an effect which seemed to
correlate with drug exposure for some symptoms. ELND005 also led to a
sustained reduction of brain Myo-inositol levels that are thought to
play a role in phospho-inositol signaling pathways and synaptic
activity. More information on Study ELND005-AG201 is available at http://www.clinicaltrials.gov/.
About Neuropsychiatric Symptoms and Alzheimer's Disease
It is currently estimated that approximately 5.4 million Americans and
approximately 7.2 million Europeans have AD and these numbers are
expected to rise to 16 million by 2050. AD is a progressive brain
disorder that gradually destroys a person's memory and ability to
learn, reason, make judgements, communicate and carry out daily
activities. Approximately 90% of AD patients develop NPS, and up to 60%
develop agitation/aggression over the course of their disease.
Agitation/aggression are among the most disruptive NPS in AD and are
associated with increased morbidity and caregiver burden.
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 β-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 recently published Phase 2
study ELND005-AD201 in AD. ELND005 is also being studied as a
maintenance treatment of Bipolar Disease in an ongoing study (Study
About Fast Track Designation
The fast track programs of the FDA are designed to facilitate the
development and expedite the review of new drugs that are intended to
treat serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs (fast track products). This
designation enables more frequent interactions with the FDA during drug
development and indicates the NDA may be considered for priority
review. In addition, portions of marketing applications for drugs with
Fast Track designation can be submitted before a complete application
is submitted, known as rolling review.
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.
For further information:
For further information on Transition, visit www.transitiontherapeutics.com or contact:
Dr. Tony Cruz
Chief Executive Officer
Transition Therapeutics Inc.
Phone: 416-260-7770, x.223