TORONTO, April 18, 2016 /PRNewswire/ - Transition
Therapeutics Inc. ("Transition" or the "Company") (NASDAQ:
TTHI, TSX: TTH) today announced that it has received notification
that Eli Lilly and Co. ("Lilly") will not elect to advance diabetes
drug candidate, TT401 into Phase 3 development. Under the
companies' collaboration agreement, all TT401 development and
commercialization rights will be transferred to
Transition. Transition is unencumbered to advance TT401 on its
own or with a third party.
TT401 is a once-weekly administered oxyntomodulin analog, with
dual agonist activity on the GLP1 and Glucagon receptors. TT401 is
the most clinically advanced drug candidate among the new class of
GLP1-glucagon receptor dual agonists. The product profile for
this class of diabetes drug candidates is to provide type 2
diabetes individuals with blood-glucose control and greater weight
loss than GLP1 single agonists.
In the recently completed Phase 2 study of 420 type 2 diabetes
individuals, the highest dose of TT401 once-weekly administered
peptide demonstrated significantly superior weight loss to
currently approved extended release exenatide and placebo after 12
and 24 weeks of treatment. TT401 also provided similar HbA1c
reduction as exenatide at weeks 12 and 24. The study
demonstrated that TT401 had an acceptable safety and tolerability
profile consistent with GLP-1 single agonists.
"We thank Lilly for their diligent development of
TT401. The Phase 2 study demonstrated that TT401 has a very
competitive product profile as a diabetes therapeutic and was
superior to approved exenatide extended release on weight
loss. As a leader in this new class of therapies, TT401 offers
the unique opportunity of being a first-to-market product with a
differentiated mechanism and activity from currently approved
diabetes therapeutics", said Dr. Tony
Cruz, Chairman and Chief Executive Officer of
Transition.
The royalty that Transition is eligible to receive on sales of
related Lilly compounds remains unaffected. Going forward,
Lilly will be eligible to receive a royalty on future TT401 sales
and a royalty on TT401 non-royalty income.
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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and may be superseded by more recent information we have disclosed
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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.