Transition TherapeuticsÂ and Novo Nordisk End Diabetes Agreement
TORONTO, Nov. 5 - Transition Therapeutics today announces an update on the clinical development and partnership activities for the Company's diabetes programs. Following good faith negotiations, Novo Nordisk A/S and Transition were not able to come to agreement for an exclusive license to the Company's diabetes programs. Accordingly, Transition has sent notice to Novo Nordisk A/S terminating the agreement between the companies, which will return to Transition all rights held by Novo Nordisk A/S, relating to E1-I.N.T. Transition will continue on-going discussions with other interested parties to partner the diabetes programs. In the interim, the Company is fully committed to support and advance the clinical development of the diabetes programs, leveraging its expertise in disease-modifying therapies for diabetes, world-class scientific advisory board and solid financial position.
Preclinical data in diabetes animal models demonstrate the efficacy of gastrin analogues alone, or in combination with GLP-1 analogues or epidermal growth factor analogues. In humans, Transition's recent Phase IIa clinical trial data showed that 4-weeks of E1-I.N.T. therapy (combination of gastrin analogue and epidermal growth factor analogue) in type 2 diabetes patients resulted in sustained reductions in blood glucose control parameters, including haemoglobinA1C, for 6 months post-treatment. These data suggest that gastrin plays an important role in beta cell differentiation and function, capable of providing sustained glucose control in type 2 diabetes. Transition has commenced the studies to advance its lead gastrin analogue, TT-223, formerly known as "G1", into Phase II clinical trials in type 2 diabetes patients.
To support the Phase II clinical development program for TT-223, Transition is currently performing Phase I studies to expand the dose ranges for TT-223. The first study, a single ascending dose study of TT-223 in healthy volunteers has completed dosing. The second study, a multiple ascending dose study of TT-223, is expected to begin later this year.
Transition expects to initiate the following Phase II clinical studies evaluating TT-223 in type 2 diabetes:
Transition will continue to work closely with the Juvenile Diabetes Research Foundation on development of TT-223 in combination with GLP-1 analogues for the treatment of type 1 diabetes. The clinical studies in type 1 diabetes patients will be disclosed at a later date.
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND-005/AZD-103 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates developed using its proprietary drug discovery engine. Transition'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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