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Transition Therapeutics, Inc.

Partner : ELi Lilly

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Dr. Tony Cruz, Chief Executive Officer, gave guidance for next steps with the TT401 asset. He stated, "Transition is going to perform, once we receive the data, an in-depth post-hoc analysis of the data to better understand the weight loss in these diabetes patients. This may be helpful in designing future studies. In the interim, the company is awaiting notice from Lilly on their decision to continue development or transfer all rights to TT-401 to Transition. Lilly is expected to do this within the next 90 days. Should Lilly continue TT-401 development, then Transition would be eligible to receive $15 million milestone as well as future milestone payments and royalties. Otherwise, Transition may elect to assume development and commercialization rights, and the option will be to pursue development on its own or with a third-party, subject to future royalties to Lilly as well."
Source: Q2 FY 2016 earnings conference call, 2/09/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
TT-401 (LY2944876)Endocrine and MetabolismDiabetes type IIGLP-1 and glucagon receptor agonistGLP-1 and glucagon receptors

Mechanism of action: TT-401 (LY2944876) is an oxyntomodulin analog that has dual agonist activity of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors.

Phase of Development: II

Event Type: Corporate: Partnership and development decision

Dates: 2016-02-01 - 2016-05-31

Results:

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Transition Therapeutics Provides Update on Type 2 Diabetes Drug Candidate TT401 TORONTO, ON, March 18, 2016 – 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.
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Source: press elease, 4/18/16. http://www.transitiontherapeutics.com/media/press_releases/20160418.pdf

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