Memorandum

Transition Therapeutics Pipeline Update – Reaffirms Lilly to begin phase 2 dosing of GLP-1/glucagon dual agonist in 2Q14 – April 8, 2014

Executive Highlights

  • Lilly is performing final preparation for its phase 2 trial of it/Transition’s GLP-1/glucagon-dual agonist TT401; dosing is expected to begin in 2Q14.
  • One trial listed on ClinicalTrials.gov might be of TT401 (potentially renamed LY3053102).

Yesterday, Transition Therapeutics held a call to update investors on its pipeline – listen to the call here. Though the majority of the call centered on Transition’s neuropsychiatric pipeline, notably, Transition CEO Dr. Tony Cruz also noted that Lilly is performing final preparation for its phase 2 trial of Lilly/Transition’s GLP-1/glucagon-dual agonist TT401. In line with earlier timelines provide by Transition, management indicated that dosing is expected to begin in 2Q14. We had not heard a public timeline from Lilly on when this trial is to begin; in a conversation we had with Lilly management earlier this year, management had said, more conservatively, that it was not specifying a timeline at that time so this was great news as presumably Lilly management concurs on the timing.

ClinicalTrials.gov indicates that Lilly has one phase 1/2 trial recruiting of LY3053102 in people with type 2 diabetes, which might be TT401 renamed. We have not heard what LY3053102; however, it is possible that it is TT401, as the profiles indicate LY3053102 is injected (as a GLP-1/glucagon-dual agonist would be). The trial is six-month long and (12-week treatment period) is expected to end in September 2015, and compares LY3053102 to exenatide extended release (AZ’s Bydureon) and placebo (n=375; ClinicalTrials.gov Identifier: NCT02020616). We have not heard from Lilly yet whether LY305102 is in fact TT401.

As background, last summer, Lilly exercised its option and licensed TT401, at which time Transition received a $7 million milestone. Lilly is responsible for internally developing TT401 and commercializing it, as well as all associated costs. Transition is to pay Lilly $14 million in three installments during the 2014 calendar year. Lilly has another GLP-1/glucagon dual agonist in phase 1 development, oxyntomodulin. Zealand is also working on GLP-1/glucagon dual agonists, both on its own (ZP2929; phase 1) and in collaboration with BI (undisclosed).

 

--by Hannah Deming and Kelly Close