April 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TORONTO – Eli Lilly (LLY) has opted to not advance a diabetes drug into a Phase III clinical trial it was developing in coordination with Canada-based Transition Therapeutics Inc. (TTH.TO), the companies announced today.
News of Eli Lilly’s withdrawal of support for Transition’s drug sent that company’s stock plummeting nearly 20 percent. The stock is currently trading at $1 per share, down from its closing price of $1.24 per share on Friday.
Development and possible commercialization of the experimental drug, TT401, will now rest solely with Transition Therapeutics. Lilly chose not to continue in the advancement of TT401 because the experimental drug did not demonstrate a significant advantage in lowering HbA1c, glycated hemoglobin, Seeking Alpha noted.
TT401 is a once-weekly administered oxyntomodulin analog, with dual agonist activity on the GLP1 and Glucagon receptors. 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 II 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, AstraZeneca (AZN)’s Bydureon, and placebo after 12 and 24 weeks of treatment, Transition said in a statement. 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, according to data supplied by Transition.
Under terms of the agreement the two companies had, Eli Lilly will still be eligible to receive a royalty on future TT401 sales and a royalty on TT401 non-royalty income. Any royalty that Transition is eligible to receive on sales of related Lilly compounds remains unaffected, Transition said in announcing the termination of the Eli Lilly deal.
GLP-1-based drugs are manufactured by a number of companies, including Danish-based Novo Nordisk (NVO). Novo Nordisk manufactures several GLP-1 diabetes treatments, including Victoza, which is marketed under the brand name Saxend in the United States. In April, Novo Nordisk announced its Saxend, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults, was available for sale in the United States. Obese individuals often develop type 2 diabetes. Eli Lilly has its own GLP-1 based drug, Trulicity, which was approved by the U.S. Food and Drug Administration in 2014 for the treatment of type 2 diabetes.
Tony Cruz, chairman and chief executive officer of Transition, said TT401 offers the company a unique opportunity to develop a “first-to-market” product with a “differentiated mechanism and activity from currently approved diabetes therapeutics.”