Recently, Transition Therapeutics Inc. (TTHI) suffered a pipeline setback when it decided to discontinue the development of its type-II diabetes candidate, TT-223, following the disappointing performance of the candidate in a placebo-controlled study (n~150).
The randomized, double-blind study evaluated the safety, tolerability and efficacy of TT-223 (given daily) in conjunction with Eli Lilly’s (LLY) glucagon-like peptide-1 (GLP-1) analogue administered weekly. TT-223 did not prove to be effective when tested as a combination therapy with Eli Lilly’s diabetes treatment for 4 weeks. The study had a 5-month follow-up period.
We remind investors that Transition Therapeutics announced a licensing and collaboration deal with Eli Lilly in March 2010, whereby it acquired the rights to multiple preclinical diabetes compounds from Lilly. Under the terms of the deal, Transition Therapeutics acquired exclusive global rights to develop and commercialize diabetes compounds which had performed impressively in preclinical studies. The failure of TT-223 will not have any impact on this deal.
TT-223 refers to a gastrin analogue which was being developed to treat patients suffering from type II diabetes. Gastrin, produced by special cells in the stomach, is a hormone found in humans that regulates the secretion of acid in the stomach.
This setback comes close on the heels of the disappointing results on its lead candidate ELND005, co-developed with Irish company Elan Corporation (ELN), in a mid-stage study (AD201). The study (n=351) evaluated the candidate in patients suffering from mild to moderate Alzheimer’s disease. The disease, a progressive disorder of the brain, is a leading cause of dementia. Apart from these two candidates, the other pipeline candidates at Transition Therapeutics target anti-inflammatory and metabolic diseases.
Currently we have a Zacks# 2 Rank (Buy) on Transition Therapeutics (founded in 1987 and headquartered in Toronto) based on its diverse pipeline and agreements with big players like Lilly and Elan. However, we prefer to remain on the sidelines in the long-run with a Neutral view on the stock.