Lilly considers taking the plunge on a next-gen GLP-1 drug for diabetes

Canada's Transition Therapeutics ($TTHI) is touting positive Phase II data for a once-a-week GLP-1 treatment, triggering a decision point for partner Eli Lilly ($LLY), which bought into the program in a $247 million deal.

The treatment, TT401 is a dual-acting agent for Type 2 diabetes, boosting both the body's GLP-1 receptors--much like Lilly's Trulicity--as well as its glucagon receptors with a double mechanism Transition says can help curb appetite while controlling blood glucose.

In a 12-week study on 420 diabetics, Lilly and Transition tested four dosages of TT401 against AstraZeneca's ($AZN) GLP-1 drug Bydureon and placebo. TT401 demonstrated blood sugar improvements similar to--but not better than--Bydureon, Transition said, and beat out placebo by a statistically significant margin on that measure.

The highest dose of TT401, 50mg, made a significant difference in weight loss compared with AstraZeneca's treatment and placebo, according to the company, and safety was comparable between the TT401 and Bydureon arms.

Now it's up to Lilly whether to take TT401 into Phase III. Lilly licensed the treatment in 2013, paying $7 million up front and promising up to $240 million more if TT401 makes it to market. If Lilly decides to pass on the drug, Transition has the option of moving forward on its own or finding a new partner, the company said.

Lilly will have to decide whether TT401's purported benefits can differentiate it in a fast-crowding space. Trulicity won approval in 2014, contending with Novo Nordisk's ($NVO) market-leading GLP-1 drug Victoza, which is dosed daily. Since then, Novo has embarked on a 6-trial effort to support semaglutide, its own weekly GLP-1 treatment, and rival therapies from GlaxoSmithKline ($GSK) and Sanofi ($SNY) have won approvals around the world.

Lilly didn't respond to a request for comment on the TT401 program Monday.

The two companies have been collaborating for nearly a decade with little clinical success. Lilly licensed TT-223, another diabetes drug, in 2008 but discarded the program two years later after a trial failure. The same came of TT-701, a Lilly-licensed treatment for arthritis pain that never made it past Phase I. The two are now working together on TT701, a Phase II drug designed to boost muscle mass.

- read the statement