GLP-1 drugs have long been one of the hottest targets in diabetes R&D, attracting the attention of the all of the giants that play in this blockbuster market. But now Roche ($RHHBY) has its eye on an early-stage program that could do GLP-1 drugs one better.
Investigators working with Roche are keenly interested in a new program that combines a GLP-1 drug--which is designed to mirror the effect of a natural hormone on diabetes and obesity--with another hormone imitator, GIP, into a new molecular structure. In a brief early-stage trial of 53 patients with Type 2 diabetes scientists say they picked up some clear signals of a "synergistic" effect, indicating that they had a drug that potentially could be used one day at lower doses with a greater impact on the disease.
The co-agonists spur an improvement in blood sugar, weight loss and lower blood fat, offering a potential breakthrough approach.
"Our results give us additional confidence that our combinatorial approach of modulating brain regulatory centers via natural gut hormone signals has superior potential for a transformative diabetes treatment," explains Matthias Tschöp, an investigator at the Institute for Diabetes and Obesity at the Helmholtz Zentrum in Munich. "Still, this approach has to go through several more years of intense research, clinical testing, and safety evaluations, before these substances may become available for patients."
"We are using mother nature's toolkit and we're hoping to find the right combination that will produce a breakthrough," Tschöp told Reuters. "I believe a combination of things will be necessary to reach the efficacy and power to really cure and prevent Type 2 diabetes and obesity."
While some R&D fields have been blazing shorter trails through the clinic, though, diabetes seems to just get tougher and tougher for developers. The FDA emphatically raised the safety bar on diabetes therapies several years ago. And some big players have responded by expanding studies and tackling head-to-head trials long before moving for a market approval.
Nowhere is that tougher standard more evident than in new programs for GLP-1 drugs. Anxious to capitalize on a new field as pioneers like Novo Nordisk ($NVO) and Bristol-Myers Squibb ($BMY) pursue growing sales, companies like Eli Lilly ($LLY) are ambitiously following up on their own top prospects. For Lilly that has required an expensive set of studies to prove that dulaglutide should be considered a first-in-class drug.
Now Roche is setting up a program that could eventually steal a march on all the players. In drug development, the bigger the commercial goal, the greater the clinical effort. And there are few markets that rival diabetes.
- here's the press release
- here's the Reuters feature
Special Report: Top diabetes drug pipelines of 2012