The FierceBiotech team tackled coverage of drug-development news and events at the American Diabetes Association annual meeting in Chicago, where I met with leaders in the field and, as a matter of survival, hid my allegiance to the Boston Bruins. Our coverage here will last through Monday, so look for more ADA news over the next 24 hours or so on our website.
We're put together snippets from the top ADA stories over the weekend with links to the full articles below. If you haven't done so already, please open the special ADA issue we sent to your inbox early this morning.
Sanofi spotlights new PhIII diabetes data for son of Lantus
CHICAGO--Sanofi ($SNY) has provided the first glimpse at Phase III data for new insulin glargine, which is a next-generation version of its top-selling diabetes drug Lantus. Hoping to ease regulators' concerns about the potential side effects of a new diabetes drug, the late-stage trial shows that the next-gen drug could be safer than Lantus in patients with Type 2 diabetes. In the debut of the study data here at the annual meeting of the American Diabetes Association, Sanofi said that the experimental insulin, dubbed U300, showed equal ability to keep blood sugar levels under control as Lantus, meeting the study's main goal of noninferiority to the marketed drug. Story
Boehringer, Lilly tout PhIII results for another SGLT2 drug
CHIGAGO--Diabetes partners Boehringer Ingelheim and Eli Lilly ($LLY) revealed that their SGLT2 diabetes drug empagliflozin held its own in a slate of Phase III trials, yet the available clinical data make it difficult to show how the experimental treatment stands out from the rest of the drugs in the same class. At the American Diabetes Association's annual meeting, major players in the diabetes market have been highlighting data on their SGLT2 inhibitors, which trigger the exit of glucose out of the body via urine, working separately from insulin. Germany-based Boehringer has shed light on an analysis from four Phase III studies of empagliflozin, showing that the drug provided significant reductions in average blood glucose, blood pressure and body weight. On the safety side, the data show that patients on the drug had a greater chance of having genital infections, a side effect that is likely to come up again during regulatory reviews. News
Zafgen's obesity drug drives dramatic weight loss in PhII test
CHICAGO--Zafgen has revealed some impressive weight-loss data from a midstage study of its experimental therapy beloranib, highlighting interim results after 12 weeks of treatment in 19 obese white women. In that relatively small and homogeneous group, there were signs of significant drops in weight without changes in diet and exercise for those on the drug. Cambridge, MA-based Zafgen, which plans to present the data on Sunday at the annual American Diabetes Association (ADA) meeting, reported that the treatment provided up to 10 kilograms, or 22 pounds, of weight loss. The company expects to report full data from the 148-patient study later this summer. Article
Biotech startup Elcelyx scores upbeat diabetes data on reinvented metformin
CHICAGO--Elcelyx Therapeutics has debuted midstage data for its lead diabetes drug candidate, a delayed-release version of the old warhorse metformin. With the data being presented Sunday at the American Diabetes Association annual meeting, the San Diego startup also aims to upend beliefs about how metformin works. About 4 million diabetics in the U.S. have kidney problems and aren't supposed to take metformin, a first-line and foundational treatment for Type 2 diabetes, because of the lactic acidosis that the drug can trigger after it enters the bloodstream. Elcelyx's formulation of metformin, called NewMet, is designed to deliver metformin at the lower bowel, where active drug acts on enteroendocrine cells. This way less metformin hits the bloodstream, potentially making the treatment available to millions of diabetics with renal impairment. Article
In big PhIII showdown, Eli Lilly's dulaglutide bests Byetta and Januvia
CHICAGO--With big hopes for its diabetes business, Eli Lilly ($LLY) has highlighted upbeat data from three late-stage studies of its experimental drug dulaglutide showing that the drug provided better blood-sugar control than Bristol-Myers Squibb's ($BMY) Byetta, Merck's ($MRK) Januvia and metformin. The drug giant aims to seek FDA approval of the once-weekly therapy later this year--making this treatment a critical exhibit in the pharma giant's case that it can turn around the fortunes of its R&D division. Lilly has delivered some badly needed clinical trials success with dulaglutide after a series of pipeline pratfalls for experimental Alzheimer's disease and rheumatoid arthritis drugs over the past year. The company is banking on new diabetes drugs such as dulaglutide to sustain sales as the old cash cows Zyprexa and Cymbalta fade in the face of generic-drug competition. The dulaglutide data were revealed today at the annual American Diabetes Association meeting. Article
Novo Nordisk's R&D chief sizes up diabetes rivals and scandal-wary FDA
|Mads Krogsgaard Thomsen|
CHICAGO--Novo Nordisk ($NVO) has begun to regroup from one of the biggest regulatory setbacks of the year. In February the FDA dealt the Danish drugmaker a major blow in denying approval of its blockbuster hopeful, Tresiba, seeking cardiovascular outcomes data on the long-acting insulin that will delay the U.S. launch of the drug by several years. The rejection reaffirmed the agency's earned squeamishness about any signal of cardio dangers from diabetes drugs and gave Novo Nordisk's archrival Sanofi ($SNY) a reprieve from U.S. competition to its own long-acting insulin Lantus. In fact, Sanofi has a shot to introduce a next-gen version of Lantus called U300 on the U.S. market before Tresiba ever arrives here. The gnarly Tresiba situation makes Mads Krogsgaard Thomsen, Novo's chief of R&D, an interesting source of views on the safety requirements on diabetes drugs from the FDA and the rabid competition his company faces in the diabetes field. More >>
-- Ryan McBride (email | Twitter)