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2010 Pre-ADA Report
June 21, 2010
One of the most highly anticipated sets of data had been details from the Phase III program for Roche's GLP-1 agonist taspoglutide. Unfortunately, a recent announcement of hypersensitivity reactions delaying the program has overshadowed these results, though it will still be useful to understand its profile versus Amylin's and Lilly's Bydureon in case an alterable cause for the hypersensitivity can be found.
Also eagerly awaited are results from Novo Nordisk's long-acting insulin Degludec, with Phase II studies versus Lantus. Degludec has a relatively flat pharmacokinetic profile with less variability, so it will be interesting to see whether this gives any benefit in the tradeoff between efficacy and hypoglycemia.
In the DPP-IV inhibitor segment, Boehringer's Ondero will have first details presented from its Phase III program, though thus far, the DPP-IV inhibitors have had difficulty differentiating themselves from Merck's Januvia on efficacy or safety. Another DPP-IV inhibitor, Takeda's alogliptin, will present a summary of cardiovascular events from its clinical trials, which will be revealing because it did not meet the FDA's newly required cardiovascular screening guidelines, and hence will need data from a dedicated cardiovascular trial.
The SGLT2 inhibitors are a promising class, with possibly better efficacy and more weight loss than the DPP-IV inhibitors, though they have a higher incidence of genito-urinary infections. They have the potential to work across the full spectrum of patients, and to demonstrate this, Bristol-Myers' and AstraZeneca's Dapagliflozin will have Phase III data from a study where it was added on to insulin. The second SGLT2 inhibitor in Phase III development, JNJ's Canagliflozin, will present its first efficacy data (with a Januvia comparator), as will Boehringer's BI 10773, though from an early stage study. Finally, Lexicon's LX4211, will have updated data from its strong, albeit small, Phase IIa study.
While most of the data for obesity drugs at the ADA is incremental, this will be a crucial year for the future of these therapeutics, with advisory committee meetings and PDUFAs for several drugs over the next 7 months. Hence it will be interesting to gauge interest for these drugs among diabetes physicians.
We also note in this report early stage data from drugs with interesting mechanisms, including GPR119 agonism, GPR40 agonism, microsomal triglyceride transfer protein (MTP) inhibition (from a drug that is not absorbed, in order to avoid systemic toxicities), partial A1 adenosine agonism, PTP-1B inhibition, and for obesity, preclinical data on methionine aminopeptidase 2 inhibition.
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