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2009 Pre-ADA Report
May 28, 2009
While this year’s conference lacks groundbreaking data on new drug classes, there will be important new clinical data to help define the competitive profile for a number of compounds.
For long-acting GLP-1 agonists, Lilly’s GLP-Fc and GSK’s Syncria will present their first significant A1C data, though the fate of this class of drugs rests on how the FDA will handle the issue of preclinical thyroid medullary cancer in the Victoza NDA. Byetta will have more claims database results on pancreatitis, an issue impacting its marketing.
There will also be first longer-term (12 week) data for a couple DPP-IV inhibitors, namely Boehringer’s Ondero, in line to be the third to the market, and Pfizer’s PF-00734200. There are a large number of DPP-IV inhibitors in development, and marketed Januvia has a good tolerability profile, so it will be interesting to see whether any data serves to differentiate these drugs.
GSK’s SGLT2 inhibitor remogliflozin will present its first human dose escalation pharmacokinetic/pharmacodynamic data. While remogliflozin is only the second SGLT2 inhibitor to present such clinical data, there are a number of these agents in Phase II development, and Boehringer’s BI 10773 should complete a Phase IIb trial later in the year.
Roche will present Phase II data on PPAR alpha/gamma agonist aleglitazar and announce whether the drug will proceed to Phase III. If the drug does advance, that will be a major step, since such agents have been plagued with safety issues that derailed a couple prominent late-stage drugs.
Finally, there are agents with novel mechanisms -- involving the enzyme 11beta-HSD1, the GPR119 receptor, the cytokine IL-1 beta, and the FXR receptor -- that will have early stage data.
The conference data are still embargoed, but we have highlighted what we think are the most relevant clinical studies. We have also included a list of other pertinent talks and posters.
For the full report, please download the PDF version at the top of this page.
For our disclosures, please read the BioMedTracker Research Standards.