Summary
The 3-month reduction in HbA1c demonstrated by AGI-1067 is promising, but I still have many questions regarding the design and outcomes. There are many existing therapies that lower A1c - many have undesireable side effects like weight gain or hepatotoxicity.
Analysis
Lowering HbA1c by 0.5% at the highest dose makes for a good press release, but what was the starting level? There's a big difference between patients starting at 9.5% and those at 7.5%.
Also, I am troubled by the elevated liver enzyme results, even if they are sporadic. The most scary liver toxicities are those that are difficult to predict from a population genotype/phenotype standpoint. DPP-IV inhibitors like Januvia lower A1c by as much as 1.0% and don't appear to be hepatotoxic or cause weight gain. How will AGI-1067 compete with these?



