It’s very interesting to hear that last contrasting point (obesity and the risk it presents society) that you made in terms of some of the biomarker development necessary is something less of a challenge than making a case about the importance of an anti-obesity drug and winning people over to its importance. Has there been a refining of those methods in terms of dealing with regulator attitudes in terms of making it less of an obstacle than it used to be?
Dr. Klassen: Well, no. I guess what I’m saying is in clinical trials, obviously for obesity you need to show weight loss and then you need to show what the ancillary improvements in other surrogate markers are that go along with that weight loss. Now, if your drug – your compound – happens to have a direct impact on some of these other markers or parameters beyond weight loss – which would be of interest – you’d need to clarify that mechanistically. But, for the most part the changes that we are talking about – the improvement in gylcemic control, reduction in inflammatory markers, impact on blood pressure, heart rate, lipid profiles, etc., all of those usually are just kind of part and parcel with the weight loss itself. So, what I meant is that it’s not as much of a challenge; it’s simply that you just measure that. So, there isn’t’ necessarily anything tricky about that paradigm.
I think what is more important is being able to appropriately put into context any of the theoretical risk in all drugs and all the three obesity compounds that we’re talking about have theoretical risks. The question is how that is offset with the potential benefits in many, many other disease states where therapies have been used and have been developed for longer periods of time. Again, depression is a great example.
We seem to know and value the benefit of treating depression. We appear today to know less and value less and certainly know less about the value of treating obesity, at least from a regulatory perspective. I don’t think the clinical community would believe that. I think the literature is quite clear on the benefits of even modest amounts of weight loss in the order of 4% or 5% reduction in body weight. It can have a dramatic improvement on a variety of metabolic parameters including the prevention of diabetes. But, from a regulatory perspective codifying what that benefit really means and, therefore, what level theoretical risk for any compound you are willing to accept. That is something that still feels like it is being sorted out.
To find out more about the Innovation and Commercialization of Therapeutics for Metabolic Disorders, download the agenda. If you'd like to join us this January 11-12, 2013 in Baltimore, Maryland, register today and mention code XP1803BLOG to save 15% off the standard rate!