EMIS: >Back in my drug delivery days quite a few years ago, I considered this company's science as highly suspect.<
>If you care to elaborate, I’m all ears. T.i.a.<
I swear this company has been trying to deliver peptides and proteins by oral route for about 15 years now. At that time they were focusibng on insulin, calcitonin and heparin and were delivering using these protenoid carriers (essentially protein hydrosylates). It was clearly black box approach in their presentations, where they would dose the peptide/protein in animals and just show some evidence of oral bioavailability. No explanation at all of mechanistic understanding or even a quantitative assessment of absolute oral bioavailability. Very frustrating from a technical assessment perspective. I have seen since then that they have progressed into clinical studies and have established parterships with Novartis and Roche, but even so, it seems progress has been slow. The biovailability improvement still does not appear that impressive and I believe they see some effect for insulin at 10 mg QID, but apparently the response is not that robust. Given their proposed mechanism for their carriers, it is not suprising they would see high variability given the dynamic nature of the carrier/protein interaction and the changing condtions of the GI environment, especially patient to patient, food effects, pH effects, etc. I remain skeptical.
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