Question-and-Answer Session
Operator
Thank you. (Operator Instructions). Your first question comes from the line of Mark Monane representing Needham & Company. Please proceed.
Mark Monane - Needham & Company
Hey, thank you. Good afternoon and thanks for taking my call. Congratulations on your progress so far.
Gordon Brandt
Thanks Mark.
Mark Monane - Needham & Company
With respect to progress, could you outline for us what’s the great learning step on the P&G program, the PTH. Is the biomarker data necessary for moving a trial forward, are there other limitations there, and what would be the rate limits there for starting a Phase 3 trial here?
Gordon Brandt
Thanks Mark, this is Gordon Brandt. I am sure you will appreciate that it's difficult for us to comment more. We are obviously working closely with our partners Procter & Gamble, and they are really controlling the information flow on this program for commercial and scientific reasons.
So as we said last year, biomarker studies are starting, then studies with an additional endpoint will follow thereafter, and those would be expected to model the Phase 3 studies. So it’s an ongoing process, and we’re actively working on it, but unfortunately beyond that I am afraid I can’t share too much additional.
Mark Monane - Needham & Company
That’s fair. And in terms of the dose response curve for PYY program. We’ve heard that the curve for satiety goes from hunger satiety, nausea and vomiting, where if you have too high doses you start to get side effects; whereas smaller dose might give you the satiety without the nausea and the vomiting. For many of your earlier biomarker studies, is there any indication which dose might be the preferred dose at this point and how longer [guessing], of course this will influence how longer trial takes?
Gordon Brandt
Sure. The collected information that we have on PYY so far suggests a couple of things. Number one; whether it’s delivered IV or intranasal one gets the same kind of efficacy. Number two; each individual patient may have a different doze, which works best for them, and that’s why we have emphasized the doze optimization aspect of this study.
So again depending on what group you randomized to. If you get randomized to one of the higher doses of nasal PYY, you will be given a week at each of the lower doses to try to get accustomed to it. So, we've seen differences at least in the pharmacokinetic profiles, the amount of drug in the blood from one patient to the next, given the same dose, and so we want to give the patient an optimized dose for each individual person. I am not sure that that captures the answer to your question. Did you have a more specific question in mind?
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