XenoPort, Inc. (XNPT)
XenoPort XP23829 Clinical Trial Results Call
October 04, 2012 04:30 pm ET
Jackie Cossmon - Investor Relations
Ron Barrett - Chief Executive Officer and Director
Bill Harris - Senior Vice President of Finance and Chief Financial Officer
Michael Yee - RBC Capital Markets
Brian Abrahams - Wells Fargo
David Amsellem - Piper Jaffray
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Thank you, Kirk. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer and Bill Harris, our Senior Vice President of Finance and Chief Financial Officer.
Before we begin our discussion of today's news, I would like to note that the information to be discussed on this conference call and webcast, including answers to questions asked during this call will include forward-looking statements that involve risks and uncertainties, including statements related to our current and future clinical development programs and the timing thereof, future clinical trials, potential advantages of our product candidates and the therapeutic and commercial potential of our product candidates. XenoPort can give no assurance with respect to these statements and we assume no obligation to update them.
For detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by or anticipated in these forward-looking statements, please refer to the Risk Factors section of our most recent SEC filings, including our discussion of the inherent risks of clinical trials and regulatory matters. This webcast is a copyright of XenoPort.
At this time, I would like to turn the presentation over to Ron.
Thanks, Jackie. By now you have seen our press release announcing preliminary results from the Phase 1 trial in healthy adults designed to assess the pharmacokinetics, safety and tolerability of single doses of four different formulations of XP23829, which I will refer to as 829.
We are obviously pleased with the results. However I want to remind everyone that this study was done with a low single dose of 829 and a small number of healthy subjects. More work is needed to fully characterize the pharmacokinetics and tolerability profile of 829, particularly relative to other fumaric acid ester-based products. The data from this first in human trial obviously support continued advancement of this program. I'll discuss our next steps after I review the data from the study.
The press release gives the basics of the study design, so I won't repeat it here. Our focus on the major results of the study. First, 829 was metabolized to monomethyl fumarate in humans the way we intended. Second, we created different MMF PK profiles using different formulations, so we believe we can potentially mimic FUMADERM or BG-12 PK profiles or create other MMF profiles. One of our formulations appears to be worthy of further evaluation for potential once a day dosing with the potential added benefit of minimal food effect. And third, we obtained some preliminary insight into the potential relationship between MMF pharmacokinetics and flushing.
So, taking these one at a time, the trial showed that 829 was metabolized in human similar to the way it was metabolized in animal species, we've used in our pre-clinical work. After dosing of 829 in humans, we observed MMF in blood while the levels of the IMTEC prodrug and the potential desmethyl-metabolite were below the detection limits. The promoiety in pharmacologically inactive molecule that is released in the enzymatic conversion of 829 to MMF was cleared rapidly with a half-life of around three hours.
The dose of 829 administered all subjects in the study was equivalent to 107 milligram equivalents of MMF, so why did we select this dose?
The reason is that it approximates the same number of MMF equivalence as are present in a single FUMADERM tablet or a single BG-12 capsule containing 120 milligrams of dimethyl-fumarate or DMF.
Like 829, DMF is a prodrug of MMF. In principle, one could compare our MMF exposures to data that have been published for these products. I am sure that some of you have going to want to do that. Let me tell you why you need to be careful. I'll start with a technical point about the way that we measure MMF and other analytes.
We use high sensitivity of [CIMA] aspect methods to simultaneous measure multiple analytes in whole blood samples. Some of the BG-12 PK studies that have been reported in posters determine MMF levels from plasma. There can be differences between levels measured in plasma and whole blood, so quantitative comparisons between studies should be done cautiously.
We are not aware of any published PK data on a single-dose of the BG-12 capsule containing 120 milligrams of DMF. Since we don't know that MMF exposure after BG-12 is dose proportional, simple downward extrapolation for published data at higher doses could be misleading. However, there is a published study for MMF PK whole blood after a single dose of FUMADERM containing 120 milligrams in DMF.
The references leech skins at our bridged trial of clinical pharmacology 2004, 58 page 429 if some of you want to look that up, however until we do direct comparative PK studies with FUMADERM and BG-12 at the same dose with the same subject with the same analytical method, we think this data in this publication is the best information with which to compare our results.