XenoPort, Inc. (XNPT)
Q3 2012 Earnings Call
October 24, 2012 5:00 p.m. ET
Ron Barrett – CEO
Bill Harris – Vice President, Finance and CFO
Vince Angotti – COO
Jackie Cossmon – Investor Relations
Michael Yee – RBC Capital Markets
Brian Abrahams – Wells Fargo Securities
Marko Kozul - Leerink Swann
David Amsellem - Piper Jaffray
Juan Sanchez - Ladenburg Thalman
David Friedman – Morgan Stanley
Imran Babar - Cowen & Co.
Previous Statements by XNPT
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» XenoPort's CEO Presents at Morgan Stanley Global Healthcare Conference (Transcript)
» XenoPort Management Discusses at Wedbush Securities Conference - Conference Call Transcript
» Xenoport's CEO Discusses Q2 2012 Results - Earnings Call Transcript
Ms. Cossmon. You may begin your conference.
Thank you, Brian. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Harris, our Vice President of Finance and Chief Financial Officer; and Vince Angotti, our Chief Operating 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 relating to the future sales of and promotional activities for gabapentin enacarbil, our current and future clinical development programs and clinical trials, the release of additional clinical trial data and the timing thereof, potential advantages of our product candidates, our dependence on collaborative partners 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 Factor 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. Thank you all for joining us on the call today. I’d like to begin today’s call with an update on our business progress and then I will turn it over to Bill who will briefly discuss our financial results for the quarter. We’ll then take your questions.
One highlight for the quarter was the results of our first phase 1 trial for XP23829 which I will refer to as 829. Since early October, we’ve had a chance to review the data with experts in the treatment of multiple sclerosis and psoriasis. The feedback has been encouraging.
We continue to believe in the potential of 829 to be better tolerated than other fumaric acid ester based products. One interesting question that has arisen in our discussions with experts is whether the efficacy of FUMADERM and/or BG-12 in psoriasis and/or MS could be improved upon. A better tolerated MMF pro-drug may allow testing of higher MMF levels.
Alternatively an appropriately formulated MMF pro-drug that provided sustained MMF levels above a required threshold for a longer duration of time may provide improved efficacy. We believe that the formulation of 829 that we identified in our phase 1 study could provide the tools to address these questions of potential differentiation in terms of tolerability and efficacy.
We are busy finalizing the plans for the next studies for 829. One study will be a dose escalation multiple dose phase 1 trial in healthy subjects, designed to further establish the safety, tolerability and pharmacokinetics of 829. We plan to take both the formulations of 1 and 2 into the study. We expect it will be -- there will be approximately 75 subjects and if all goes as planned, we would anticipate the results from this trial by mid next year.
We are also planning to conduct a drug metabolism disposition study with radio labelled 829 in healthy subjects. The goal of the study will be to fully characterize and quantitate the metabolites of 829 and how they are eliminated from the body. We hope to be able to demonstrate to regulatory authorities that any metabolites of 829 in humans have been adequately studied in our animal tox studies. This study is planned to commence in the first half of 2013.
Another action we’ve taken to advance the 829 program is to initiate 13-week animal tox studies to support human studies of longer duration. We would expect to have preliminary results of these studies by mid-year next year. We continue to explore the opportunities for developing 829 as potential treatment for relapsing and remitting multiple sclerosis and as a potential treatment for psoriasis.
In addition, in collaboration with The Michael J. Fox Foundation we’re looking at 829 in an experimental pre-clinical model progression in Parkinson’s disease. I will remind you that we have an issued composition of meta patent in the U.S. which extends into at least 2029. In our thinking about how to best develop 829, we’re carefully considering the potential sequencing of indications during the product’s lifecycle.
I’d like to turn now to AP, arbaclofen placarbil. We’re nearing completion of enrollment in the phase 3 efficacy trial in MS patients with spasticity. After being randomized subjects are in the study for 12 weeks. We expect to randomize less subjects in the next few weeks. With the customary time for data checking and statistical analysis, our best estimate is that we will be reporting preliminary top line results in early in Q2 2013. This is somewhat later than the Q1 estimate we last provided and has been driven by the slower enrollment we experienced in July and August which failed to revamp to the extent we thought it might in September.