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XenoPort, Inc. (XNPT)
Q3 2008 Earnings Call Transcript
November 5, 2008, 5:00 pm ET
Jackie Cossmon – IR
Ron Barrett – Chief Executive Officer
Bill Harris – SVP, Finance and CFO
Bill Rieflin – President
Rachel McMinn – Cowen & Company
Steve Harr – Morgan Stanley
Ram Selvaraju – Rodman & Renshaw
Michael Yee – RBC Capital Markets
Lucy Lu – Citigroup
Davis Bu – Goldman Sachs
Katherine Xu – Credit Suisse
Gene Mack – Lazard Capital Markets
Yale Jen – Maxim Group
Greg Wade – Pacific Growth
Previous Statements by XNPT
» XenoPort, Inc. Q2 2009 Earnings Call Transcript
» XenoPort, Inc., Q1 2009 Earnings Call Transcript.
» XenoPort Inc. Q4 2008 Earnings Call Transcript
Thank you, Robert. Good afternoon, and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Rieflin, our President; 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 in this conference call and webcast, including answers to questions 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 clinical trials and the timing thereof, our partners' clinical development plans, the release of additional clinical trial data, future regulatory submissions and the timing thereof, and the commercial potential for 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 filing, including our discussion of the inherent risks of clinical trials. This webcast is a copyright of XenoPort.
At this time, I would like to turn the presentation over to Ron.
Thank you, Jackie, and thank you all for joining us on today's call. I'll be speaking today about our clinical development programs, and Bill Harris will spend a few minutes discussing our financial results for the third quarter. We will then take your questions.
As outlined in our press release, there has been significant activity with our development program since the start of the third quarter. Let me start with the disappointing news regarding the Astellas Phase 2 clinical trial of 512 in painful diabetic neuropathy patients in Japan.
This was an eight-week trial conducted in Japan that examined placebo and three doses of 512. The primary endpoint was the change from baseline in pain score rated on a zero to ten scale. The trial included an interim analysis conducted by an independent data review committee, the purpose of which was to recalculate the powering requirements for demonstrating efficacy in the trial while maintaining blinding of the data. The interim analysis indicated that the number of required subjects would be prohibitive, and Astellas decided to terminate the trial. The interim analysis also indicated that 512 was generally well tolerated with no safety concerns.
We are working with Astellas to fully understand these results. From the preliminary analysis, it appears that the baseline pain scores in this Japanese PDN population were at the low end of the range compared to scores in studies conducted in the US and Europe. In addition, the preliminary analysis indicated a high placebo response. These factors may have contributed to the inability to distinguish 512 from placebo, but there may be other factors.
I should point out that there have been no published PDN studies using pain as an endpoint conducted in Japan, so we don't have access to other data against which to compare these results. Astellas will make a decision about whether to continue the development for PDN in Japan after XenoPort and Astellas have reviewed all the data and consulted with experts. It is possible that Astellas could conclude that further investment in PDN in their territory is not warranted.
I'd like to emphasize that 512 is the subject of a broad development program. In mid-September, GSK filed an NDA with the FDA for Solzira for the treatment of RLS based on the full development program conducted by XenoPort. We believe that Solzira holds the potential to be an important alternative to dopamine agonists as a treatment for RLS.
Our clinical trials in RLS patients indicate a number of potential benefits of Solzira treatment. For example, later this week we will be presenting a poster at the International Conference of the Mechanism and Treatment of Neuropathic Pain, demonstrating the positive effects of 512 on pain associated with RLS symptoms in one of our 12-week RLS trials.
We've also shown that 512 treatment may provide RLS patients with important sleep benefits. GSK has recently initiated a Phase 3B polysonography trial to further study potential sleep benefits in RLS patients. In addition, Astellas has recently completed enrollment of a Phase 2 study of 512 in RLS patients in Japan.
Beyond RLS, GSK is studying Solzira in three Phase 2 neuropathic pain studies, including a PDN study that recently completed enrollment. GSK has advised us that the results from the Astellas PDN clinical trial will not impact the GSK neuropathic pain development program. We look forward to the results of the three ongoing GSK studies in neuropathic pain in 2009.