XenoPort Announces Advancements in Clinical Development Programs
- Category: Small Molecules
- Published on Tuesday, 09 January 2007 02:00
- Hits: 2658
SANTA CLARA, CA, USA | Jan 08, 2007 | XenoPort, Inc. (Nasdaq:XNPT) announced today that it will report several developments in its XP19986 and XP13512 clinical programs at the JPMorgan 25th Annual Healthcare Meeting. These advancements include identification of a new tablet formulation for XP19986 that may be suitable as a once-a-day treatment for gastroesophageal reflux disease, or GERD, as well as updates on clinical trials that are part of XenoPort's XP13512 development program.
In a single-dose Phase 1 clinical trial, XenoPort evaluated different sustained-release tablet formulations of XP19986. All formulations provided good absorption of XP19986 and conversion to R-baclofen. One formulation demonstrated a pharmacokinetic profile similar to the prototype capsule formulation used in previous studies, and a second formulation provided a pharmacokinetic profile that may allow once-a-day dosing of XP19986. XenoPort plans to conduct an additional Phase 1 escalating repeat-dose clinical trial of the potential once-a-day formulation in healthy subjects prior to initiating a Phase 2 clinical trial in patients with GERD in the second half of this year.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "We are very pleased with the early results with the new formulations of XP19986. While we believe that patients would accept twice-a-day dosing for the treatment of GERD, the new once-a-day formulation might further enhance the therapeutic utility of, and commercial opportunities for, XP19986."
XenoPort also indicated that it remains on track with its Phase 3 clinical program of XP13512 as a treatment for patients with restless legs syndrome, or RLS. XenoPort announced today that enrollment for study XP060 will be completed this week. XP060 is a Phase 3 trial that is designed to demonstrate the long-term maintenance of efficacy of XP13512 in the treatment of RLS patients. In October 2006, XenoPort announced the completion of enrollment of a 12-week Phase 3 clinical trial, XP052. A second 12-week Phase 3 clinical trial, XP053, was initiated in August 2006. Top-line results of study XP052 are targeted for release in the second quarter, with top-line results of study XP060 planned for the fourth quarter of this year. Top-line results of study XP053 are targeted for the second half of this year.
In addition to these Phase 3 efficacy trials, XenoPort is conducting additional clinical trials of XP13512 to further assess safety and tolerability. In a recent Phase 1 clinical trial of single doses of 2400, 3600, 4800 and 6000 mg of XP13512, XenoPort gained further evidence that XP13512 can provide higher exposure of gabapentin than that which has been previously reported for oral gabapentin itself. This property of XP13512 could afford advantages in the treatment of neuropathic pain conditions. A previously reported Phase 2a trial of XP13512 in post-herpetic neuralgia patients demonstrated that patients switched from oral gabapentin to XP13512 had higher gabapentin exposure and additional relief of pain. XenoPort plans to initiate a clinical trial of XP13512 in painful diabetic neuropathy, or PDN, in the second half of this year.
Dr. Barrett stated, "We have made extremely good progress in our clinical programs over the last year. We believe that these programs have the potential to provide significant patient benefits and represent substantial commercial opportunities. We are executing our plans based on the priorities of advancing our XP13512 Phase 3 RLS program, adding another indication, PDN, to the XP13512 program and moving XP19986 forward in the GERD indication this year. We also plan to file an IND and initiate a Phase 1 clinical trial on our third clinical development candidate, XP21279, in the second half of this year."
XenoPort will present its progress and clinical development plans at the JPMorgan 25th Annual Healthcare Conference on Wednesday morning, January 10, 2007, at 8:00 a.m. Pacific Time. To access the live presentation via the web, please go to www.XenoPort.com or to https://events.jpmorgan.com. The XenoPort presentation can be accessed through the "Conference Webcasts" link for the JPMorgan Annual Healthcare Conference. Please connect to the website at least 15 minutes prior to the live presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.
A replay of the webcast can be accessed for a minimum of one week and will be available approximately 24 hours after the live presentation.
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort's most advanced product candidate, XP13512, is the subject of a Phase 3 clinical program for the treatment of RLS, and has successfully completed a Phase 2a clinical trial for the management of post-herpetic neuralgia. XenoPort has also reported positive results of a Phase 2a clinical trial of its second product candidate, XP19986, in patients with GERD.
To learn more about XenoPort, please visit the web site at www.XenoPort.com.
This press release contains "forward-looking" statements, including, without limitation, all statements related to our future clinical development program for XP13512, XP19986 and XP21279 and the timing thereof; the therapeutic and commercial potential of XP13512 and XP19986; the suitability of XP19986 as a treatment for GERD; future clinical development plans; and our future clinical trials. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "targeted" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon XenoPort's current expectations. Forward-looking statements involve risks and uncertainties. XenoPort's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability of the company to successfully conduct the clinical trials for XP13512 and XP19986; the uncertainty of the FDA approval process and other regulatory requirements; and the therapeutic and commercial value of the company's compounds. These and other risk factors are discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed with the Securities and Exchange Commission on November 3, 2006. XenoPort expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
XenoPort is a registered U.S. trademark.
Source code: XNPT2C
SOURCE: XenoPort, Inc