SANTA CLARA, Calif.--(BUSINESS WIRE)--May. 24, 2012-- XenoPort, Inc. (Nasdaq:XNPT) announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin clinical studies of XP23829 as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). Following clearance of the IND by the FDA, the first Phase 1 clinical trial to be conducted in healthy subjects will commence. This study is intended to examine the safety, tolerability and pharmacokinetics of XP23829, including confirmation of its conversion to monomethyl fumarate (MMF), and the performance of four novel formulations of XP23829 designed to have different drug release mechanisms and/or time profiles.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "We are pleased to take this step in advancing the development of XP23829. In addition to our filing the IND to initiate human clinical trials for the potential treatment of RRMS, we also recently demonstrated that XP23829 and related compounds were effective in an animal model of psoriasis. We are hopeful that our first Phase 1 clinical trial will provide evidence of safety and tolerability and also provide pharmacokinetic data that might support once-a-day dosing of XP23829. Our long-term goal is to create a best-in-class fumaric acid ester-based medicine for the potential treatment of RRMS and/or psoriasis."
XP23829 is a prodrug of MMF (also known as methyl hydrogen fumarate). In cell- and animal-based models, MMF has been shown to exhibit immuno-modulatory properties and inhibit damage from oxidative stress. In XenoPort's preclinical animal studies that compared molar equivalent doses of XP23829 to dimethyl fumarate (DMF), another prodrug of MMF, XP23829 demonstrated a greater degree of efficacy in animal models of both multiple sclerosis and psoriasis. Toxicology studies conducted in two species showed that XP23829 caused less stomach irritation compared to DMF.
XenoPort was awarded U.S. Patent 8,148,414 for "Prodrugs of Methyl Hydrogen Fumarate, Pharmaceutical Compositions Thereof, and Methods of Use." The patent is directed to the XP23829 compound and analogs and formulations thereof. The term of the patent runs until 2029, subject to potential patent term extensions under the Hatch-Waxman Act.
XenoPort is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders. Horizant® (gabapentin enacarbil) Extended-Release Tablets is XenoPort's first FDA-approved product. GlaxoSmithKline holds commercialization rights and certain development rights for Horizant in the United States. Regnite® (gabapentin enacarbil) Extended-Release Tablets is approved for the treatment of moderate-to-severe primary restless legs syndrome in Japan. Astellas Pharma Inc. holds all development and commercialization rights for Regnite in Japan and five other Asian countries. XenoPort holds all other world-wide rights and has co-promotion and certain development rights to gabapentin enacarbil in the United States. XenoPort's pipeline of product candidates includes potential treatments for patients with postherpetic neuralgia, spasticity and Parkinson's disease.
To learn more about XenoPort, please visit the company Website at http://www.XenoPort.com.
This press release contains "forward-looking" statements, including, without limitation, all statements related to patent coverage and term for XP23829; XenoPort's future clinical trials and the timing thereof; the regulatory process and outcome of regulatory actions by the FDA related to the IND for XP23829 and the timing thereof; the potential for starting clinical development of XP23829 and the timing thereof; XenoPort's future XP23829 development plans; the potential suitability of XP23829 as a treatment for RRMS and/or psoriasis; and the therapeutic and commercial potential of XenoPort's clinical product candidates. 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 "goal," "hopeful," "intended," "might," "potential," "will" 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, risks related to XenoPort's ability to successfully conduct clinical trials in the anticipated timeframes, or at all; the uncertainty of the FDA IND clearance process and other regulatory requirements; XenoPort's dependence on its current and additional collaborative partners; and the uncertain therapeutic and commercial value of XenoPort's product candidates. These and other risk factors are discussed under the heading "Risk Factors " in XenoPort's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, filed with the Securities and Exchange Commission on May 8, 2012. 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 trademark of XenoPort, Inc.
Horizant is a registered trademark of GSK.
Regnite is a registered trademark of Astellas.
Source: XenoPort, Inc.
Jackie Cossmon, 408-616-7220