XenoPort designed and developed several product candidates based on its unique prodrug technology. Prodrugs are designed to enable better absorption of a drug into the body. A prodrug is created by adding a chemical structure to a known active agent or drug to form a new molecule which is specially designed to be absorbed by the body.
XenoPort has several product candidates that are ready to enter mid-to-late stage clinical development. We are focusing our efforts today on the commercialization of HORIZANT and intend to seek partners for our development stage assets that are not currently partnered.
The National Institute on Alcohol Abuse and Alcoholism, or the NIAAA, has initiated a clinical study of HORIZANT (gabapentin enacarbil) as a potential treatment for alcohol use disorder, or AUD. HORIZANT is not currently approved for the treatment of AUD. For full HORIZANT prescribing information, please click here. In a previous study of gabapentin (the parent drug of gabapentin enacarbil), patients with AUD that were treated with gabapentin demonstrated a reduction in heavy drinking days. XenoPort and the NIAAA will both have access to any potential clinical trial data that is generated from the NIAAA study.
Our monomethyl fumarate (MMF) prodrug product candidate, known as XP23829, was uniquely created by XenoPort scientists with a goal of improving the side effect profile and the absorption capabilities of MMF. MMF has been shown to be an active agent that treats patients with relapsing forms of multiple sclerosis (MS) and those suffering from psoriasis.
In XenoPort’s preclinical psoriasis and multiple sclerosis animal studies comparing molar equivalent doses of dimethyl fumarate (DMF) and XP23829, XP23829 demonstrated greater improvements in efficacy endpoints as compared to DMF. Toxicology studies conducted in two species showed that XP23829 caused less stomach irritation when compared to DMF. Preclinical data suggests that XP23829 may have the potential for consistent and predictable absorption and less flushing compared to DMF.
In September 2015, we completed a successful Phase 2 clinical trial of XP23829 in patients with moderate-to-severe chronic plaque-type psoriasis, and believe that the data generated from this study support the potential evaluation of XP23829 as a treatment for either moderate-to-severe chronic plaque-type psoriasis or relapsing-forms of MS.
Because we are currently focusing our efforts on the commercialization of HORIZANT, we have discontinued development of XP23829 and are seeking a third-party partner for the potential continued development and commercialization of XP23829. XenoPort currently holds exclusive worldwide rights to XP23829.
Arbaclofen placarbil (AP), is a prodrug of the R-isomer of baclofen that we discovered and developed with a goal to improve upon the inherent therapeutic deficiencies of baclofen, a generic drug that is a selective GABA-B agonist.
In May 2014, XenoPort entered into a license agreement with Indivior PLC granting it exclusive, world-wide rights for the development and commercialization of AP for all indications. Indivior is currently developing AP as a potential treatment for AUD.
XP21279 is a prodrug of L-dopa that we discovered and developed with a goal to improve upon the inherent therapeutic deficiencies of current L-dopa products for the treatment for patients with Parkinson’s Disease.
Because we are currently focusing our efforts on the commercialization of HORIZANT, we have discontinued development of XP21279 and are seeking a third-party partner for the potential continued development and commercialization of XP21279. XenoPort currently holds exclusive worldwide rights to this product candidate.
Forward-Looking Statement of XenoPort, Inc., Santa Clara, CA, USA
This presentation contains “forward-looking” statements, including, without limitation, all statements related to the suitability of gabapentin enacarbil as a potential treatment for AUD; the suitability of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of MS; the suitability of AP as a potential treatment for AUD; the suitability of XP21279 as a potential treatment for Parkinson’s Disease; XenoPort’s efforts to seek third-party partners for the potential continued development of XP23829 and XP21279; XenoPort’s belief that data generated from its Phase 2 clinical trial of XP23829 support further evaluation of XP23829; and the potential continued development of XP23829 and XP21279 by potential future third-party business partners. Any statements contained in this presentation that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “can,” “further,” “goal,” “potential,” “seek,” “suggest,” “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 includewithout limitation, the difficulty and uncertainty of pharmaceutical product development and the uncertain results and timing of clinical trials and other studies, including the risk that success in preclinical testing and early clinical trials do not ensure that later clinical trials will be successful; risks related to XenoPort’s dependence on current and potential future third-party business partners to advance any development of XenoPort’s product candidates, including the risk that XenoPort may be unable to enter into future collaborative, partnering or other strategic relationships to advance the development of either XP23829 or XP21279 in a meaningful way, or at all, in which case, XenoPort may not receive any return on its investments in XP23829 or XP21279, as well as the risk that XenoPort is wholly dependent on Indivior to develop and commercialize AP and is currently dependent on the NIAAA to conduct and complete its clinical study of gabapentin enacarbil as a potential treatment for AUD; the risk that XenoPort’s product candidates will require significant additional clinical testing prior to any possible regulatory approvals and failure could occur at any stage of their development; the uncertainty of the FDA’s review process and other regulatory requirements that must be satisfied in order to further the development of XenoPort’s product candidates, if at all; the uncertainty of protecting and expanding XenoPort’s intellectual property rights, including the risk that patent rights may not provide XenoPort or its third-party business partners with sufficient protection against competitive products or otherwise cover commercially valuable products or processes; 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 most recent Annual Report on Form 10-K and in its most Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), as well as any amendments thereto reflected in subsequent filings with the SEC. 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 XenoPort’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
AUD (Alcohol Use Disorder)
Drinking more or longer than intended along with recurrent thoughts about cutting down on alcohol consumption or stopping could mean that you suffer from Alcohol Use Disorder, or AUD. According to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM–5, that was issued by the American Psychiatric Association in May 2013, a person with AUD is anyone meeting any two of 11 criteria in the DSM–5 during the same 12-month period with the severity of AUD defined as mild, moderate or severe based on the number of criteria met.
According to the NIAAA, approximately 7.2 % or 17 million adults in the United States ages 18 and older had an AUD in 2012. This includes 11.2 million men and 5.7 million women.