UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 15, 2015
XENOPORT, INC.
(Exact
name of registrant as specified in its charter)
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| Delaware |
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000-51329 |
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94-3330837 |
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(Commission |
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(IRS Employer |
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File Number) |
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Identification No.) |
3410 Central Expressway
Santa Clara, California 95051
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (408) 616-7200
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Section 7—Regulation FD
| Item 7.01 |
Regulation FD Disclosure. |
As reported under Item 8.01 of this current report on
Form 8-K, XenoPort, Inc. (the “Company”) issued a press release announcing positive preliminary top-line results from its Phase 2 clinical trial of XP23829, its development-stage product candidate, as a potential treatment for
moderate-to-severe chronic plaque-type psoriasis. During a conference call and webcast scheduled to be held at 8:30 a.m. Eastern Time on September 15, 2015, Company management will discuss the preliminary top-line XP23829 Phase 2 clinical trial
results. The slide presentation for the conference call and webcast is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The furnishing of the attached presentation is not an admission as to the materiality of any information therein. The information contained in
the slides is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements
that the Company has made, including the press release filed as Exhibit 99.2 hereto, and may make from time to time by press release or otherwise.
The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed
“filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act
of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Section 8—Other
Events
On September 15, 2015, the Company issued a press release announcing
positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis. A copy of the press release is filed as Exhibit 99.2 hereto and is incorporated by
reference herein.
Section 9—Financial Statements and Exhibits
| Item 9.01 |
Financial Statements and Exhibits. |
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| Exhibit
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Description |
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| 99.1 |
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Company slide presentation dated September 15, 2015* |
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| 99.2 |
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Press release, dated September 15, 2015, titled “XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis” |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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XENOPORT, INC. |
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(Registrant) |
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| Dated: September 15, 2015 |
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By: |
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/s/ William G. Harris |
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William G. Harris |
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Senior Vice President of Finance and |
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Chief Financial Officer |
EXHIBIT INDEX
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| Exhibit
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Description |
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| 99.1 |
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Company slide presentation dated September 15, 2015* |
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| 99.2 |
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Press release, dated September 15, 2015, titled “XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential Treatment for Patients with Psoriasis” |
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| Exhibit 99.1
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XP23829 PHASE 2 PSORIASIS TRIAL
PRELIMINARY
TOPLINE DATA PRESENTATION
SEPTEMBER 15, 2015
© COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED.
SAFE HARBOR DISCLAIMER
These slides and the
accompanying oral presentation by XenoPort, Inc. contain forward-looking statements that involve risks and uncertainties, including all statements relating to future clinical and commercial opportunities for XP23829; the suitability of XP23829 as a
potential treatment for moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of multiple sclerosis (MS); XenoPort’s belief that the efficacy of XP23829 is likely to improve with a more extended duration of treatment beyond 12
weeks; XenoPort’s beliefs regarding the potential advantages of
XP23829 and that XP23829 could lead to a
differentiated product in psoriasis; the XP23829 development program, including potential future Phase 3 clinical studies and the timing thereof, and potential partnerships that could accelerate the development of XP23829; potential regulatory
matters, including XenoPort’s expectation that a single positive Phase 3 clinical trial of XP23829 could support a New Drug Application submission to the U.S. Food and Drug Administration; and the commercial and other value proposition and
opportunities for XP23829 and its potential regulatory approval. XenoPort can give no assurance with respect to these statements, and XenoPort assumes no obligation to update them. Further, these forward-looking statements are based upon
XenoPort’s current expectations and involve risks and uncertainties. The following important factors, among others, could cause actual results and the timing of events to differ materially from those anticipated in such forward-looking
statements: the difficulty and uncertainty of pharmaceutical product development and the uncertain results and timing of clinical trials, including the risk that success in preclinical testing and early clinical trials do not ensure that later
clinical trials, such as Phase 3 clinical trials, will be successful, and that the results of clinical trials by other parties may not be indicative of the results in trials that XenoPort may conduct; risks related to XenoPort’s ability to
successfully advance XP23829 development and to conduct clinical trials in the anticipated timeframes, or at all; the risk that XenoPort’s belief regarding potential distinguishing attributes of XP23829 may not be observed or validated in
future Phase 3 or other clinical testing; that XP23829 will require significant additional clinical testing prior to any possible regulatory approvals and failure could occur at any stage of its development; the uncertainty of the FDA’s review
process and other regulatory requirements; XenoPort’s ability to obtain and its dependence on potential future collaborative partners; the availability of resources to develop XP23829 and to support XenoPort’s operations; and the uncertain
therapeutic and commercial value of XP23829. 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 June 30, 2015 filed with the Securities
and Exchange Commission on August 6, 2015.
PAGE 2 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
KEY OBSERVATIONS FROM PRELIMINARY RESULTS OF XP23829 PHASE 2 CLINICAL TRIAL
Met primary endpoint of % change in PASI with 800 QD and 400 BID doses (p£0.001)
Efficacy still improving at end of treatment (week 12) Low incidence of flushing (similar to placebo) Low incidence and
severity of lymphocyte reduction with recovery to within normal limits by four to six weeks post treatment First demonstration that a MMF prodrug other than DMF can be effective on a clinical symptom endpoint
PAGE 3 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
XP23829 PHASE 2 PSORIASIS TRIAL DESIGN
Titration
400 mg BID Titration 800 mg QD Titration 400 mg QD Titration Placebo
Screening/ Post-Treatment Week -4 0
Titration 3 Steady State Dosing 12 16 Washout Follow-up
Study Design Randomized, double-blind, multicenter,
parallel group, placebo-controlled, dose-finding efficacy
and safety study in subjects with moderate-to-severe
chronic plaque-type psoriasis
Number of Sites 33 sites in United States
Number of Subjects 200 randomized 1:1:1:1 Stratified by prior biologic use
Primary Endpoint The percent change in Psoriasis Area and Severity Index (PASI) score from Baseline at week 12
PAGE 4 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
KEY ELIGIBILITY CRITERIA
Chronic plaque-type
psoriasis diagnosed for at least six months Moderate-to-severe psoriasis as defined by:
PASI (Psoriasis Area
and Severity Index) score of ³12
sPGA (Static Physician’s
Global Assessment) score of ³3
BSA (body surface area) affected
by plaque-type psoriasis of ³10%
Candidate for phototherapy
and/or systemic therapy
May be either treatment naïve or have a history of previous treatment
Excluded subjects with inadequate response to more than three approved systemic agents for psoriasis
PAGE 5 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
KEY DEMOGRAPHICS / BASELINE VALUES
XP 400mg XP
800mg XP 400 mg Placebo
QD (N=48) QD (N=53) BID (N=46) (N=47)
Mean PASI Score 18.3 18.4 17.7 19.3
Mean BSA (%) 22.9% 24.3 % 23.3 % 26.4 %
% Patients with
Moderate sPGA 66.7% 69.8% 69.6%
70.2%
% Patients with
Prior Systemic 33.3% 39.6% 37.0% 27.7%
Biologic
Median Body
Weight (kg) 90.95 95.30 92.05 95.30
PAGE 6 |
XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
PRIMARY ENDPOINT: PERCENT CHANGE FROM
BASELINE IN
PASI SCORE AT WEEK 12
XP 400mg XP 800mg QD XP 400 mg Placebo
QD (N=48) (N=53) BID (N=46) (N=47)
Least Squares
Mean -38.1 -48.2 -50.7 -25.0
p-value 0.066 0.001 <0.001
Modified Intent to Treat (mITT) population and Mixed Model for Repeated Measures (MMRM) statistical analysis
PAGE 7 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
LEAST SQUARES MEAN PERCENT CHANGE FROM BASELINE IN PASI SCORE OVER TIME
mITT population, MMRM
PAGE 8 | XP093 TOPLINE
PRESENTATION | 15 SEPTEMBER 2015
EFFECT OF PRIOR BIOLOGIC USE ON PERCENT CHANGE FROM BASELINE IN PASI SCORE AT WEEK 12
No Prior XP 400mg XP 800mg XP 400 mg Placebo
Biologic QD (N=32) QD (N=32) BID (N=29) (N=34)
Least Squares -48.1 -56.1 -59.1 -26.5
Mean
P-value 0.011 <0.001 <0.001
Prior Biologic XP 400mg XP 800mg XP 400 mg Placebo
QD (N=16) QD (N=21) BID (N=17) (N=13)
Least Squares -17.4 -31.9 -38.1 -22.7
Mean
P-value 0.691 0.492 0.245
mITT population, MMRM
PAGE 9 | XP093 TOPLINE
PRESENTATION | 15 SEPTEMBER 2015
PASI RESPONDERS ANALYSIS AT WEEK 12
LOCF*
Imputation
60
50
40 38.0 39.1
Subjects 36.2
30
of
21.7
Percent 20
13.6 12.8 14.0
10 9.1
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
mITT population
| * |
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Last Observation Carried Forward |
PAGE 10 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
PASI RESPONDERS ANALYSIS AT WEEK 12 NO PRIOR BIOLOGIC SUBPOPULATION
LOCF Imputation
60
50.0
50 48.4
44.8
40
Subjects 30
of 23.3
20.7
Percent 20 19.4
12.1
10 9.1
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
mITT population
PAGE 11 | XP093 TOPLINE
PRESENTATION | 15 SEPTEMBER 2015
SAFETY OVERVIEW
No deaths or life-threatening
adverse events (AEs) No subjects met safety discontinuation criteria Majority of treatment emergent adverse events (TEAEs) were non-serious and mild or moderate in severity Three subjects with serious TEAEs – All recovered
One subject with acute cholecystitis; possibly related to XP23829 treatment, per investigator (800 mg QD)
One subject with enterocolitis; possibly related to XP23829 treatment, per investigator (400 mg BID)
One subject with an abdominal hernia; not related to XP23829 treatment, per investigator (400 mg QD)
PAGE 12 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
MOST COMMON (>10%) TREATMENT EMERGENT AES
XP
400mg XP 800mg XP 400 mg Placebo
QD (N=49) QD (N=55) BID (N=48) (N=48)
Diarrhea 11 (22.4%) 22 (40.0%) 19 (39.6%) 7 (14.6%)
Nausea 6 (12.2%) 4 (7.3%) 10 (20.8%) 6 (12.5%)
Abdominal
Pain 1 (2.0%) 7 (12.7%) 11 (22.9%) 2 (4.2%)
Vomiting 3 (6.1%) 7 (12.7%) 1 (2.1%) 1 (2.1%)
Headache 2 (4.1%) 3 (5.5%) 5 (10.4%) 2 (4.2%)
Flushing* 4 (8.2%) 3 (5.5%) 2 (4.2%) 3 (6.3%)
| * |
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Not >10% but a common AE of special interest for fumaric acid esters |
PAGE 13 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
TREATMENT EMERGENT AES
LEADING TO PERMANENT DRUG
WITHDRAWAL
XP 400mg XP 800mg XP 400 mg Placebo
QD (N=49) QD (N=55) BID (N=48) (N=48)
Diarrhea 2 (4.1%) 3 (5.5%) 7 (14.6%) 1 (2.1%)
Nausea 0 0 2 (4.2%) 2 (4.2%)
Abdominal Pain
1 (2.0%) 2 (3.6%) 3 (6.3%) 0
Vomiting 1 (2.0%) 1 (1.8%) 0 0
Headache 1 (2.0%) 0 2 (4.2%) 1 (2.1%)
PAGE 14 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
MAXIMUM LYMPHOCYTE GRADES AT ANY VISIT
XP 400mg
XP 800mg XP 400 mg Placebo
QD (N=49) QD (N=55) BID (N=48) (N=48)
Grade 1 3 (6.1%) 5 (9.1%) 7 (14.6%) 2 (4.2%)
Grade 2 2 (4.1%) 2 (3.6%) 1 (2.1%) 0
Grade 3 or 4 0 0 0 0
No subjects below 700 cells/mm3 at any visit
All
subjects were Grade 1 or less by 2 weeks post end of treatment All subjects returned within normal limits by 6 weeks post end of treatment
Grade 1: <1000-800 cells/mm3
Grade 2:
<800-500 cells/mm3
Grade 3: <500-200 cells/mm3
Grade 4: <200 cells/mm3
PAGE 15 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
KEY OBSERVATIONS FROM PRELIMINARY RESULTS OF XP23829 PHASE 2 CLINICAL TRIAL
Met primary endpoint of % change in PASI with 800 QD and 400 BID doses (p£0.001)
Efficacy still improving at end of treatment (week 12) Low incidence of flushing (similar to placebo) Low incidence and
severity of lymphocyte reduction with recovery to within normal limits by four to six weeks post treatment First demonstration that a MMF prodrug other than DMF can be effective on a clinical symptom endpoint
PAGE 16 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
THANK YOU
© COPYRIGHT 2015 XENOPORT, INC.
ALL RIGHTS RESERVED.
Appendix
PAGE 18 | XP093 TOPLINE PRESENTATION |
15 SEPTEMBER 2015
HISTORICAL TECFIDERA PHASE 3 PSORIASIS STUDY
Conducted at 10 sites in Europe. Unlikely to have enrolled many patients with prior biologic treatment 16-week study;
titration not described but likely 1 week Dose of TECFIDERA was 240 mg TID
Median PASI score reduction at week
12 for TECFIDERA was 59% vs 13% placebo. ~45% for TECFIDERA at week 8. Did not describe any imputation PASI reduction increased from week 12 to 16 PASI responders at week 16 (did not describe imputation)
PASI 50 65% vs 14% placebo
PASI 75 39% vs 1% placebo
Adverse Events
Flushing 42% vs. 9% placebo
Diarrhea 31% vs. 9% placebo
Abdominal Pain 12%
vs. 3 % placebo
Headache 11% vs. 6% placebo
Nausea 10% vs. 0% placebo
No indication of drop-out rates
PAGE 19 | XP093
TOPLINE PRESENTATION | 15 SEPTEMBER 2015
XP23829 PASI RESPONDERS ANALYSIS AT WEEK 12
LOCF
Imputation
60
50
40 38.0 39.1
Subjects 36.2
30
of
21.7
Percent 20
13.6 12.8 14.0
10 9.1
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
Observed case – Completed 12 weeks
60
53.6
50.0
50 46.9
40
Subjects 32.1
of 30
21.9
Percent 20 17.6 18.8
11.8
10
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
mITT population
PAGE 20 | XP093 TOPLINE
PRESENTATION | 15 SEPTEMBER 2015
XP23829 PASI RESPONDERS ANALYSIS AT WEEK 12 NO PRIOR BIOLOGIC SUBPOPULATION
LOCF Imputation
60
50.0
50 48.4
44.8
40
Subjects 30
of 23.3
20.7
Percent 20 19.4
12.1
10 9.1
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
Observed Case – Completed 12 wks
63.6 62.5
60 59.1
50
40
Subjects 31.8 31.3
of 30 27.3
Percent 20 16.7
12.5
10
0
Placebo 400 mg QD 800 mg QD 400 mg BID
PASI-50 PASI-60 PASI-70 PASI-75
mITT population
PAGE 21 | XP093 TOPLINE PRESENTATION | 15 SEPTEMBER 2015
Exhibit 99.2
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| NEWS RELEASE |
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Company Contact: |
| For Immediate Distribution |
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Jackie Cossmon |
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408-616-7220 |
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ir@XenoPort.com |
XenoPort Announces Positive Phase 2 Study Results for XP23829 as a Potential
Treatment for Patients with Psoriasis
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Efficacy observed with both 800 mg once-daily and 400 mg twice-daily XP23829 dosing |
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XP23829 safe and generally well-tolerated with low incidence of flushing similar to placebo |
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Low incidence/severity of lymphopenia seen with XP23829 |
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First clinical demonstration of efficacy of a MMF prodrug other than DMF |
SANTA CLARA, CA
— September 15, 2015 — XenoPort, Inc. (Nasdaq: XNPT) announced today positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis.
XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percent change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score. XP23829 is a
patented prodrug of monomethyl fumarate (MMF) in a novel oral formulation that was designed to potentially offer physicians and patients an effective, better tolerated and easier to use therapeutic option to currently available fumarate products.
Richard Kim, M.D., chief medical officer of XenoPort, stated, “We believe these clinical data demonstrate for the first time that a MMF prodrug
other than dimethyl fumarate (DMF) can be effective in reducing lesions in psoriatic patients. The magnitude of XP23829’s effect on the primary efficacy endpoint met our expectations for this relatively short duration trial and we are
particularly encouraged by the results with 800 mg once-daily dosing. Based on what is known about fumarates, we believe that the efficacy of XP23829 is likely to improve with a more extended duration of treatment beyond 12 weeks. We are also
pleased with the safety and tolerability profile of XP23829 emerging from this study. We believe that this demonstration of efficacy, safety and tolerability of XP23829 could lead to a differentiated product in psoriasis. We also believe that there
is potential for the observations from this study to read through to other potential indications such as multiple sclerosis (MS).”
Description of
the Trial
This randomized, double-blind, placebo-controlled Phase 2 clinical trial of XP23829 was conducted in 33 sites in the United States in
subjects with moderate-to-severe chronic plaque-type psoriasis. Two hundred eligible subjects were randomized to placebo or one of three treatment arms of XP23829: 400 mg or 800 mg once daily (QD) or 400 mg
twice daily (BID). The 12-week treatment period included a three-week titration period followed by nine weeks of treatment at the targeted dose. There was a washout phase of up to four weeks
prior to randomization for subjects who were previously taking systemic agents for the treatment of psoriasis. Treatment assignment was stratified based on prior biologic use and approximately 35% of randomized subjects had previous experience with
biological treatments for their psoriasis.
The primary endpoint of the study was the percent change from baseline to week 12 in PASI score. Least squares
mean percent reductions in PASI score at 12 weeks were as follows:
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400 mg QD |
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800 mg QD |
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400 mg BID |
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Placebo |
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-38.1 |
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-48.2 |
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-50.7 |
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-25.0 |
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0.066 |
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0.001 |
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<0.001 |
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XP23829 was safe and generally well tolerated. There were no deaths or life-threatening adverse events. No subjects met the
safety discontinuation criteria and the majority of treatment emergent adverse events were non-serious and mild or moderate in severity. Diarrhea adverse event rates were consistent with other drugs in the fumaric acid ester class ranging from 22%
to 40% in the XP23829 treatment groups compared with 15% for placebo. Other treatment emergent adverse events occurring at an incident rate of greater than or equal to 10% were nausea, abdominal pain, vomiting and headache. The incidence of flushing
in the XP23829 dose groups was similar to placebo. Gastrointestinal events were the most frequent adverse event leading to withdrawal during XP23829 treatment. There were two treatment emergent serious adverse events assessed as possibly related to
treatment with XP23829: acute cholecystitis and enterocolitis. Both subjects recovered.
No subjects experienced Grade 3 or Grade 4 lymphopenia. Less than
5% of subjects in any XP23829 treatment group reached Grade 2 lymphopenia and less than 15% reached Grade 1 at any visit. Lymphocyte levels in all subjects experiencing lymphopenia returned to within normal limits after treatment.
“I’m excited to have participated in this phase 2 study with positive efficacy data that we believe justifies further development of XP23829 into
moderate-to-severe chronic plaque-type psoriasis,” stated Alice Bendix Gottlieb, M.D., Ph.D., Dermatologist-in-Chief; Harvey B. Ansell Professor of Dermatology, Tufts University School of Medicine and Lead Investigator for the XP23829 trial.
“Despite the wide availability of biologics, there still remains a significant unmet medical need for a more effective, safe, well-tolerated, and convenient oral treatment for patients with psoriasis. Fumarates have been the leading
treatment for psoriasis in Germany for more than 2 decades. With this long-term real-world fumarate experience and these data in consideration, I look forward to the potential of seeing XP23829 in Phase 3 development for moderate-to-severe
chronic plaque-type psoriasis.”
“We are extremely pleased by the preliminary top-line results from this Phase 2 study. I want to thank the
clinical investigators and the psoriasis sufferers who participated in the study. We look forward to getting the complete data set for this trial later this month and to presenting more comprehensive results at future medical conferences and in
publications,” stated Ronald W. Barrett, Ph.D., chief executive officer of XenoPort.
Dr. Barrett continued, “In the near future, we intend to share these data with psoriasis and multiple sclerosis experts, speak with regulatory authorities regarding next steps and
explore potential partnerships that could accelerate the development of XP23829 globally. We recently completed non-clinical development studies and manufacturing activities necessary to support Phase 3 development and we believe we will be ready to
potentially initiate Phase 3 studies in 2016.”
Conference Call
XenoPort will host a webcast presentation today at 8:30 a.m. Eastern Time to discuss the preliminary top-line XP23829 Phase 2 clinical trial results. The live
presentation may be accessed via the Calendar of Events page in the Investors section of the XenoPort website at www.XenoPort.com. A replay of the presentation will be available via the Internet for one month following the live presentation
and can be accessed after 1:30 p.m. Eastern Time today.
The presentation may be accessed via phone by dialing 1-888-275-3514. International callers may
access the live call by dialing 706-679-1417. The reference number to enter the call is 41274020. The replay of the call will be available for one week and may be accessed after 11:30 a.m. Eastern Time today via phone at 1-855-859-2056 for domestic
callers, or 404-537-3406 for international callers. The reference number to enter the replay of the call is 41274020.
About XP23829
XP23829, an investigational drug discovered and currently under development by XenoPort, is a fumaric acid ester compound that is a prodrug of MMF. Fumaric
acid ester compounds have shown immuno-modulatory and neuroprotective effects in cell-based systems and preclinical models of disease. TECFIDERA, which is approved for relapsing forms of MS in the United States and relapsing-remitting MS in the
European Union and FUMADERM, which is approved in Germany for psoriasis, are based on another MMF prodrug known as DMF.
XP23829 is protected by a U.S.
composition-of-matter patent that currently has an expiration date of 2029. In addition XenoPort holds 48 issued patents worldwide, including those providing coverage for XP23829 and other MMF prodrug compositions and their uses, crystalline forms
of XP23829, methods of treatment with MMF prodrugs and oral dosage forms.
About Psoriasis
Psoriasis is a chronic, systemic, inflammatory disease that manifests in the skin and/or joints. It typically manifests as thick scaling red plaques, with
variable morphology and distribution, resulting from an unusually high rate of skin cell growth. There is no cure for psoriasis, and treatment often requires complex medical intervention. The main cause of psoriasis is uncertain, but it is thought
to be caused by autoimmunity, genetic predisposition and environmental factors.
Psoriasis is the most prevalent autoimmune disease in the United States
with as many as 7.5 million Americans suffering from the condition. It is estimated that approximately 1.5 million adults in the United States are considered to have moderate-to-severe psoriasis and between 150,000 and 260,000 new cases of
psoriasis are diagnosed each year.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the
potential treatment of neurological disorders. XenoPort is currently commercializing HORIZANT® (gabapentin enacarbil) Extended-Release Tablets in the United States and developing its novel
fumaric acid ester product candidate, XP23829, as a potential treatment for patients with moderate-to-severe chronic plaque-type psoriasis and potentially for relapsing forms of multiple sclerosis.
REGNITE® (gabapentin enacarbil) Extended-Release Tablets is being marketed in Japan by Astellas Pharma Inc. XenoPort has entered into a clinical trial agreement with the National Institute on
Alcohol Abuse and Alcoholism (NIAAA) under which the NIAAA has initiated a clinical trial evaluating gabapentin enacarbil as a potential treatment for alcohol use disorder, and XenoPort has granted exclusive world-wide rights for the development and
commercialization of its clinical-stage oral product candidate, arbaclofen placarbil, to Indivior PLC for all indications. XenoPort’s pipeline of product candidates also includes a potential treatment for patients with idiopathic
Parkinson’s disease.
To learn more about XenoPort, please visit the website at www.XenoPort.com.
Forward-Looking Statements
This press release contains
“forward-looking” statements, including, without limitation, all statements related to furthering the development of XP23829, including XenoPort’s belief that it will be ready to initiate potential Phase 3 studies of XP23829 in 2016;
the suitability of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis and/or relapsing forms of MS; XenoPort’s belief that the efficacy of XP23829 is likely to improve with a more extended duration of
treatment beyond 12 weeks; XenoPort’s intent to speak with regulatory authorities regarding next steps for XP23829 and to explore potential partnerships that could accelerate the development of XP23829 globally; and the therapeutic and
commercial potential of XP23829, including XenoPort’s beliefs that XP23829 could lead to a differentiated product in psoriasis and that there is potential for the observations from the Phase 2 clinical trial to read through to other potential
indications such as MS. 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 “believe,” “can,” “could,”
“intend,” “forward,” “further,” “likely,” “possibly,” “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, 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, such as Phase 3 clinical trials, will be successful, and that the results of clinical trials by other parties may not
be indicative of the results in trials that XenoPort may conduct; the risk that the final data from the Phase 2 clinical trial of XP23829 may be materially different from the preliminary data that XenoPort has reported, particularly as additional
and updated patient data becomes available; XenoPort’s ability to successfully advance XP23829 development and to conduct clinical trials in the anticipated timeframes, or at all; the risk that the completion of clinical trials for XP23829 may
be delayed or terminated as a result of many factors,
including delays in patient enrollment; the risk that XenoPort’s belief regarding potential distinguishing attributes of XP23829 may not be observed or validated in future Phase 3 or other
clinical testing; that XP23829 will require significant additional clinical testing prior to any possible regulatory approvals and failure could occur at any stage of its development; the uncertainty of the FDA’s review process and other
regulatory requirements that must be satisfied in order to further XP23829 development; the uncertainty of protecting and expanding XenoPort’s intellectual property rights, including the risk that patent rights may not provide XenoPort with
sufficient protection against competitive products or otherwise cover commercially valuable products or processes; XenoPort’s dependence on potential future collaborative partners; the availability of resources to develop XP23829 and to support
XenoPort’s operations; and the uncertain therapeutic and commercial value of XP23829. 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 June 30, 2015 filed with the Securities and Exchange Commission on August 6, 2015. 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.
HORIZANT, REGNITE and XENOPORT are registered trademarks of XenoPort, Inc.
Source code: XNPT2C
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