Phase 3 Clinical Trial Data of Lubiprostone in Japanese Patients with Chronic Idiopathic Constipation Presented at DDW 201

BETHESDA, Md. & ABBOTT PARK, Ill.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (“Sucampo”) (NASDAQ: SCMP) and Abbott (NYSE: ABT) today reported data from a phase 3 clinical efficacy trial in 124 Japanese chronic idiopathic constipation (CIC) patients as well as from a phase 3 long-term safety trial in an additional 209 Japanese CIC patients. The purpose of the studies was to confirm the treatment effect and safety profile of lubiprostone capsules in Japanese CIC patients.

The primary endpoint of the efficacy trial, a change from baseline in the number of spontaneous bowel movements (SBMs) at the end of the first week of treatment, was met by the patients taking 24-mcg lubiprostone twice a day (p<0.001 vs. placebo treatment). Lubiprostone was shown to be well-tolerated and there were no reported severe adverse effects in either trial.

The secondary endpoints of the efficacy trial included the change from baseline in the weekly average number of SBMs at Weeks 2, 3 and 4, and scores in the short form 36 (SF-36) questionnaire and the irritable bowel syndrome quality of life (IBS-QOL) questionnaire. The aim of the long-term safety trial was a comparison of quality of life scores at baseline and after treatment.

Data describing the results of the two trials were the subject of poster #DDW/AGA 1038006, titled Lubiprostone Improves Not Only Spontaneous Bowel Movement But Also Quality of Life in Patients with Chronic Idiopathic Constipation: Phase III Randomized, Double-Blind, and Placebo-Controlled Study and Long-Term Treatment Study In Japan, were reported at the annual Digestive Disease Week (DDW) conference, held in Chicago, Illinois, and included these highlights:

  • In the four-week efficacy clinical trial:

    • Patients treated with lubiprostone had a statistically significant (p<0.001) change from baseline at Week 1 in the average number of reported SBMs (change from baseline of 3.7 in the lubiprostone arm vs. 1.3 in the placebo arm).
    • Lubiprostone treated patients had statistically significant changes from baseline in the weekly SBM frequency at Weeks 2, 3 and 4 (p<0.001 at Week 2; p<0.01 at Week 3; and, p<0.05 at Week 4) when compared to placebo.
    • Improvement in stool consistency also was statistically significant (p<0.001) in the lubiprostone group at all study weeks.
    • In a comparison of time to first SBM following initiation of therapy, the lubiprostone group had a statistically significant (p<0.01) increase in the proportion of patients reporting first SBMs within 24 hours as compared to placebo.
    • Patients’ “global assessment of treatment effectiveness” was significantly improved for lubiprostone-treated patients vs. those treated with placebo over the duration of the study.
  • In the 48 week open-label, long-term safety trial:

    • Throughout the 48-week treatment period, patients reported a statistically significant increased average number of weekly SBMs (p<0.001) than were observed at baseline.
    • As compared to baseline evaluation of quality of life measures, lubiprostone treatment resulted in better SF-36 and IBS-QOL scores overall. Specifically, lubiprostone-treated patients reported statistically significant improvements in the following domains of the SF-36 questionnaire at Week 48: physical function (p<0.01), bodily pain (p<0.001), general health (p<0.001), and emotional role (p<0.05); lubiprostone scored significantly (p<0.001) in each domain within the IBS-QOL questionnaire.

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, said, “We are excited that these data confirm results of previous clinical trials of lubiprostone in Japanese patients and that they are similar to prior clinical results in a more ethnically diverse patient population. Lubiprostone appears to be a promising agent for Japanese CIC patients.”

Gary Winer, Vice President, Abbott Japan, which holds commercialization rights to lubiprostone in Japan, said, “The combined results of the phase III efficacy trial and the long-term safety study of AMITIZA highlight an important new treatment for people in Japan suffering from chronic idiopathic constipation. We are excited to bring such a promising new product to the Japanese market.”

About the phase 3 clinical trial designs of lubiprostone for chronic idiopathic constipation

The phase 3 double-blinded, placebo-controlled, efficacy clinical trial of lubiprostone enrolled 124 Japanese CIC patients at multiple sites. Each patient received one lubiprostone 24-mcg, or placebo, capsule twice daily for 28 days.

The long-term phase 3 safety clinical trial was an open-label, multi-center study in which Japanese CIC patients received one 24-mcg lubiprostone capsule twice a day for up to 48 weeks. A total of 209 patients were enrolled, 173 patients completed at least 24 weeks of treatment, and 163 patients completed the full 48 weeks of treatment.

Each enrolled patient had a history of fewer than three SBMs per week for at least six months, which was confirmed during a 14-day screening period.

About lubiprostone

Lubiprostone (trade named AMITIZA®) is a local activator of ClC-2 chloride channels in cells lining the small intestine. Lubiprostone increases fluid secretion into the intestinal tract. This increased fluid level softens the stool, facilitating intestinal motility and bowel movements. It is reported that the type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.

AMITIZA is a registered trademark of Sucampo Pharmaceuticals, Inc.

About chronic idiopathic constipation

Constipation is characterized by infrequent and difficult passage of stool and becomes chronic when a patient suffers specified symptoms for at least six months. Chronic constipation is idiopathic if it is not caused by other diseases or by use of medications. Symptoms of chronic idiopathic constipation include straining, hard stools, bloating and abdominal pain or discomfort.

About AMITIZA for Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C)

AMITIZA is indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women >18 years of age and older.

In clinical trials of AMITIZA (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with CIC, AMITIZA reached the primary endpoint of the change from baseline in the mean number of SBMs, with statistical significance. These data demonstrated that AMITIZA increased the range of the number of spontaneous bowel movements (SBMs) in the treatment arms from 1.37 to 3.71-4.34 in Study SC0131 and 1.28 to 3.69-4.64 in Study SC0232, respectively. In the placebo arms of those studies, the range of SBMs went from 1.47 to 1.39-2.02 and from 1.52 to 1.85-2.47 in Study SC0131 and SC0232, respectively.

In clinical trials of AMITIZA (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with IBS-C, AMITIZA again met the primary endpoint, the percentage of overall responders in drug vs. placebo, with statistical significance. These data demonstrated that AMITIZA-treated patients in Study 431 responded to treatment at a higher rate (13.8% vs. 7.8%) or a 76% response rate over placebo rate. In Study 432, AMITIZA-treated patients responded to treatment at a similarly high rate (12.1% vs. 5.7%) or 112% response rate over placebo rate. In trials designed to minimize the placebo effect, verum response rates were 76% and 112% over reported placebo rates in two separate, well-controlled, intent-to-treat pivotal trials. The trial designs were required by the FDA to minimize the placebo effect which is common in gastrointestinal studies and these particular treatment populations.

Important Safety Information

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment

The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with CIC, the most common adverse reactions (incidence >4%) were nausea (29% vs. 3%), diarrhea (12% vs. 1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distention (6% vs. 2%), and flatulence (6% vs. 2%).

In clinical trials of AMITIZA (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with IBS-C, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.

Please see complete Prescribing Information in the U.S. at www.amitiza.com.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., founded in the U.S. in 1996, is an international pharmaceutical company based in Bethesda, Maryland, focused on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ Chairman and Chief Executive Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief Executive Officer and currently Executive Advisor, International Business Development and a member of the Board of Directors. For more information about Sucampo Pharmaceuticals, please visit www.sucampo.com.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott’s news releases and other information are available on the company’s Web site at www.abbott.com.

Sucampo Forward-Looking Statement

Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” ”may” or other similar expressions. Forward-looking statements include statements about the potential utility of AMITIZA to treat particular indications and expected data availability dates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those described in Sucampo Pharmaceuticals’ filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2010, and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.



CONTACT:

Sucampo Pharmaceuticals, Inc.
Kate de Santis, 1-240-223-3834
[email protected]
or
Abbott
Alysa Spittle, 1-847-938-8446
[email protected]

KEYWORDS:   United States  Asia Pacific  North America  Illinois  Maryland  Japan

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Pharmaceutical

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