Navigation Links
Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowel Syndrome

Statistically Significant Reduction of IBS Pain and Normalizing Motility

Effect Observed

SAN DIEGO, May 20 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. today announced the results of a recent Phase 2b study of its oral kappa opioid receptor agonist, asimadoline, which demonstrated statistically significant results in the treatment of Irritable Bowel Syndrome (IBS). Asimadoline produced significant improvement in diarrhea-predominant (D-IBS) and alternating (A-IBS) patients across multiple parameters including the primary endpoint of pain, as well as secondary endpoints of urgency, frequency and bloating in both males and females. In D-IBS patients, therapeutic benefit was observed within the first month of treatment and was sustained for the three month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial involving 596 subjects. These data were featured today in a late-breaking oral presentation session at the Digestive Disease Week 2008 Annual Meeting.

Study Results

Of the 596 patients randomized in the trial, approximately 33 percent were characterized as D-IBS, 37 percent constipation predominant (C-IBS) and 31 percent alternating between diarrhea and constipation (A-IBS).

-- In the overall patient group, patients with at least moderate pain

achieved a 17 percent improvement in percent number of months with

adequate relief of IBS pain compared to placebo (40 percent vs. 23

percent) with both the 0.5 mg (p=0.006) and the 1.0 mg (p=0.005) dose

of asimadoline.

- Evaluation by IBS subtype revealed benefit in D-IBS and A-IBS


- Benefit in C-IBS patients was not observed.

- The rate of adverse events was similar in asimadoline and placebo

treated subjects.

-- Patients with D-IBS with at least moderate pain achieved a 27 percent

improvement in the percent number of months with adequate relief of

IBS pain compared to placebo (47 percent vs. 20 percent, p=0.011) with

the 0.5mg dose of asimadoline.

- A 25 percent increase in pain free days was seen with 0.5 mg

asimadoline as compared with placebo (p=0.001) during the 12-week

dosing period. This represents an increase of approximately 20

pain free days over that seen with placebo.

- Statistically significant (p<0.05) improvement in pain was seen by

week three and persisted for the duration of treatment.

- Statistically significant improvements were also seen in D-IBS

patients receiving the 0.5 mg dose of asimadoline in all of the

following secondary endpoints: urgency, adequate relief of IBS

symptoms, stool frequency, bloating and daily pain. Statistically

significant improvement was also seen in urgency, adequate relief

of IBS symptoms, bloating and daily pain in patients receiving

the 1.0 mg dose.

- Benefit was seen in female and male patients.

-- Patients with A-IBS with at least moderate pain achieved a 23 percent

improvement in the percent number of months with adequate relief of

IBS pain compared to placebo (50 percent vs. 27 percent, p=0.022) with

a 1.0 mg dose of asimadoline.

- Statistically significant benefit was also seen in the secondary

endpoint of adequate relief of IBS symptoms in patients receiving

the 1.0 mg dose of asimadoline compared to placebo (57 percent vs.

33 percent, p=0.032).

- Benefit was seen in female and male patients.

Study Design

D-IBS, C-IBS, and A-IBS patients were recruited. Patients underwent a two-week screening, a 12-week treatment and a four-week follow-up period, and they received identical appearing placebo, 0.15 mg, 0.5 mg or 1.0 mg tablets of asimadoline twice daily for the treatment period. Throughout the trial, patients entered data daily by IVRS (interactive voice response system). The primary endpoint was number of months a patient was a responder for adequate relief of pain, where the primary measure was the question, "In the past 7 days have you had adequate relief of your IBS pain or discomfort?" asked once every 7 days. A monthly responder replied "yes" at least three weeks per month. The secondary endpoints were abdominal pain, stool frequency and consistency, urgency, bloating, adequate relief of IBS symptoms and straining. Secondary endpoints were also collected using IVRS. Adverse events, labs and echocardiograms were also collected.

About Irritable Bowel Syndrome

Irritable bowel syndrome is a common, chronic gastrointestinal disorder characterized by abdominal pain and discomfort associated with alterations in bowel habits. The bowel abnormalities may manifest as diarrhea-predominant disease, constipation-predominant disease, or alternation between diarrhea and constipation. IBS is estimated to afflict approximately 12 percent of the adult population in the United States and Europe, with roughly equal prevalence of each subtype. For reasons that remain unknown, IBS is a female-predominant disorder, with two-thirds to three-quarters of the subjects being female.

Lotronex (alosetron), a selective 5-HT3 receptor antagonist, is the only drug currently approved by the FDA for the treatment of D-IBS; however, due to safety concerns, Lotronex was removed from the market in 2001 and re-launched in 2002 under a strict risk management program. No treatment is currently approved by the FDA for A-IBS. There is, therefore, an urgent unmet clinical need for a safe and effective treatment for the 20 million Americans who suffer from D-IBS and A-IBS.

About Asimadoline

Asimadoline is an orally administered small molecule that is a highly selective kappa opioid receptor agonist. Kappa opioid receptors are found in the digestive tract and are believed to play an important role in control of visceral pain and bowel motility. Asimadoline was originally discovered by Merck KGaA of Darmstadt, Germany. In 2005, Tioga purchased asimadoline from Merck and acquired by assignment all worldwide rights. Asimadoline has been tested in over 1100 subjects and has demonstrated a promising safety profile.

About Tioga

Tioga Pharmaceuticals, Inc. is a pharmaceutical company headquartered in San Diego, CA focused on developing novel treatments for gastrointestinal diseases. Tioga is currently planning Phase 3 development of asimadoline for the treatment of D-IBS and A-IBS and a Phase 2b trial of asimadoline for the treatment of functional dyspepsia. Both disorders represent a large unmet medical need and a substantial market opportunity. For more information, please visit

Contact: David Urso, Chief Business Officer and General Counsel

Phone: 858-964-5021


Media: Cory Tromblee, Porter Novelli Life Sciences

Phone: 617-897-8294


SOURCE Tioga Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. ( Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
(Date:10/12/2015)... October 12, 2015 ... Pipeline Review, H2 2015 market research report provides ... pipelines by identifying new targets and MOAs to ... . --> . ... spread across 62 pages, analyzing 6 companies, 8 ...
(Date:10/12/2015)... , Oct. 12, 2015 Device usage ... need to help integrate these devices into existing clinical ... ergonomic healthcare mounting and mobility solutions, has launched the ... cart yet, for a wide array of laptops and ... SV10 was developed exclusively for Microsoft Surface and is ...
(Date:10/12/2015)... 2015  Today, Divurgent is honored to announce Paul ... former CIO, Paul brings 15 years of hands-on experience as ... with today,s CIOs, he is one. The challenges that face ... faced, and his new role with Divurgent allows him to ... an organization. ...
Breaking Medicine Technology:
(Date:10/12/2015)... ... October 12, 2015 , ... American Family Care (AFC), the nation’s ... by opening its 151st medical center. Located at 606A Boll Weevil Circle in Enterprise, ... continue fulfilling our mission of making quality health care accessible and economical with the ...
(Date:10/12/2015)... ... October 12, 2015 , ... At first glance, it looks ... one would find atop a drink in a tiki bar. But the Parachute® Ventricular ... at Allegheny General Hospital (AGH) could potentially signal a new way of treating people ...
(Date:10/12/2015)... IL, USA (PRWEB) , ... October 12, 2015 ... ... high-fidelity personal audio products, will present the latest version of Companion Mics, the ... for audiometry, at the European Union of Hearing Aid Acousticians’ (EUHA) 60th Annual ...
(Date:10/12/2015)... ... October 12, 2015 , ... FEI ... workforce resilience from EAP to crisis management, will present a session at the ... Wisconsin, Oct. 14-16, 2015. , FEI’s Chief Operating Officer Daniel Potterton will present ...
(Date:10/12/2015)... ... October 12, 2015 , ... To help raise awareness this ... to the National Breast Cancer Foundation. The National Breast Cancer Foundation is dedicated ... early detection, education, and support services. , The annual campaign to increase breast ...
Breaking Medicine News(10 mins):