Irish Pharmaceutical AGI Therapeutics has announced that they are discontinuing development of their Irritable Bowel Syndrome candidate, Rezular, after showed disappointing results in Phase III trials.

Analysis from the trial, which involved 711 participants from 123 clinics in the U.S., South America and Europe, showed the drug did not significantly relieve the symptoms of diarrhea-predominant IBS (IBS-D), which include pain/discomfort or change in severity of pain.

The trial utilized four different regimens which included three different dosage levels of Rezular as well as placebo. This was a double-blind trial that was conducted over a period of 12 weeks. Results of the trial included:

  • The study did not show statistically significant differences between treatments in the primary endpoint of patient reported adequate relief of IBS symptoms
  • Statistically significant evidence favoring Rezular treatment was achieved in a number of secondary endpoints, particularly those relating to aspects of diarrhea (e.g. stool form as assessed by the Bristol Stool Scale), stool frequency and in the majority of sub-categories of quality-of-life (IBS-QOL) scores and in the overall IBS-QOL score
  • There were no statistically significant differences between treatments in adequate relief of pain/discomfort or change in severity of pain

AGI said it didn’t believe the drug would meet regulatory requirements as an effective therapy for the broad IBS-D population.

AGI’s CEO, John Devane Ph.D., said that while AGI is disappointed with results, it would not be a prudent use of resources to continue development of Rezular as a treatment for IBS-D. “A safe and effective therapy for patients with IBS-D remains elusive. We will now focus on prioritizing our pipeline and plan how best to move these forward.”

AGI is currently developing several other treatments for gastro-intestinal disorders:

  • A proof-of-concept Phase II trial with AGI-004, a controlled release transdermal mecamylamine patch, in the treatment of chemotherapy-induced diarrhoea (CID)
  • AGI-006, which contains the pure r-isomer form of the racemic CNS disorder drug, baclofen, and is in development for a number of GI and related conditions.
  • The ulcerative colitis candidate AGI-022 is being developed as an improved, once-daily form of aminosalicylic acid (ASA), formulated in a colon-targeted delayed-release/controlled-release delivery system
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