Phase I study will launch during first half of 2010 in diarrhea-predominant irritable bowel syndrome.
Ono Pharmaceutical obtained an exclusive license from Tioga Pharmaceuticals to develop and commercialize Tioga’s drug candidate for irritable bowel syndrome in Japan, South Korea, and Taiwan. Tioga will receive an up-front payment, development and commercial milestones, as well as royalties.
Ono’s initial development of asimadoline will focus on diarrhea-predominant irritable bowel syndrome (D-IBS). It plans to start Phase I studies in Japan during the first half of 2010.
“Asimadoline is expected to provide features that are not offered by existing therapies, as it has demonstrated efficacy particularly in abdominal pain and discomfort with good safety profiles in clinical testing to date,” remarks Gyo Sagara, Ono’s president, representative director, and CEO.
Tioga says that it expects to initiate Phase III development of asimadoline for D-IBS in the U.S. in the first quarter of 2010. The drug, which was discovered by Merck KGaA, was bought by Tioga in 2005.
Asimadoline is an orally administered small molecule that is a 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.