Tioga Pharmaceuticals Raises $10 Million to Continue Phase III Development of IBS Drug
Published: Apr 13, 2012
Tioga is currently conducting a Phase 3 trial of its compound, asimadoline, for the treatment of diarrhea-predominant irritable bowel syndrome (D-IBS) under a special protocol assessment with the U.S. Food and Drug Administration (FDA). The 600-subject randomized, double-blind, placebo-controlled clinical trial is one of two registration trials required for approval in the U.S. Asimadoline has also been granted Fast Track designation by the FDA for the treatment of D-IBS.
Stuart Collinson, Ph.D., chairman and chief executive officer of Tioga, said, "We welcome Jason Brown as an investor and board member at an exciting time for Tioga as we advance asimadoline's Phase 3 program. The program has a clear and expedited regulatory path, and a long patent life."
"Tioga marks our third new investment in Southern California since we opened our San Diego office last year, and is a great example of the continuing growth of life sciences in the region," said Dr. Brown. "Asimadoline is an attractive, novel, late-stage medicine that has the potential to fulfill the substantial unmet need in D-IBS. It has demonstrated impressive efficacy in D-IBS patients, and an excellent safety profile in more than 1,100 subjects."
In September 2009, Ono Pharmaceutical Co., Ltd. licensed exclusive rights from Tioga to develop and commercialize asimadoline in Japan, South Korea and Taiwan. Tioga retains all other rights to the compound.
In a 596-subject Phase 2b clinical trial asimadoline demonstrated statistically significant results in the treatment of D-IBS patients with at least moderate pain across multiple parameters including endpoints of pain, urgency, frequency and bloating in both males and females. A therapeutic benefit was observed within the first month of treatment and was sustained for the three month duration of the trial. Asimadoline was well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial. Asimadoline is protected by an extensive worldwide patent estate. This includes a recently issued U.S. patent claiming the use of asimadoline for the treatment of D-IBS, which expires in 2028.
Asimadoline is an agonist of the kappa opioid receptor with high selectivity over other opioid receptors such that it does not produce classical mu-opioid like effects (such as constipation and dependence). Asimadoline is administered orally and is thought to act within the gut wall to inhibit sensory nerves that transmit pain signals and enteric nerves that regulate bowel movements. Preclinical studies show that expression of kappa-opioid receptors is increased in visceral hypersensitivity, which is common in D-IBS patients. Asimadoline may act upon this up-regulated kappa-opioid receptor system to inhibit the effects of visceral hypersensitivity, thus inhibiting pain and reducing overactive bowel function.
Tioga Pharmaceuticals, Inc. is a pharmaceutical company headquartered in San Diego, CA focused on developing novel treatments for gastrointestinal diseases. For more information, please visit: www.tiogapharma.com.
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SOURCE Tioga Pharmaceuticals, Inc.