Ongoing study with asimadoline in D-IBS patients is one of two required for U.S. registration.
Tioga Pharmaceuticals raised $10 million in a Series B equity financing round led by new investor, Thomas, McNerney & Partners. The firm will use the funds to continue Phase III development of its kappa opioid receptor agonist asimadoline in the treatment of diarrhoea-predominant irritable bowel syndrome (D-IBS), under a special protocol assessment with FDA. The ongoing Phase III study in 600 patients is one of two registrational trials that will be needed for registration of the drug in the U.S.
Tioga was established as a spin-out from Merck KGaA in 2005 to develop asimadoline as an oral treatment for IBS. In 2009 Ono Pharmaceuticals negotiated rights to develop and commercialize asimadoline in Japan, South Korea, and Taiwan.
The drug is believed to act within the gut wall to inhibit sensory nerves that transmit pain signals and enteric nerves that regulate bowl movements. A previously completed Phase IIb study in 596 IBS patients showed that treatment with oral asimadoline resulted in significant improvements in a number of parameters including pain (the primary endpoint), urgency, frequency, and bloating.
