Tioga Pharmaceuticals, Inc has reached agreement with the US Food and Drug Administration (FDA) on Special Protocol Assessments (SPAs) for the phase-3 efficacy protocols for its product candidate, asimadoline, for the treatment of patients with diarrhoea-predominant irritable bowel syndrome (D-IBS). The SPAs represent agreement with US FDA on the design, execution and analysis of the two planned phase-3 trials required for product registration. Tioga and US FDA agreed upon the patient population to study; dosage; primary and secondary endpoints and their analyses; inclusion and exclusion criteria; study duration; and evaluations to be performed during the studies, among other items.
“We are very pleased with the agreement reached with US FDA for the SPAs and believe it represents a significant step forward for both Tioga as well as the field of IBS,” said Allen Mangel, consulting chief medical officer for Tioga. Currently there is only one drug approved in the US for D-IBS patients, but due to safety concerns its use is restricted to female patients with severe cases and it is administered under a risk management programme. Tioga’s goal is to develop a safe and effective therapy for the nine million patients suffering from this condition in the US.
Tioga plans to initiate the first of two registration trials required for US approval later this month at 120 sites in the US. Each trial will be a 600-subject, randomized, double-blind, placebo-controlled, singledose clinical study to evaluate the safety and efficacy of asimadoline for the treatment of patients with DIBS.
Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted,
kappa opioid receptor agonist.
Tioga Pharmaceuticals is a pharmaceutical company headquartered in San Diego, CA focused on developing novel treatments for gastrointestinal diseases.