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news.Synergy Pharmaceuticals, a developer of new drugs to treat gastrointestinal disorders and diseases, has initiated dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC).
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Synergy Pharma said that SP-304 is a member of a new class of non-systemic drugs for treatment of chronic constipation (CC), irritable bowel syndrome with constipation (IBS-C) and other GI diseases. SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract.
Reportedly, the trial is a Phase IIa, randomised, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation. The objectives of the Phase IIa clinical trial with SP-304 are to characterise the safety of SP-304 for 14 days in patients with CC and establish doses for the larger planned Phase IIb trial in CC patients.
Gary Jacob, president and CEO of Synergy, said: “SP-304 offers hope to the millions of patients suffering from CC and other human gastrointestinal conditions, for which there are currently limited treatment options. The initiation of this trial is another major milestone in our development of this drug that we believe has the potential of delivering higher efficacy and a better safety profile than any other competitive product.”