Sideris Terminates Chelator Trial
September 14, 2015 – Sideris Pharmaceuticals has announced that it has terminated its SP-420 development program. This Phase 1 study, entitled “Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia” (ClinicalTrials.gov identifier NCT02274233), was assessing safety and amount of the study drug in the blood after increasing doses of SP-420.
SP-420 is described as an orally active small molecule that selectively binds iron and removes it from the body.
The company terminated the study due to unexpected toxicity when the dose was escalated. Phase 1 trials are designed to determine possible safety issues early in the development of a drug. (Those interested in learning more about the purposes of clinical trials and how they work may want to participate in an upcoming FDA webinar on September 29, 2015 called “Get to Know ClinicalTrials.gov.”)