RA Pharmaceuticals initiates dosing in Phase 1b clinical study of RA101495 SC
Ra Pharmaceuticals announced that it has initiated dosing in the company's Phase 1b clinical trial evaluating RA101495 SC in patients with renal impairment. This trial is designed to characterize the pharmacokinetics of RA101495 SC in these patients, thereby enabling the evaluation of RA101495 SC in complement-mediated renal diseases, such as atypical hemolytic uremic disorder and lupus nephritis. Ra Pharma is a clinical stage biopharmaceutical company focusing on the development of next-generation therapeutics for the treatment of complement-mediated diseases and is developing RA101495 as a novel, subcutaneously-administered inhibitor of complement component 5. RA101495 SC is currently in Phase 2 clinical development for the treatment of paroxysmal nocturnal hemoglobinuria and generalized myasthenia gravis. The Phase 1b, multi-center, open-label trial is designed to evaluate the PK profile of RA101495 SC in patients with renal impairment. The trial is planned to enroll approximately 16 subjects, including eight patients with severe renal impairment matched with eight healthy control subjects with normal renal function. Each patient will receive a single, SC dose of 0.3 mg/kg of RA101495. The trial will compare the PK profile in patients with renal impairment with subjects with normal renal function.