Achillion Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug Application (IND) for ACH-5228, the Company’s second-generation oral factor D inhibitor. The opening IND study in the United States will be a drug-drug interaction study with ACH-5228. The Company expects to begin a Phase 2 proof-of-concept paroxysmal nocturnal hemoglobinuria (PNH) clinical trial of ACH-5228 in the first half of 2020. In a completed, randomized Phase 1 multiple ascending dose study, ACH-5228 was administered to 43 healthy volunteers outside of the United States. The results demonstrated that ACH-5228, when dosed at 120 mg or higher twice a day (BID), achieved near complete and sustained AP inhibition with a mean value of >95% at steady state concentrations as measured by AP Hemolysis and AP Wieslab assays. In the study, ACH-5228 was generally well-tolerated over the dose ranges tested, which included the doses expected to be evaluated in Phase 2 clinical trials.