Achillion announces results from Phase 1 MAD study of ACH-5228
Achillion Pharmaceuticals announced results from their Phase 1 multiple ascending dose study with ACH-5228 outside of the United States. In the randomized Phase 1 MAD study, ACH-5228 was administered to 43 healthy volunteers. Study subjects received oral doses of ACH-5228 ranging from 40 mg to 200 mg twice a day for fourteen days. The study also included a single dose cohort of 240 mg. The results demonstrated that ACH-5228, when dosed 120 mg BID or higher, achieved near complete and sustained Alternative Pathway inhibition with a mean value of greater than95% at steady state concentrations as measured by AP Hemolysis and AP Wieslab assays. The study demonstrated that ACH-5228 was generally well tolerated over the dose ranges tested, which include the doses expected to be evaluated in Phase 2 trials. The Company expects to submit an IND application to the U.S. Food and Drug Administration supporting clinical development for ACH-5228 in the fourth quarter of 2019.