The Food and Drug Administration (FDA) has approved the investigational new drug application from Cocrystal Pharma for its experimental hepatitis C virus (HCV) drug CC-31244, clearing the way for a Phase IIa trial of the medication.
CC-31244 is a broad-spectrum nonnucleoside inhibitor that in earlier trials demontrated a high barrier to resistance, meaning hep C is unlikely to develop mutations associated with resistance to the drug during treatment. The medication is also active against all six genotypes of hep C and has shown a low level of toxicity in multiple types of cells.
The study, which is expected to begin by the end of June, will evaluate the safety, tolerability and preliminary efficacy of CC-31244 used in combination with approved hep C drugs. Participants will be treated for two to four weeks. The trial will primarily look at changes in hep C viral load, adverse health events and abnormal lab test results among the participants.
Cocrystal plans to report data from the study by the end of the year.
To read a press release about the study, click here.