Phase 1 clinical trial results show that CoCrystal Pharma’s CC-31244, a potential new therapy for hepatitis C virus (HCV) infections, meets the criteria to qualify for further testing.
The randomized, double-blind Phase 1a/1b study (NCT02760758) assessing the safety and tolerability of CC-31244 follows two groups: group A, in which 200 and 400 mg and single ascending doses (20, 50, 100, 200 and 400 mg) are tested in healthy volunteers; and group B, in which multiple doses are tested in people infected with HCV for seven days.
So far, the trial has dosed 42 healthy volunteers in group A and five HCV patients in group B.
Results showed no difference between the groups concerning the drug’s safety profile and in meeting the trial’s overall primary objectives, as both groups showed no signs of side effects or viral outbursts, and the drug seemed to accumulate only in the liver.
Treatment with 400 mg once daily of CC-31244 in HCV patients in group B revealed a substantial antiviral effect that was sustained. The HCV viral load in the patients was reduced substantially (three times compared to baseline levels) two days after the initiation of treatment. Participants also had a viral load still below baseline levels (about 1.9 times lower) a week after the treatment had finished.
CC-31244 is a pan-genotypic, potent NS5B non-nucleoside inhibitor (NNI); the drug blocks the activity of the NS5B protein, inhibiting viral replication.
“To date, CC-31244 appears to be safe and well tolerated in both healthy and HCV-infected subjects. This study is ongoing with additional cohorts and CoCrystal anticipates reporting the complete dataset by the first quarter of 2017,” Gary L. Wilcox, PhD, interim CEO of CoCrystal Pharma, said in a press release.
“Our initial clinical data are particularly encouraging. Our preclinical data indicate that the drug accumulates significantly in the liver,” said Sam Lee, PhD, co-inventor of the drug. “These data support the notion that CC-31244 is a potential best-in-class NNI which could be used as an important component in an all oral, ultra-short HCV combination therapy.”
According to the World Health Organization, from 130 million to 150 million people globally have chronic hepatitis C infection and of those, a substantial percentage will go on to develop cirrhosis of the liver or liver cancer.