Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDI-31244 · 2 trials · 2 indications
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
The safety and the tolerability of single and multiple oral doses of CDI-31244 through number of AEs observed in HV and HCV infected subjects
| Arm | Type | Description |
|---|---|---|
| CDI-31244 + SOF/VEL | EXPERIMENTAL | CDI-31244 in combination with SOF/VEL |
| Cohort 1A HV | EXPERIMENTAL | CDI-31244 20 mg active or placebo single dose (SD) |
| Cohort 2A HV | EXPERIMENTAL | CDI-31244 50 mg active or placebo SD |
| Cohort 3A HV | EXPERIMENTAL | CDI-31244 100 mg active or placebo SD |
| Cohort 4A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo SD; food effect |
| Cohort 5A HV | EXPERIMENTAL | CDI-31244 400 mg active or placebo SD |
| Cohort 6A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo multiple dose (MD) |
| Cohort 7A HV | EXPERIMENTAL | CDI-31244 200 mg active or placebo MD |
| Cohort 8A HV | EXPERIMENTAL | CDI-31244 400 mg active or placebo MD |
| Cohort 1B HCV genotype (GT) 1 | EXPERIMENTAL | CDI-31244 400 mg active or placebo MD |
| Cohort 2B HCV GT 1 | EXPERIMENTAL | CDI-31244 600 mg active or placebo MD |
| Cohort 3B HCV GT 1 | EXPERIMENTAL | CDI-31244 800 mg active or placebo MD |
| Name | Type | Description |
|---|---|---|
| CDI-31244 | DRUG | investigational drug |
| SOF/VEL | DRUG | sofosbuvir and velpatasvir fixed dose combination |
| Placebo | DRUG | no active ingredients |
Key Inclusion Criteria: Documented chronic HCV GT 1 infection; Serum HCV RNA \>1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis Key Exclusion Criteria: Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of a...
CDI-31244 is an investigational small molecule being developed for the treatment of Hepatitis C and Chronic Hepatitis C. It is being studied in combination with other antiviral agents, specifically sofosbuvir and velpatasvir, for patients with chronic Hepatitis C infection.
CDI-31244 is being developed by Cocrystal Pharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol COCP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Hepatitis C.
CDI-31244 is currently in Phase 2 clinical development for Chronic Hepatitis C. A Phase 2 study evaluating the drug in combination with sofosbuvir and velpatasvir has been completed. The drug remains investigational and has not been approved by regulatory authorities.
CDI-31244 has been studied in two completed clinical trials. NCT02760758 was a Phase 1 study in healthy volunteers and Hepatitis C infected subjects in Canada. NCT03501550 was a Phase 2 study in the United States evaluating CDI-31244 in combination with sofosbuvir and velpatasvir for chronic Hepatitis C.
CDI-31244 is described as a novel NNI, which stands for non-nucleoside inhibitor, based on the title of its Phase 1 clinical trial. This class of drugs targets the Hepatitis C virus polymerase through a mechanism distinct from nucleoside inhibitors.