Recent Updates
Recently added Catalysts

SOF

Phase 2

Chronic HCV Infection | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Mar 18, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03458481Phase 2 Study of Yimitasvir Phosphate CapsulesPHASE2 COMPLETED 129 — — Jul 31, 2017Sep 26, 2018Mar 18, 202017 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment

Safety and tolerability were evaluated based on adverse event monitoring, laboratory tests, 12-lead ECG assessments, vital signs measurements and physical examinations.
Up to posttreatment week 24
Secondary Endpoints
Percentage of subjects with sustained virologic response 4, 8 and 24 weeks after discontinuation of therapy (SVR4,SVR8 and SVR24)
Posttreatment Weeks 4,8 and 24
Percentage of subjects with HCV RNA < the lower limit of quantitation (LLOQ) while on treatment
Baseline to week 12
The time to first achieve "HCV RNA < the lower limit of quantitation (LLOQ)" while on treatment
Baseline to week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SOF+DAG181 100 mgEXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.
SOF+DAG181 200 mgEXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.
Interventions
NameTypeDescription
SOFDRUG400 mg tablet administered orally once daily
DAG181DRUGCapsule administered orally once daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: 1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. A female subject is eligible to enter the study if it is confirmed that she is: 1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed o...

Countries:China
Unlock Eligibility Criteria