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NOV-205

Phase 2

Hepatitis C | Small molecule | Infectious Disease |Cellectar Biosciences, Inc.|Last Updated: Jul 25, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01058512A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard TherapyPHASE2 COMPLETED 22 — — Mar 1, 2010Dec 1, 2010Jul 25, 20226 United States
NCT00372983Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard TherapyPHASE1 COMPLETED 30 — — Aug 1, 2006Dec 1, 2007Dec 21, 2007 - —
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Study Endpoints
Primary Endpoints
To evaluate changes in viral load
16 months
To evaluate changes in serum ALT and AST levels
16 months
To evaluate the durability of any changes in viral load and serum ALT and AST
16 months
To establish the safety profile of NOV-205
16 months
To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.
To establish the safety profile of NOV-205 in comparison to that of placebo.
To compare changes in viral load after treatment with NOV-205 or placebo (as evidenced by a quantitative reduction of >0.5 log10 in serum HCV RNA levels by quantitative analysis as compared to the average of the screening and baseline values).
To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SingleEXPERIMENTALsingle-arm study
Interventions
NameTypeDescription
NOV-205DRUGThere will be 4 treatment Groups with 10 patients in each group: * Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days * Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days * Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days * Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * A serum HCV RNA level of \>100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = \~650 IU/ml) or other equally sensitive quantitative methods. * Infection with genotype 1 HCV * Documented failure to respond to treatment (defin...

Countries:United States
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Competitive Landscape -Hepatitis C 11 trials
CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir
Abbott LaboratoriesABT2 — Undisclosed
AbbVie, Inc.ABBV1 — Undisclosed
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