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CM-101

Phase 1

Nonalcoholic Steatohepatitis (NASH) | Small molecule | Infectious Disease |Chemomab Therapeutics Ltd.|Last Updated: Sep 14, 2023

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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06037577Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male SubjectsPHASE1 COMPLETED 8Mar 5, 2019May 5, 2019Sep 14, 20231 Israel
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Study Endpoints
Primary Endpoints
Incidence and characteristics of adverse events (AEs)
10 weeks

Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101

Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
10 weeks

Maximum CM-101 plasma concentration (Cmax)

Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
10 weeks

Time to Cmax (tmax)

Plasma pharmacokinetic (PK) of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
10 weeks

Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf

Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination rate constant (λz)
10 weeks

Terminal elimination rate constant (λz)

Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
10 weeks

Terminal elimination half-life (T½)

Secondary Endpoints
Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
10 weeks
Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
10 weeks
Level of antibodies
10 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Anti-human CCL24 monoclonal antibody (CM-101)EXPERIMENTALSingle 5 mg/kg of CM-101, Subcutaneous administration
PlaceboPLACEBO_COMPARATORPlacebo : Subcutaneous administration
Interventions
NameTypeDescription
CM-101DRUGAnti-human CCL24 monoclonal antibody (CM-101)
PlaceboDRUGPlacebo Comparator
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects must provide written informed consent prior to participating in the study. 2. Considered healthy by the Investigator as defined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG, and clinical labo...

Countries:Israel
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