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KAF156

Phase 2

Malaria | Small molecule | Infectious Disease |Novartis AG|Last Updated: Aug 28, 2019

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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01753323Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infectionPHASE2 COMPLETED 43 — — Mar 1, 2013Aug 1, 2014Jun 7, 20185 Thailand, Vietnam
NCT04072302Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge ModelPHASE1 COMPLETED 86 — — Sep 15, 2014Nov 29, 2017Aug 28, 20191 United States
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Study Endpoints
Primary Endpoints
Time to Parasite Clearance
Day 5

Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.

28-day Cure Rate - Part 2
Day 28

28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.

Number of subjects with parasitemia after single dose oral administration of KAF156 either prior to, or following, exposure to P. falciparum sporozoite-infected mosquitoes
From Day 1 to Day 43

The number of subjects that became infected with malaria at each dose

Relationship between pharmacokinetics (i.e., Maximum Plasma Concentration [Cmax], Area Under Curve [AUC]) of KAF156 and number of subjects with parasitemia, after oral administration of single descending doses of KAF156 in healthy subjects with CHMI
From Day 1 to Day 43

The exposure-response relationship of KAF156 was explored in a PK/PD model to relate drug exposure to prophylactic efficacy using standard statistical methods such as CART or non-linear regression. Summary statistics were also provided for the malaria incidence rate by cohort and treatment arm

Secondary Endpoints
Area Under the Curve (AUC)0-24h - Part 1
Days 1 and 3
Maximum Concentration (Cmax) - Part 1
Days 1 and 3
Time to Maximum Concentration (Tmax) - Part 1
Days 1 and 3
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 - Cohort 1: P. vivax: KAF156 400mg QDEXPERIMENTALParticipants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
Part 1 - Cohort 2: P. falciparum: KAF156 400mg QDEXPERIMENTALParticipants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
Part 2 - Cohort 3: P. falciparum: KAF156 800mg single doseEXPERIMENTALParticipants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
KAF156 800 mg pre-challengeEXPERIMENTALSingle dose 800 mg KAF156 oral administration in healthy subjects, prior to exposure to P. falciparum sporozoite-infected mosquitos
Placebo 800 mg pre-challengePLACEBO_COMPARATORSingle dose 800 mg placebo oral administration in healthy subjects, prior to exposure to P. falciiparum sporozoite-infected mosquitos
KAF156 800 mg post-challengeEXPERIMENTALSingle dose 800 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo 800 mg post-challengePLACEBO_COMPARATORSingle dose 800 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156 300 mg post-challengeEXPERIMENTALSingle dose 300 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo 300 mg post-challengePLACEBO_COMPARATORSingle dose 300 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156 100 mg post-challengeEXPERIMENTALSingle dose 100 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo 100 mg post-challengePLACEBO_COMPARATORSingle dose 100 mg placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156 20 mg post-challengeEXPERIMENTALSingle dose 20 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo 20 mg post-challengePLACEBO_COMPARATORSingle dose 20 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
KAF156 50 mg post-challengeEXPERIMENTALSingle dose 50 mg KAF156 oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Placebo 50 mg post-challengePLACEBO_COMPARATORSingle dose 50 mg Placebo oral administration in heatlhy subjects, after exposure to P. falciparum sporozoite-infected mosquitos
Interventions
NameTypeDescription
KAF156DRUGKAF156 was supplied as tablets for oral use.
PlaceboDRUG100 mg tablet, 20 mg tablet, 50 mg tablet
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Eligibility Criteria
Age Range20 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: -Male and female patients aged 20 to 60 years;Presence of mono-infection of P. falciparum or P. vivax; Weight between 40 kg to 90 kg. Exclusion Criteria: * Patients with signs and symptoms of severe/complicated malaria * Infection with more than one parasite species * Women of...

Countries:ThailandVietnamUnited States
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Competitive Landscape -Malaria 8 trials
CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
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