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Nidufexor

Phase 2

Diabetic Nephropathy | Small molecule | Other |Novartis AG|Last Updated: Aug 10, 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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03804879Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic NephropathyPHASE2 COMPLETED 83Dec 17, 2018May 3, 2021Aug 10, 202218 United States, Argentina +5
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Study Endpoints
Primary Endpoints
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR)
Baseline and days 14, 29, 57, 85, 113, 141 and 169

UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin \[mg/L\] / urine creatinine \[mmol/L\]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.

Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 (Day 169)
Baseline and day 169

Albuminuria describes the existence of albumin in the urine and the gold-standard to assess albuminuria is 24-hour urinary albumin excretion (milligram/24 hours). An analysis of covariance (ANCOVA) with treatment as the classification factor and log-transformed baseline as the covariate was conducted for log-transformed ratio to baseline 24-hour urinary albumin excretion. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to original scale. A lower score in the ratio to baseline indicates improvement.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From the start of treatment to 28 days after end of treatment, assessed up to maximum duration of 197 days

Number of participants with AEs and SAEs including significant changes from baseline in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs. The category Number of participants with AEs includes also the number of participants with SAEs. The number of participants in each category is reported in the table.

Secondary Endpoints
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR)
Baseline and days 14, 29, 57, 85, 113, 141 and 169
Maximum Peak Observed Concentration (Cmax) of LMB763
pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763
pre-dose and 1, 2, 4 and 6 hours after LMB763 administration on Day 1 and Day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LMB763EXPERIMENTAL50 mg LMB763 (two LMB763 25 mg capsules) were orally administered once daily for 24 weeks in addition to SoC.
PlaceboPLACEBO_COMPARATORPlacebo was orally administered once daily for 24 weeks in addition to SoC.
Interventions
NameTypeDescription
NidufexorDRUG50 mg (two 25 mg) LMB763 capsules for oral administration
PlaceboOTHERPlacebo capsules for oral administration
Standard of Care (SoC)DRUGOptimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Male/female patients, 18-75 years * Written informed consent * Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening * Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose ...

Countries:United StatesArgentinaCzechiaGermanyJordanLebanonTurkey (Türkiye)
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Competitive Landscape -Diabetic Nephropathy 8 trials