Liver Efficacy Service Overview
Patient-derived MASH biology, dose-response, and a reference compound in every run
VivoSim Labs offers an integrated liver efficacy service built on the NAMkind™ MASH disease model — a fibrotic human liver in a 96-well plate. Safety kills individual candidates, but lack of efficacy kills whole programs: only about 8% of molecules entering Phase 1 reach launch, and efficacy failure is the single largest cause of attrition across Phase II and Phase III. A large share of that loss traces back to animal disease models that never reproduced the human disease in the first place.
Diet- and chemically-induced rodent MASH generates a phenotype that looks similar and behaves differently. The fibrogenic signaling, the immune composition and the drug metabolism are not human, which is why compounds that resolve rodent fibrosis routinely fail in patients. Inbred animals also hide the donor-to-donor variation that decides whether a drug works in a real population, and every design change costs another cohort, another quarter, another budget cycle.
The NAMkind™ MASH model puts your compound into human diseased liver tissue at the point where the decision is still cheap to change. Primary human hepatocytes from a healthy donor are co-cultured with primary non-parenchymal cells from a MASH donor — stellate, Kupffer and endothelial — producing steatotic, fibrogenic, collagen-depositing tissue rather than an induced approximation of it. Compounds are dosed repeatedly over 14 or 21 days with media exchange every other day, so the model reports chronic exposure rather than a 48-hour snapshot.
Every study runs your compound side by side with an approved or clinically validated reference on the same plate and in the same donor tissue. That single design choice converts “your assay produced a number” into “your compound was more or less active than resmetirom in the same human liver.” The deliverable is Excel raw data, interpreted slides, and a senior scientist walking your team through what the result means for the programs.
How the service works
From intake to final report, the workflow is built for speed and clarity. You ship the compounds; we culture NAMkind™ MASH spheroids, run the repeat-dosing schedule, collect the endpoint panel, and translate the data into a recommendation.
Studies start the week the compounds and the purchase order arrive — there is no campaign queue and no fixed monthly screening window. Interim status is visible on the customer portal throughout. The final report is issued three weeks after the last treatment.
Two-phase structure
Phase 1 — Pilot (optional) Two test articles at two concentrations. Spheroids are shipped back to your team for knockdown confirmation or PK analysis, so target engagement and anti-fibrotic effect come from the same material. Small enough to approve without a committee.
Phase 2 — Main study Full dose-response, four or more concentrations per target, with positive and negative controls on every plate.
Standard service timeline
Day -3 Spheroid formation and QC
Day 0 1st Dose
Weeks 3, 7, 10 Repeat dosing
Week 2 Harvest and endpoint collection
Weeks 3-5 Data Analysis
Week 5 Report and readout call
Human disease biology, not induced pathology
Clinically anchored on every plate
Chronic dosing, not a snapshot
No queue. Start the week the PO lands.
