Neurology · Neuromuscular disease
Your drug, measured.
From target engagement to function.
Prepoint™ by Usin’Life adds AI-driven digital endpoints — EEG, speech, movement, sleep and more — to your Phase 1 and runs them end to end, so your first human study answers Phase 2’s questions.
In neurology, measurement decides trial size.
Nine in ten drugs that enter clinical trials never reach patients, and lack of efficacy is the single biggest reason. The decision usually comes at Phase 2 — the evidence that decides it should be gathered in Phase 1. [Source 1]
In a simulation of ALS trials, detecting a 40% slowing of bulbar decline required 1,380 patients with the standard total score, and 336 with a subscale-based approach. The same drug effect, measured better, needs a trial a quarter of the size. [Source 2]
Regulators are ready: in 2023, a wearable measure became the first digital endpoint qualified by the European Medicines Agency as a primary endpoint in pivotal trials. [Source 3]
Prepoint: map, measure, predict.
Prepoint Map
Early access
Is your drug measurable? An asset-level assessment for biotech leaders, investors and business development teams.
Prepoint Measure
Available now
Digital endpoints built into your Phase 1 and run end to end, from design to decision. EEG, speech, gait, activity, sleep, fine motor, eye movements and more — connected to your biomarker data.
Prepoint Predict
In development
Forecast your Phase 2 from your Phase 1: projected effect size, sample size and duration.
Built into your workflow. Judged on results.
Where it fits
Inside your own Phase 1 protocol. One accountable team covers design, devices, operations, analysis and regulatory strategy.
How it’s judged
Against criteria set before the study starts: does the signal detect change earlier than the standard endpoint, how much does it shrink the projected Phase 2, and does it support a clear go/no-go?
AI can write a report. It can’t run your study.
New data from your patients — not only what’s already published.
Execution — devices, sites, compliance and data pipelines.
A decision — a go/no-go your board and investors can act on.
Regulatory-grade validation — built to FDA’s framework for digital measures.
We’ve done this in real trials.
ALS (case study)
Speech, mobility, sleep and activity endpoints across seven international sites. Speech measures detected decline before the standard rating scale. [Publication A]
Cancer cachexia
Digital endpoints aligned with FDA and EMA in a program that advanced from Phase 1 to Phase 3. [Publication D]
FSHD
Wearable endpoints in an international muscular dystrophy trial. [Publication F]
Start with one study.
Add Prepoint Measure to the Phase 1 you’re already planning, as an exploratory endpoint — low risk, clear criteria. Your data stays yours.