Phase II

Phase II Endpoint and Model Review — NTX-101

Week 24 efficacy, responder analysis, and benchmarked predictive modeling for NTX-101 proof-of-concept evaluation.

Integrated report Program overview Data lineage Model review Phase I Phase II Phase III

Gate Decision: GO

Primary model metrics

Metric	Value
Threshold	0.494
ROC AUC	0.867
PR AUC	0.845
Brier	0.145
Sensitivity	0.806
Specificity	0.75
PPV	0.758
NPV	0.8
F1	0.781
N (test)	63
Responder diff (pp)	19.073
Gate decision	GO
Primary model	logistic_regression
Primary endpoint p-value	0.0019
Threshold rationale	Training ROC threshold maximizing specificity with sensitivity ≥ 0.78

Comparison	Mean difference	t-statistic	p-value	Approx CI
ntx101_low vs placebo	-0.188	-2.142	0.034	[-0.313, -0.064]
ntx101_high vs placebo	-0.266	-3.526	0.0006	[-0.355, -0.178]

Model	ROC AUC	PR AUC	Brier	F1
logistic_regression	0.868	0.845	0.145	0.781
elastic_net	0.867	0.845	0.146	0.794
random_forest	0.838	0.849	0.173	0.75