Clinical Execution Risk Assessment

Comprehensive operational risk analysis for clinical trials

This report summarizes Convexia's Science Agent analysis of Ensifentrine (OHT‑202), an inhaled dual PDE3/PDE4 inhibitor for COPD. Results are derived from integrated dual‑enzyme binding models, pulmonary PK/PD deposition simulations, safety projection analytics, and a trial‑execution digital twin—computed in hours on high‑performance GPUs.

OHT-202
COPD with chronic bronchitis • Phase III • Inhaled Small Molecule
72
High Risk
Countries: 15
Sites: 85
Duration: 24 months
Budget: $78,000,000

Molecular Details

Gene Symbol: PDE3A
UniProt ID: P27815
Structure Type: Small molecule
Mechanism: PDE3/4 inhibitor
Route: Inhalation

Trial Information

Study Design: Randomized, double-blind, placebo-controlled
Primary Endpoint: FEV1 AUC0-12h at Week 12
Patient Population: Moderate-to-severe COPD patients
Protocol Number: VER-202-301
ClinicalTrials.gov: NCT04636671

Selected CRO

Medpace Holdings Inc
Overall Execution Risk Assessment
Comprehensive analysis of operational factors affecting OHT-202 COPD trial success probability
72
Risk Score
Risk Component Analysis
Click each component to view detailed analysis, data sources, and recommendations
Critical API Supply Risk78/100

Single-source dependency on Primary API Supplier with 16-week lead time creates critical supply vulnerability

Site Activation Delays71/100

IRB/EC approvals averaging 75 days with only 18 of 85 planned sites activated at inflection point

Geographic Enrollment Risk65/100

Higher dropout rates anticipated in Eastern Europe and APAC regions based on digital twin modeling

Protocol Complexity Burden58/100

FEV1 endpoint optimization successful but visit schedule and spirometry requirements create patient burden

External Disruption Risk23/100

Low overall external risk with moderate geopolitical tensions in APAC region monitored

Recommended Actions
Prioritized interventions to reduce execution risk and improve trial success probability
Establish Secondary API SupplierCritical
Optimize Site Activation StrategyHigh