Biolevate Agent Test Document

Project: Project Helios - Phase II clinical study readout

Summary:
Project Helios is a Phase II, randomized, double-blind study evaluating
Biolevate-101 versus placebo in 240 adult patients over 24 weeks.

Key facts:
- Primary endpoint: change in symptom severity score at week 24.
- The Biolevate-101 high-dose arm met the primary endpoint (p=0.004).
- The most common adverse events were mild headache and nausea.
- No serious treatment-related adverse events were reported.
- The study was conducted across 18 sites in 4 countries.

Risks and caveats:
- The open-label extension is still ongoing, so long-term safety data are limited.
- The placebo response was higher than expected, which may affect interpretation.

Conclusion:
The data support advancing Biolevate-101 to a confirmatory Phase III trial.
