Nasus Pharma’s NS002 Hits 1.69-Minute Threshold, 88.4% Response at 5 Minutes
Nasus Pharma’s Phase 2 study of intranasal epinephrine NS002 showed a median time to 100 pg/mL blood epinephrine of 1.69 minutes versus 3.42 minutes for EpiPen, with 88.4% of NS002 subjects reaching threshold at 5 minutes compared to 64.6%. No serious adverse events occurred, and pivotal trials start in Q4 2026.
1. Phase 2 Study Design and Enrollment
The open-label Phase 2 trial enrolled 50 healthy adults with allergic rhinitis history, administering single and repeat doses of intranasal NS002 and intramuscular epinephrine autoinjector with and without a nasal allergic challenge to simulate real-world anaphylaxis conditions.
2. Pharmacokinetic Performance Advantages
NS002 achieved a median T100 of 1.69 minutes versus 3.42 minutes for the autoinjector (p=0.033); 67.4% of NS002 subjects hit therapeutic threshold at 2.5 minutes (27.1% for autoinjector, p=0.0001) and 88.4% at 5 minutes (64.6%, p=0.0081). Peak concentration occurred at 15 minutes versus 19.8 minutes with the autoinjector, and total early exposure was ~50% higher.
3. Safety Profile and Repeat Dose Findings
NS002 demonstrated a favorable safety and tolerability profile with no serious adverse events. Repeat dosing, even under nasal challenge, maintained pharmacokinetic advantages and comparable peak plasma concentrations, supporting potential need for multiple doses in severe anaphylaxis.
4. Next Steps and Pivotal Study Timeline
Nasus Pharma plans to initiate a pivotal Phase 3 trial in the fourth quarter of 2026. A conference call and webcast will review full analysis data and outline regulatory and development milestones toward marketing applications.