Nasus Pharma recently announced positive interim results from its Phase 2 clinical study of NS002, an investigational intranasal epinephrine powder for the treatment of anaphylaxis. The Tel Aviv-based clinical-stage pharmaceutical company reported that its needle-free alternative showed significantly faster absorption and higher peak epinephrine levels than the standard intramuscular EpiPen® auto-injector.
The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis, divided into two cohorts. The first group received either NS002 or an intramuscular EpiPen, with and without a nasal allergic challenge, while the second group received repeat doses to evaluate real-world scenarios where multiple administrations might be necessary. This comprehensive approach allowed researchers to compare the pharmacokinetic (PK) advantages of the powder formulation under conditions that mimic actual emergency situations.
According to the interim data, NS002 achieved a mean peak plasma concentration (Cmax) of 655 pg/ml, surpassing the 548 pg/ml recorded for the EpiPen. The intranasal powder reached its peak concentration (Tmax) in 10.8 minutes, compared with 15 minutes for the auto-injector. Most notably, 91% of participants using NS002 reached the critical epinephrine plasma threshold of 100 pg/ml within five minutes, a significant improvement over the 67% success rate with the EpiPen.
Safety remains a primary concern for emergency treatments, and the interim analysis indicated that NS002 was well-tolerated among all 50 subjects. No serious adverse events were reported, and the vast majority of treatment-emergent adverse events were mild, localized, and self-resolving. Additionally, the pharmacodynamic (PD) response—including changes in pulse rate and blood pressure—was found to be comparable to the EpiPen, remaining within a safe and normal range throughout the study.
Dr Michael Blaiss, a Clinical Professor of Allergy and Immunology and member of Nasus Pharma’s Scientific Advisory Board, highlighted the clinical importance of these speed advantages:
We believe these interim results are highly encouraging and reinforce the potential of NS002 as a meaningful advancement in anaphylaxis treatment. In anaphylaxis, outcomes are highly time-dependent, and delays in achieving effective pharmacologic action are associated with increased mortality. These pharmacokinetic advantages, combined with the needle-free administration, could help address the significant compliance challenges we see with current treatments.
Dan Teleman, Chief Executive Officer of Nasus Pharma, expressed confidence in the company’s proprietary Nasax® platform technology following the successful results. “The sustained performance of NS002 across single and repeat dosing scenarios – including under conditions simulating real-world allergic reactions – demonstrates the robustness of our proprietary Nasax platform technology,” Teleman said. He further emphasized that the company is “extremely pleased with these positive interim results,” which he believes validate NS002’s potential as a “first-in-class intranasal powder epinephrine product.”
Looking ahead, Nasus Pharma expects to release the full results of the Phase 2 study by the end of the first quarter of 2026. If the data remains consistent, the company plans to move forward with a pivotal clinical study slated to begin in the fourth quarter of 2026. This progression marks a major milestone for Nasus Pharma as it seeks to provide another reliable, needle-free alternative for the millions of people living with severe allergies.
