Nasus Pharma just lately introduced optimistic interim outcomes from its Part 2 scientific research of NS002, an investigational intranasal epinephrine powder for the remedy of anaphylaxis. The Tel Aviv-based clinical-stage pharmaceutical firm reported that its needle-free different confirmed considerably quicker absorption and better peak epinephrine ranges than the usual intramuscular EpiPen® auto-injector.
The open-label Part 2 research enrolled 50 wholesome adults with a historical past of allergic rhinitis, divided into two cohorts. The primary group obtained both NS002 or an intramuscular EpiPen, with and with no nasal allergic problem, whereas the second group obtained repeat doses to guage real-world situations the place a number of administrations is likely to be crucial. This complete strategy allowed researchers to match the pharmacokinetic (PK) benefits of the powder formulation beneath circumstances that mimic precise emergency conditions.
In keeping with the interim information, NS002 achieved a imply peak plasma focus (Cmax) of 655 pg/ml, surpassing the 548 pg/ml recorded for the EpiPen. The intranasal powder reached its peak focus (Tmax) in 10.8 minutes, in contrast with quarter-hour for the auto-injector. Most notably, 91% of members utilizing NS002 reached the vital epinephrine plasma threshold of 100 pg/ml inside 5 minutes, a major enchancment over the 67% success price with the EpiPen.
Security stays a main concern for emergency remedies, and the interim evaluation indicated that NS002 was well-tolerated amongst all 50 topics. No severe antagonistic occasions have been reported, and the overwhelming majority of treatment-emergent antagonistic occasions have been delicate, localized, and self-resolving. Moreover, the pharmacodynamic (PD) response—together with adjustments in pulse price and blood strain—was discovered to be similar to the EpiPen, remaining inside a protected and regular vary all through the research.
Dr Michael Blaiss, a Scientific Professor of Allergy and Immunology and member of Nasus Pharma’s Scientific Advisory Board, highlighted the scientific significance of those velocity benefits:
We imagine these interim outcomes are extremely encouraging and reinforce the potential of NS002 as a significant development in anaphylaxis remedy. In anaphylaxis, outcomes are extremely time-dependent, and delays in reaching efficient pharmacologic motion are related to elevated mortality. These pharmacokinetic benefits, mixed with the needle-free administration, may assist handle the numerous compliance challenges we see with present remedies.
Dan Teleman, Chief Government Officer of Nasus Pharma, expressed confidence within the firm’s proprietary Nasax® platform know-how following the profitable outcomes. “The sustained efficiency of NS002 throughout single and repeat dosing situations – together with beneath circumstances simulating real-world allergic reactions – demonstrates the robustness of our proprietary Nasax platform know-how,” Teleman stated. He additional emphasised that the corporate is “extraordinarily happy with these optimistic interim outcomes,” which he believes validate NS002’s potential as a “first-in-class intranasal powder epinephrine product.”
Wanting forward, Nasus Pharma expects to launch the complete outcomes of the Part 2 research by the tip of the primary quarter of 2026. If the information stays constant, the corporate plans to maneuver ahead with a pivotal scientific research slated to start within the fourth quarter of 2026. This development marks a significant milestone for Nasus Pharma because it seeks to supply one other dependable, needle-free different for the tens of millions of individuals dwelling with extreme allergy symptoms.
