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Nasus Pharma Advances NS002 Clinical Study

Nasus Pharma provided a business update highlighting recent Phase 2 results for NS002, its intranasal powder epinephrine product candidate for anaphylaxis. The company reported topline results demonstrating statistically significant improvements in time to therapeutic threshold compared to EpiPen. Nasus is advancing NS002 toward a pivotal clinical study expected to initiate in the Q4 of 2026. "Following the compelling topline Phase 2 results of NS002, we are advancing our intranasal epinephrine powder formulation towards a pivotal study planned to initiate in the fourth quarter of this year," said Dan Teleman, CEO of Nasus Pharma.

Nasus Pharma NS002 Clinical Trial Results Significantly Outperform EpiPen

Nasus Pharma announced top line results from its Phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. The comprehensive analysis demonstrated that NS002 achieved significantly faster and higher early epinephrine absorption compared to intramuscular EpiPen autoinjector. The Company plans to initiate its pivotal clinical study in fourth quarter of 2026. The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis. All subjects received a single and repeat dose of NS002 and intramuscular EpiPen with and without a nasal allergic challenge. This robust study design provided comprehensive data supporting NS002's clinical utility across multiple administration scenarios that patients may encounter during actual anaphylactic emergencies. Speed to Therapeutic Threshold: After a single administration, NS002 achieved the critical 100 pg/mL plasma epinephrine threshold with a median T100 of 1.69 minutes versus 3.42 minutes for EpiPen. At 2.5 minutes, 67.4% of participants receiving NS002 reached the therapeutic threshold compared to 27.1% with EpiPen. At 5 minutes, 88.4% of NS002 subjects reached the threshold compared to 64.6% with EpiPen. By 10 minutes, approximately 95% of participants receiving NS002 reached the therapeutic threshold. Time to Peak Concentration: NS002 reached peak concentration in a median of 15 minutes compared to 19.8 minutes with EpiPen, demonstrating consistently faster epinephrine delivery. Critical Window Drug Exposure: Total epinephrine absorption in the critical 10-minute therapeutic window following administration was approximately 50% higher with NS002, with AUC statistically significantly higher in the first 5-10 minutes compared to EpiPen. Repeat Dose Performance: Repeat administration of NS002 with or without a NAC maintained consistent pharmacokinetic advantages over EpiPen, a clinically significant finding given that patients experiencing severe anaphylaxis may require a repeat dose to fully resolve symptoms. Peak Plasma Concentrations: Across multiple scenarios, NS002 demonstrated comparable peak plasma concentration compared to EpiPen, with repeat dosing showing particularly strong performance. Safety and Tolerability Profile: NS002 demonstrated a favorable safety and tolerability profile consistent with previous studies, with no serious adverse events reported. These results demonstrated that NS002 has the potential to exceed EpiPen performance across the full spectrum of real-world conditions, including the challenging NAC environment that simulates scenarios patients may encounter during actual allergic reactions. The analysis showed statistically significant improvements in time to therapeutic threshold and in the proportion of subjects reaching the therapeutic epinephrine threshold within the first minutes following administration.