ARS Pharmaceuticals to present efficacy data for neffy at 2024 AAAAI meeting

ARS Pharmaceuticals announced that new clinical data, including efficacy outcomes supporting neffy, epinephrine nasal spray, will be presented during the 2024 American Academy of Allergy, Asthma and Immunology, AAAAI. One late-breaking presentation reports efficacy outcomes for the first time with neffy in pediatric patients who developed anaphylaxis symptoms following oral food challenge. The efficacy data demonstrated that 100% of patients responded to a single dose of neffy with a 16-minute median time to complete resolution of anaphylaxis symptoms. A second presentation details the statistically significant and clinically meaningful reductions in urticaria symptoms achieved by neffy across all endpoints in its randomized, controlled proof-of-concept study. Results from neffy efficacy study in oral food challenge induced anaphylaxis: A total of 15 patients aged 6 to 17 were enrolled; 6 subjects were dosed with 1 mg neffy, and 9 subjects were dosed with 2 mg neffy. Treatment guidelines indicate a second dose of epinephrine should be given if clinical response is not observed within the first 15 minutes. 100% of the patients responded to the single dose of neffy. After dosing neffy, the median time to complete resolution of anaphylaxis symptoms was 16 minutes.1 of 15 patients experienced a biphasic reaction 2 hours and 45 minutes following complete resolution of symptoms with the single dose of neffy and required additional epinephrine treatment. For epinephrine injection products, biphasic reactions are reported to occur at a frequency of 12.8% in children with food-induced anaphylaxis. For epinephrine injection products, two or more doses of epinephrine are required for 10.8% of oral food challenges treated with epinephrine. Clinical data in this neffy trial is therefore in line with historical clinical response data for injection products. The trial demonstrated safety results similar to the previously reported safety profile of neffy and approved epinephrine products with adverse events reported in 7 subjects dosed with neffy, all of which were mild or moderate and most of which resolved quickly.