ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter - Seite 2

Based on the company’s analysis of the data, we believe these results should support filing our response to the FDA’s CRL. The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023. FDA did not provide guidance on a prespecified set of endpoints, but the data are anticipated to be informative to labeling if a second dose of neffy is needed.

ARS Pharma also completed the nitrosamine testing requested in the CRL per FDA’s draft guidance issued in August 2023, with no measurable levels of nitrosamines detected.

Previously reported data with a single dose of neffy under NAC conditions showed accelerated absorption of neffy with exposures higher than IM injection during the early time period when clinical response to epinephrine is expected.

“When a severe, life-threatening allergic reaction occurs, it is necessary to administer epinephrine as soon as possible. Based on the single dose NAC data, my allergy colleagues and myself already believed that neffy would be effective under NAC conditions. FDA asked what would happen if NAC conditions occurred during the 10% of anaphylaxis events that require a repeat dose of epinephrine,” says Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Translational Research in Allergy/Immunology at the University of South Florida in Tampa. “This study answers this question - exposures with repeat doses of neffy under NAC are at least as good as repeat doses of injection, and dosing in the same nostril is greater than injection. I believe the robust pharmacodynamic effect observed with repeat dosing in the same nostril or opposite nostrils compared to injection during nasal allergen challenge shows that neffy will be at least as effective as injection in reversing anaphylaxis symptoms, even during infrequently observed rhinitis of note. Together with the 100% response rate recently reported for neffy in treating pediatric oral food challenge-induced anaphylaxis, I believe this repeat dose NAC data provides further clinical evidence that neffy is effective under all relevant clinical conditions, and, if approved, supports its potential to provide an effective needle-free option for severe allergy patients and their families.”