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SAN DIEGO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today 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). The meeting will be held February 23-26, 2024, in Washington, DC.
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.
"I believe the robust and rapid clinical responses observed with neffy during anaphylaxis due to oral food challenge demonstrate that neffy is at least as effective as injection," says Motohiro Ebisawa, M.D., Ph.D., Director of Clinical Research Center for Allergy and Rheumatology at Sagamihara National Hospital, Past-President of the World Allergy Organization, and Principal Investigator of the study. "My allergy colleagues and I are eagerly awaiting regulatory approval of neffy, so that we can prescribe this needle-free and easy-to-carry treatment option to our severe allergy patients – many of whom do not carry, do not administer or delay use of epinephrine autoinjectors."
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.
"Epinephrine is the first-line treatment and only medication for anaphylaxis that reduces risk of hospitalization and death," says Sarina Tanimoto, M.D., Ph.D., Chief Medical Officer and Co-Founder of ARS Pharma. "The data from these studies to be presented at AAAAI in anaphylaxis and urticaria patients demonstrated that neffy worked as well and as fast as delivering epinephrine by injection, but without the need for a needle and its accompanying limitations."
ARS Pharma will share data across six presentations, further demonstrating the company's commitment to advancing its scientific leadership position in the allergy community. Additional neffy data to be presented include pharmacokinetic/ pharmacodynamic (PK/PD) effects in pediatric subjects, improved temperature stability versus injection products, improvements in patient quality of life, and increased device carriage, use and time to use rates.
Design of neffy efficacy study in oral food challenge induced anaphylaxis
This study (jRCT2031230143) assessed the safety and efficacy of a single dose of neffy given to pediatric patients with anaphylaxis symptoms induced by an oral food challenge.
2 mg (30 kg+ body weight) or 1 mg (15-30 kg body weight) doses of neffy were administered when patients exhibited gastrointestinal, respiratory or circulatory symptoms that were grade two or higher on the three-grade scale in the Severity Classification of Organ Symptoms by the Japanese Society of Allergology Anaphylaxis Guidelines 2022.1
Results from neffy efficacy study in oral food challenge induced anaphylaxis
A total of 15 patients aged 6 to 17 were enrolled; 6 subjects (15-30 kg body weight) were dosed with 1 mg neffy, and 9 subjects (30 kg+ body weight) 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.
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.
ARS Pharma remains on track to announce topline results from its repeat dose study of neffy under nasal allergen challenge conditions in the first quarter of 2024 and re-submit its NDA mid-first half of 2024 with an expected PDUFA action date and US launch, if approved, in the mid-second half of 2024.
The neffy presentations at AAAAI are listed below:
neffy clinical efficacy studies
Title: neffy, epinephrine nasal spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at-Risk of Anaphylaxis: Phase 3 Study Results
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Session: Late-Breaking Poster Session II
Location: Convention Center, Level 2, Hall D
Title: ARS-2, Low-Dose Intranasal Epinephrine, Improves Urticaria Scores in Patients with Frequent Urticaria Flares: Phase 2 Study Results
Date & Time: Monday, February 26, 2024 12:45 to 2:00 p.m. ET
Poster Number: 788
Session: Novel Insights into Urticaria/Angioedema/Atopic Dermatitis
neffy PK/PD and product formulation studies
Title: Pediatric Doses of neffy (Intranasal Nasal Spray) Demonstrate Pharmacokinetic Profiles That Are Equivalent to Epinephrine Injections Products
Date & Time: Friday, February 23, 2024, 3:15 to 4:15 p.m. ET
Poster Number: 033
Location: Convention Center, Level 2, Hall D
Title: Comparative Stability of Three Epinephrine Products Under Extreme Temperature Conditions
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Number: L32
Location: Convention Center, Level 2, Hall D
neffy real-world patient burden studies
Title: Effect of Needle-Free Epinephrine on Food Allergy Patient and Caregiver Quality of Life
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Number: 240
Location: Convention Center, Level 2, Hall D
Title: A Survey of Allergists, Pediatricians, and Primary Care Physicians About the Utilization of Epinephrine
Date & Time: Saturday, February 24, 2024, 9:45 to 10:45 a.m. ET
Poster Number: 299
Location: Convention Center, Level 2, Hall D
About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.
Posted In: SPRY
