Data will be presented in four oral and poster presentations at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting
Supports Neffy potential to be a safe and effective option in patient subpopulations based on data including the relationship between BMI/body weight and epinephrine exposure, congestion/rhinitis during infection upper respiratory tract and pediatrics
SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from allergic reactions serious which can lead to anaphylaxis. , announced today that clinical data supporting neffy (epinephrine nasal spray) will be presented at the 2023 American College of Allergy Asthma and Immunology (ACAAI) Annual Scientific Meeting. The meeting will be held November 9-13, 2023 in Anaheim, California.
Presentations will highlight clinical data from a rigorous registration program for neffy 2.0 mg from over 600 subjects, including analyzes of patients with upper respiratory infections, pediatric patients ≥ 30 kg with a history of type I allergic reaction, patients with allergic rhinitis induced by allergen and the relationship between body weight/BMI and epinephrine exposure. .
In particular, the data demonstrate that the pharmacokinetics of neffy are independent of BMI or body weight. Unlike injectable products for which exposure decreased with variation in BMI or body weight, neffy could be a potentially effective epinephrine product in these patients. These findings will be presented as a distinguished industry oral summary on Saturday, November 11 at 4:30 p.m. Pacific Time (Session A).
“At ARS Pharma, we are committed to advancing much-needed science in the field of allergic diseases to positively impact the people and communities we serve. To this end, we are pleased to share this clinical data which provides essential information on Neffy potential as the first intranasal drug to treat severe allergic reactions,” said Sarina Tanimoto, MD, Ph.D., chief medical officer and co-founder of ARS Pharma. “Severe allergic reactions can be life-threatening, and the current standard of care relies on needle-based injectable devices associated with many administration issues. The data generated supports that neffy achieves a PK/PD profile comparable to injectables in various patient subgroups while potentially allowing patients to easily transport and confidently administer epinephrine, without hesitation or anxiety.
Details of the presentations are as follows:
Title: Acute allergic rhinitis increases endogenous epinephrine, leading to increased heart rate
Date and hour : Friday, November 10 at 4:30 p.m. PT
Session: Adverse drug reactions, insect reactions, anaphylaxis
Summary of data: Acute allergic rhinitis induces an increase in circulating endogenous epinephrine and heart rate, possibly in response to changes in blood flow distribution.
Title: A Single Period, Single Dose Study of Epinephrine Pharmacokinetics Following Administration of ARS-1 to Pediatric Subjects
Date and hour : Friday, November 10 at 5:45 p.m. PT
Session: Adverse drug reactions, insect reactions, anaphylaxis
Summary of data: The pharmacokinetic profile of neffy The 2.0 mg dose in pediatric allergic subjects is comparable to that seen in adults and is expected to be a safe and effective option for the treatment of type I allergic reactions (including anaphylaxis) in pediatric subjects.
Title: Integrated pharmacokinetic-pharmacodynamic analysis: effect of weight and BMI on epinephrine concentration
Date and hour : Saturday, November 11 at 4:30 p.m. PT
Session: Distinguished Industry Oral Summaries – Session A
Summary of data: Based on the rigorous registration program of neffy, the presentation will address the question of what effect body weight and BMI have on epinephrine absorption. Intramuscular and subcutaneous injections have a negative relationship with epinephrine exposure, while neffy does not. This suggests neffy could be a potentially more effective alternative to epinephrine than injectables in patients with high body weight or BMI.
Title: Effect of Upper Respiratory Tract Infection on the Pharmacokinetics of Intranasal Epinephrine
Date and hour : Adverse drug reactions, insect reactions, anaphylaxis
Session: Sunday, November 12 at 11:35 a.m. PT
Summary of data: Absorption of epinephrine via neffy 2.0 mg for viral upper respiratory tract infection did not have a significant impact on pharmacokinetics and pharmacodynamics. neffy 2.0 mg is expected to be a safe and effective option for the treatment of type I allergic reactions (including anaphylaxis) in patients with upper respiratory infections.
About type I allergic reactions, including anaphylaxis
Severe Type I allergic reactions are serious, 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. Although epinephrine auto-injectors have been shown to be very effective, there are well-published limitations that lead many patients and caregivers to delay or not administer treatment in an emergency. These limitations include fear of the needle, lack of portability, needle safety concerns, unreliability, and device complexity. In the United States, approximately 40 million people suffer from severe type I allergic reactions. Of these, only 3.3 million currently have an active epinephrine auto-injector prescription, and of those, only half systematically carry the prescribed auto-injector with them. Even if patients or caregivers carry an auto-injector, more than half delay or do not administer the device in an emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves against severe allergic reactions that can lead to anaphylaxis. The Company develops neffy® (previously called ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions, including foods, drugs, and insect stings that can lead to life-threatening anaphylaxis . For more information, visit www.ars-pharma.com.
Forward-looking statements
Statements contained in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the potential neffy be a safe and effective option for patient subpopulations, including pediatric patients and patients with upper respiratory infections; the potential of neffy be a more effective alternative to epinephrine injectables in patients with high body weight and BMI; and other statements that are not historical facts. Because these statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by these forward-looking statements. Words such as “anticipate,” “project,” “expect,” “will,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on ARS Pharma’s current expectations and involve assumptions that may never materialize or prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements due to various risks and uncertainties, which include, without limitation, the ability to obtain and maintain regulatory approval for neffy; the ability to successfully complete the repeat-dose study under allergen-induced allergic rhinitis conditions within the anticipated time frame, due to the challenges inherent in recruiting, conducting and completing clinical trials; results from the repeated dose study under allergen-induced allergic rhinitis conditions may not support approval of neffy; clinical trial results may not be indicative of results that may be observed in the future; potential safety and other complications due neffy; labeling for neffy, if approved; ARS Pharma’s ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual results to differ materially from those contemplated in the forward-looking statements are included under the heading “Risk Factors” in ARS Pharma’s Quarterly Report on Form 10-Q for the completed quarter. on June 30, 2023. , filed with the Securities and Exchange Commission on August 10, 2023. This document is also accessible on the ARS Pharma web page at ir.ars-pharma.com by clicking on the link “Financials & Filings”.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements except as required by law.
ARS Pharma media contacts:
Sherry Korczynski
ARS Pharmaceutical
sherryk@ars-pharma.com
ARS Pharma investor contacts:
Justin Chakma
ARS Pharmaceutical
justinc@ars-pharma.com
