The meeting is being held
Presentations will highlight clinical data from a rigorous registration program for neffy 2.0 mg of more than 600 subjects, including analyses of patients with upper respiratory tract infections, pediatric patients 30 kg with a history of type I allergic reaction, patients with allergen-induced allergic rhinitis and the relationship between body weight/BMI and epinephrine exposure.
Notably, data demonstrate that the pharmacokinetics of neffy are independent of BMI or body weight. Unlike injection products where exposures decreased with varying BMI or body weight, neffy could be a potentially effective epinephrine product in these patients. These results will be presented as a Distinguished Industry Oral Abstract on
'At ARS Pharma, we are committed to advancing much-needed science in allergic diseases to make a positive impact on the people and communities we serve. To that end, we are pleased to share these clinical data that provide critical insights into neffy's potential as the first intranasal medicine for treating severe allergic reactions,' said
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
About
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy (previously referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis.
Forward-Looking Statements
Statements 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 for neffy to be a safe and effective option across patient sub-populations, including pediatric patients and patients experiencing upper respiratory tract infections; the potential for neffy to be a more effective epinephrine alternative to injection products in patients with elevated body weight of BMI and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'plans,' 'expects,' 'will,' 'potential' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the ability to obtain and maintain regulatory approval for neffy; the ability to successful complete the repeat-dose study under allergen-induced allergic rhinitis conditions on the timeframe anticipated, as a result of challenges inherent to enrolling, conducting and completing clinical trials; the results of the repeat-dose study under allergen-induced allergic rhinitis conditions may not support the approval of neffy; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labelling 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 outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended
Contact:
Email: sherryk@ars-pharma.com
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