ARS PHARMACEUTICALS, INC. The trial met its primary endpoints with both 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores as early as 5 minutes after dosing. Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
These data for neffy are being presented in an oral presentation today,
'The Phase 2 results in this highly refractory patient population are impressive and encouraging as they indicate neffy could be a game-changing therapeutic advance in the treatment of urticaria,' says
Design of neffy efficacy study in urticaria
The EPI-U01 study was a randomized, placebo-controlled, cross-over study evaluating the safety and efficacy of epinephrine nasal spray in patients with chronic spontaneous urticaria (CSU) treated with chronic medications who were still experiencing flares. This oral presentation includes data analysis from 18 adult patients as of the cut-off date who enrolled in this study and returned to the clinical site while experiencing a flare, where they were randomized to receive either a single treatment of 1 mg or 2 mg neffy or placebo in a crossover design.
All subjects had flares with pruritus and hives scores greater than or equal to 2 on a 3 point severity scale, despite all patients having been treated with antihistamines or Xolair.
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 ARS Pharma's planned urticaria outpatient study and the timing thereof; the potential pivotal study and the timing thereof; neffy potentially being a game-changing therapeutic advance in the treatment of urticaria and offering patients a treatment option to address existing gaps in the efficacy of currently available antihistamines or biologics; 1 mg dose of neffy potentially being sufficient to activate the beta-2 adrenergic receptors; the potential approval of neffy and the timing thereof 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,' 'could,' 'indicate,' 'may,' 'plans,' '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 results of the clinical trials 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
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.
Contact:
Email: Laura.oneill@finnpartners.com
Email: justinc@ars-pharma.com
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