ARS Pharmaceuticals Announces Presentation of Clinical Data Supporting neffy® (Epinephrine Nasal Spray) for the Treatment of Allergic (Type I) Reactions, Including Anaphylaxis

Data from pivotal clinical trials will be presented in five poster presentations at the 2022 American College of Allergy, Asthma and Immunology Annual Scientific Meeting

The data supports the new drug application for neffy®currently under review with the US FDA

SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves against severe allergic reactions that can lead to anaphylaxis, announced today that positive clinical data confirming neffy® (previously called ARS-1), the first potential non-injectable drug for the treatment of allergic (Type I) reactions, including anaphylaxis, will be presented at the 2022 American College of Allergy Asthma and Immunology Annual Scientific Meeting (ACAAI). The meeting will be held November 10-14, 2022 in Louisville, Kentucky.

Presentations will highlight the results of several clinical trials of neffy (EPI-15 and EPI-16) that were included in the company’s New Drug Application (NDA) for neffy as emergency treatment of allergic (Type I) reactions, including anaphylaxis in adults and children ≥ 30 kg (66 lb). The United States Food and Drug Administration (FDA) has accepted the NDA for neffy for review with a Prescription Drug User Fee Act (PDUFA) target action date of mid-2023.

Data from the EPI-15 and EPI-16 clinical trials demonstrated that neffy provided consistent epinephrine levels to achieve the pharmacokinetic (PK) profile within the PK range of approved intramuscular (IM) injection products in normal and rhinitis conditions. In addition, by neffy Pharmacodynamic (PD) profile, the surrogate measure to assess clinical efficacy in anaphylaxis (e.g., increase in blood pressure, heart rate), has demonstrated comparable or superior PD response to currently available IM injectable products approved. These data also provide important insight into the mechanism of action of intranasal epinephrine. The ARS will also present the results of a survey of doctors and caregivers, which suggests that patients and caregivers have a preference for a needle-free alternative to epinephrine and would dose neffy earlier during an allergic reaction without the hesitation caused by fear of the needle and pain.

“We are pleased to share these data from two of our leading clinical trials to neffyboth of which provide essential information on by neffy potential as the first intranasal drug for the treatment of severe allergic reactions,” said Richard Lowenthal, M.Sc., MSEL, co-founder and CEO of ARS. “Severe allergic reactions can be life-threatening, and the current standard of care is needle-injectable devices with many administration challenges. All of the data generated confirms that neffy achieves a PK/PD profile comparable to injectables, while potentially offering patients a safe, effective, and easy-to-administer, needle-free, no-wait option to approved epinephrine injection devices. With our NDA currently under review by the FDA, we are committed to partnering with the Agency and advocacy groups to ensure we can bring neffy patients with type I allergic reactions and their caregivers.

The details of the presentations are as follows:

Title: Pharmacokinetics/Pharmacodynamics after single and repeated administration of ARS-1,
Epinephrine auto-injector and manual intramuscular injection (EPI-15)
Date and hour : Friday, November 11 at 5:30 p.m. ET
Session: Other anaphylaxis
Summary of data: Following pharmacokinetic profile neffy 2.0 mg is within the range of currently approved injection products. by neffy pharmacodynamic profile is comparable or superior to that of EpiPen or manual injection, suggesting that neffy may be at least as effective as these approved products.

Title: Pharmacokinetics and pharmacodynamics of ARS-1 and manual intramuscular injection
in subjects with/without allergic rhinitis (EPI-16)
Date and hour : Friday, November 11 at 5 p.m. ET
Session: Other anaphylaxis
Summary of data: Absorption of epinephrine via neffy 2.0 mg under rhinitis resulted in faster absorption due to nasal symptoms including mucosal edema. by neffy pharmacodynamic profile under rhinitis is comparable to manual injection, suggesting that neffy may be at least as effective as this approved product.

Title: Epinephrine nasal spray (ARS-1) and intramuscular injection:
Pharmacokinetic/pharmacodynamic differences and differential affinities for adrenergics
Receivers
Date and hour : Friday, November 11 at 5:15 p.m. ET
Session : Other anaphylaxis
Summary of data: neffy 1.0 mg increases systolic blood pressure and heart rate more effectively than injections, eliciting a pharmacodynamic response comparable to lower epinephrine concentration which may be attributed to its bypass of beta 2 receptors in skeletal muscle of the thigh .

Title: Time to use of epinephrine injectable devices and triggers Conduct: A
Patient/caregiver survey
Date and hour : Friday, Nov. 11 at 4:15 p.m. ET
Session : Adverse drug reactions, insect reactions, anaphylaxis
Summary of data: Reasons for delay in using an epinephrine injection device were significantly related to needle, need to go to the emergency room, uncertainty about symptom justifying injection, potential side effects, fear of using, pain and size of the device.
The results suggest that a device that addresses the reasons for delay and hesitation can help patients and caregivers use the device without hesitation.

Title: Epinephrine via a needle-free device would be administered sooner after symptoms: results of a survey of patients and caregivers
Date and hour : Friday, Nov. 11 at 4:45 p.m. ET
Session: Adverse drug reactions, insect reactions, anaphylaxis
Summary of data: A needle-free option for administering epinephrine would be used sooner after the onset of symptoms and is perceived to be easier to use compared to an injectable device. This highlights the need to develop epinephrine modalities using a needleless delivery system.

About Type I Allergic Reactions, Including Anaphylaxis
Severe Type I allergic reactions are serious and life-threatening events that can occur minutes after exposure to an allergen and require immediate treatment with epinephrine, the only drug approved by the FDA for these reactions. Although epinephrine auto-injectors have been shown to be very effective, there are well-published limitations that cause many patients and caregivers to delay or not administer treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle safety issues, unreliability, and device complexity. There are approximately 25 to 40 million people in the United States who experience severe Type I allergic reactions. Of these, only 3.3 million currently have an active prescription for epinephrine auto-injector, and among of these, only half systematically carry their prescribed auto-injector. 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 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® (formerly known as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions, including foods, drugs, and insect bites that can lead to life-threatening anaphylaxis . For more information, visit www.ars-pharma.com.

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. Such statements include, but are not limited to, data that will presented at the ACAAI. , as well as the dates and times of these presentations; the design and potential benefits of neffy®; the planned target action date of the PDUFA; potential regulatory approval and commercialization of neffy®; the potential market opportunity for neffy®; 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”, “plan”, “expect”, “will”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on ARS’ 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 these forward-looking statements due to various risks and uncertainties, which include, but are not limited to, the ability to obtain and maintain regulatory approval for neffy®; clinical trial results may not be indicative of results that may be seen in the future; the potential safety and other complications of neffy®; labeling for neffy®, if approved; the scope, progress and expansion of development and commercialization neffy®; the size and growth of the relevant market and the rate and degree of market acceptance thereof over intramuscular injectable products; ARS’s ability to protect its intellectual property position; and the impact of governmental laws and regulations. Additional risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements are included under “Risk Factors” and elsewhere in ARS’ most recent filings with the Securities and Exchange. United States Commission (SEC), including its definitive proxy statement dated October 6, 2022, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at www.sec.gov. These documents can be accessed on the ARS web page at ir.ars-pharma.com by clicking on the “Financials & Filings” link.

The forward-looking statements included in this presentation speak only as of the date hereof. ARS undertakes no obligation and does not intend to update these forward-looking statements, except as required by law.

ARS media contacts:
Caroline Cunningham
Wear Novelli
[email protected]

ARS Investor Contacts:
Justin Chakma
ARS Pharmaceutical
[email protected]

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