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News

ARS Pharmaceuticals Announces neffy Meets Primary Endpoints And Shows Rapid Symptom Control In Phase 2 Urticaria Clinical Study

Author: Benzinga Newsdesk | February 26, 2024 10:03am
  • neffy demonstrated statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema in treatment-resistant chronic spontaneous urticaria patients, a skin disorder that causes itchy hives and/or angioedema



     
  • Data supports continued development of neffy in urticaria with planned outpatient study in acute flares to initiate during 2024, with pivotal study to potentially initiate in 2025

     



SAN DIEGO, Feb. 26, 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 positive efficacy results in its phase 2 inpatient chronic spontaneous urticaria study with neffy (epinephrine nasal spray), an investigational new drug. 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, February 26, at 1:10 pm ET at the 2024 American Academy of Allergy, Asthma and Immunology (AAAAI) in Washington, D.C. in Room 207B (Level 2) of the Convention Center.

"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 David Bernstein, M.D., Emeritus Professor of Pediatrics at the Cincinnati Children's Hospital Medical Center, a former member of the Joint Task Force on Practice Parameters (urticaria guidelines) and Principal Investigator of the Study, "Urticaria symptoms clear within minutes after dosing, and neffy could offer patients a novel treatment option to address existing gaps in the efficacy of currently available antihistamines or biologics."

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