SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) announced today that its investigational drug neffy, an epinephrine nasal spray, has shown positive results in a phase 2 study for the treatment of chronic spontaneous urticaria (CSU), a skin condition characterized by itchy hives and angioedema. The company presented these findings at the American Academy of Allergy, Asthma and Immunology's annual meeting in Washington, D.C.
The study met primary endpoints, with both 1 mg and 2 mg doses of neffy demonstrating statistically significant and clinically meaningful improvements in itch, hives, urticaria, and erythema scores as early as five minutes after administration. Notably, 50% of chronic urticaria cases are resistant to first-line antihistamine treatments, highlighting the need for alternative therapies.
Neffy was well-tolerated in the trial, with the most common adverse event being nasal discomfort reported in five subjects. No serious adverse events were noted. These results suggest that neffy could offer a rapid onset of symptom relief for patients experiencing acute flares of urticaria, potentially reducing the need for emergency room visits or chronic use of systemic biologics.
The company plans to initiate an outpatient study for patients with frequent acute flares of urticaria on antihistamine treatment later in 2024. This will be followed by a potential pivotal study in 2025, contingent on the anticipated FDA approval of neffy for Type I allergic reactions, including anaphylaxis, in the second half of 2024.
ARS Pharmaceuticals is focused on developing solutions for patients at risk of severe allergic reactions potentially leading to anaphylaxis. Neffy is positioned as an alternative to epinephrine autoinjectors, with the aim to address limitations like fear of needles and portability that may hinder timely administration in emergencies.
This news is based on a press release statement.
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