Monday, ARS Pharmaceuticals Inc SPRY released 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 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.
There was no meaningful difference in efficacy on patient-reported itch severity score, patient-reported hives severity score, investigator-related extent of urticaria, or investigator-related erythema score between 1 mg and 2 mg neffy doses, indicating that the 1 mg dose may be sufficient to activate the beta-2 adrenergic receptors responsible for stopping the mast cell degranulation and allergic mediator release that leads to an urticaria flare.
Neffy was well-tolerated, with adverse events reported in 8 subjects, all mild or moderate in severity. The most common adverse event reported was nasal discomfort in 5 subjects. There were no serious adverse events.
Urticaria is a skin disorder driven by mast cell degranulation and histamine release, which causes itchy wheals (hives), angioedema, or both. In the United States, the annualized incidence is approximately 5 million cases. 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy.
ARS Pharma plans to initiate a placebo-controlled outpatient urticaria study in patients treated with antihistamines who experience frequent acute flares later in 2024, followed by the potential initiation of a single pivotal efficacy study in 2025. This would follow the anticipated FDA approval of neffy for allergic reactions (Type I), including anaphylaxis, in the second half of 2024.
Price Action: SPRY shares are up 5.15% at $8.78 on the last check Monday.
Photo: Darko Stojanovic from Pixabay
