ARS-2, Low-Dose Intranasal Epinephrine, Improves Urticaria Scores in Patients with Frequent Urticaria Flares: Phase 2 Study Results

https://www.jacionline.org/article/S0091-6749(23)02308-4/fulltext

The Journal of Allergy and Clinical immunology, Volume 153, ISSUE 2, SUPPLEMENT , AB255, February 2024. DOI: https://doi.org/10.1016/j.jaci.2023.11.817

David Bernstein, Neetu Talreja, MD, Thomas Casale, MD, Wayne Shreffler, MD PhD, Richard Lowenthal, PhD MBA, Sarina Tanimoto

Rationale

While symptoms of chronic spontaneous urticaria are typically controlled with antihistamines or anti-IgE antibodies, many patients still experience periodic acute exacerbations. A low-dose intranasal epinephrine spray (ARS-2) is being developed as a needle-free option for the treatment of severe allergic reactions and is expected to be a highly effective, safe, and easy-to-use option for the rapid treatment of urticaria exacerbations.

Methods

In this Phase 2 study (NCT05496465), patients with chronic spontaneous urticaria experiencing a flare were randomized to receive a single treatment of ARS-2 (1 mg and 2 mg doses) and placebo nasal spray and then crossed over to other treatment during subsequent flare events. Efficacy was assessed using patient-rated scores (patient-reported pruritus/hive score and visual analog scale for pain) and investigator-rated assessment (extent of urticaria and erythema score) from 5 minutes to 120 minutes post-dose.

Results

Both 1 mg and 2 mg doses of ARS-2 resulted in improvement starting at 5 minutes and persisting for 120 minutes post-dose; no changes were observed following the placebo spray. There were no meaningful differences in efficacy between the 1 mg and 2 mg doses of ARS-2. Statistically significant improvements (p<0.05) between ARS-2 and placebo were observed in all assessments.

Conclusions

These results demonstrate that the needle-free ARS-2 may be a safe and effective option for the treatment of urticaria exacerbations (flares). Given the similarities between the pathophysiology and clinical management of urticaria and anaphylaxis, these findings also support the efficacy of low-dose intranasal epinephrine for treating severe allergic reactions, including anaphylaxis.

Virus-free.www.avast.com