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S0597 helps significantly improve symptoms of seasonal allergic rhinitis

Various doses of S0597 helped to significantly improve symptoms of seasonal allergic rhinitis in patients compared with placebo, according to study results.

Philipp Badorrek, MD, the head of clinical airway research at Fraunhofer Institute for Toxicology and Experimental Medicine in Germany, and colleagues conducted a phase 2, randomized placebo controlled, double blinded, parallel-group, single-center study to analyze the efficacy, safety and tolerability of different doses of S0597 nasal spray compared with placebo in patients with seasonal allergic rhinitis.

The analysis included 159 patients aged 18 to 65 years. Patients received either 200 (n = 39), 400 (n = 40), or 800 (n = 40) µg/day or placebo (n = 40) for 15 days. At the start of the study and at days 15 and 16, patients underwent a 4-hour pollen challenge to assess the treatment efficacy measured by a change in total nasal symptom score (TNSS).

Patients reported significant improvements in TNSS from baseline to days 15 and 16 in all doses of S0597 compared with placebo (P = .0005). The greatest improvement occurred in patients receiving the highest dose (P < .001).

Patients reported 145 adverse events during the study, most of which patients listed as mild (68.3%) or moderate (27.6%) in intensity. Fifty-nine adverse events occurred as a direct result of the drug, with headaches listed as the most common in patients receiving all doses (n = 33).

The researchers compared these results with other studies to highlight the strengths of S0597.

“Unlike some other corticosteroids … S0597 has shown potent glucocorticoid receptor binding affinity to other sex steroid receptors and aldosterone,” the researchers wrote. “Furthermore, in preclinical models, S0597 has shown local anti-inflammatory activity, low oral bioavailability, and low potential for systemic adverse effects, leading to a high therapeutic index. These findings together with the present results suggest that S0597 compares favorably with existing [intranasal glucocorticoids] therapies in efficacy and side effects.” – by Ryan McDonald

Disclosure: Badorrek reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.