Global pharmaceutical company, Glenmark affirmed poster presentations of data from clinical studies of Ryaltris which is an investigational fixed-dose combination nasal spray for seasonal allergic rhinitis (SAR), at the AAAAI/WAO Joint Congress in Orlando, Florida.
Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals said “We have studied the safety and efficacy of Ryaltris in more than a thousand patients over several years, and we are pleased to share these data at the AAAAI/WAO Joint Congress.”
Data included in two of the posters are from Phase 3, double-blind, placebo and active-controlled studies (Study 1 and Study 2) that randomized more than 2,400 patients to 14 days of twice-daily treatment with Ryaltris or placebo. Both studies assessed average change from baseline, in morning and evening, reflective Total Nasal Symptom Score (rTNSS) versus active comparators and placebo as the primary endpoint. Onset of action versus placebo was assessed using instantaneous Total Nasal Symptom Score (iTNSS) from 15 minutes through four hours post-first dose.
Rapid onset of action with Ryaltris was witnessed with an effect seen at 15 minutes post-dose versus placebo in Study 1 (p=0.013) and study 2 (p=0.028) that was maintained at each subsequent time point assessed. Ryaltris also improved rTOSS versus placebo (p=0.001). Treatment emergent adverse events (TEAEs) were low and comparable across treatments.
The most frequent adverse events (AEs) reported with Ryaltris included decreased taste sensitivity (Study 1: Ryaltris 3.3%, placebo 0.7%; Study 2: Ryaltris 3.8%, placebo 0.0%) and headache.
Ryaltris resulted in statistically significant and clinically meaningful improvements in the primary efficacy endpoint of nasal symptom scores compared to placebo in Study 1, which was sustained for the entire treatment duration.
Frank Hampel, Principal Investigator, Central Texas Health Research said “These findings, combined with prior studies demonstrating the long-term effects of Ryaltris on patient-reported outcomes, present a promising profile for a potential new treatment for SAR.”
The study evaluated mean change in iTNSS as the primary endpoint. Onset of action was assessed by average change from baseline in iTNSS at time points from five minutes to four hours post-dose versus placebo. Ocular symptoms were also assessed using instantaneous Total Ocular Symptom Score (iTOSS). Onset of action with twice-daily Ryaltris versus placebo was observed at 10 minutes after the first dose (p=0.019) and was maintained at later time points except at 2.5 hours (p=0.06). Onset of action could not be defined for Ryaltris dosed once-daily. Ryaltris also improved symptoms in iTOSS compared to placebo.