Glenmark Pharmaceuticals, a global pharmaceutical company, declared combination presentations of data from three clinical studies of Ryaltris, an investigational fixed-dose combination nasal spray for seasonal allergic rhinitis (SAR), at the AAAAI/WAO Joint Congress in Orlando, Florida.
“Glenmark has a long history of expertise in respiratory diseases, and is focused on developing new and inventive treatments,” said Fred Grossman, president and chief medical officer at Glenmark Pharmaceuticals.
“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 into two of the posters (# 537 and # 546) 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.
The two studies surveyed average change from baseline, in morning and night, reflective Total Nasal Symptom Score (rTNSS) versus active comparators and placebo as the primary endpoint. The onset of action versus placebo was assessed utilizing instantaneous Total Nasal Symptom Score (iTNSS) from 15 minutes through four hours post-first dose.
Improvement in ocular symptoms, surveyed as mean change in Reflective Total Ocular Symptom Score (rTOSS) from baseline to study end, was also evaluated.
A rapid onset of action with Ryaltris was seen, with an impact seen at 15 minutes post-dosage versus placebo in Study 1 (p=0.013) and Study 2 (p=0.028), which was kept up at each ensuing time point assessed. In the two studies, Ryaltris also enhanced rTOSS versus placebo (p=0.001).
Treatment point unfavorable occasions (TEAEs) were low and practically identical crosswise over medications. The most frequent adverse events (AEs) announced with Ryaltris included diminished taste sensitivity (Study 1: Ryaltris 3.3%, placebo 0.7%; Study 2: Ryaltris 3.8%, placebo 0.0%) and headache (Study 1: Ryaltris 0.7%, placebo 2.8%; Study 2: Ryaltris 0.0%, placebo 0.7%).
Ryaltris brought about statistically significant and clinically important improvements in the primary efficacy endpoint of nasal symptom scores compared with placebo in Study 1, which was supported for the entire treatment duration.
“Results of these robust studies show that consistent, significant relief from symptoms might be rapidly achieved and supported with Ryaltris,” said Frank Hampel, Principal Investigator, and Central Texas Health Research.
“These discoveries, combined with earlier studies showing the long-term impacts of Ryaltris on patient-reported results, exhibit a promising profile for a potential new treatment for SAR.”
Data were also introduced from a double-blind, phase 2, proof-of-concept study that randomized 180 patients to 14 days of treatment with Ryaltris twice-every day or once-daily versus twice-daily azelastine/fluticasone, olopatadine hydrochloride or placebo in a ragweed pollen Environmental Exposure Chamber. The study evaluated mean change in iTNSS as the primary endpoint.
The onset of action was evaluated by the average change from baseline in iTNSS at the time indicates from five minutes four hours post-dose versus placebo. Ocular symptoms were also assessed utilizing instantaneous Total Ocular Symptom Score (iTOSS).
The onset of action with twice-daily Ryaltris versus placebo was seen at 10 minutes after the first dose (p=0.019) and was kept up at later time points aside from at 2.5 hours (p=0.06). The onset of action couldn’t be characterized for Ryaltris dosed once-daily.
Ryaltris also improved symptoms in iTOSS compared with placebo (once- daily p=0.015, twice- daily p=0.001). The percentage of patients announcing TEAEs was comparable between treatments. A headache (Ryaltris 11.1%, placebo 8.3%) and reduced taste sensitivity (Ryaltris 5.6%, placebo 0.0%) were the most common Aes detailed among patients taking Ryaltris twice-daily.